Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-02-28 @ 3:58 AM
Study NCT ID:
NCT02465034
Status:
TERMINATED
Last Update Posted:
2021-11-26
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Noninvasive Brain Stimulation to Evaluate Neural Plasticity After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.borich@emory.edu', 'phone': '404-712-0612', 'title': 'Dr. Michael Borich', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected from the time the intervention began through the final follow up assessment (up to 4 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With Subcortical Stroke', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function undergoing noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation will also be used which will be one of the following, a traditional or a corticocortical or a sham paired associative stimulation protocol. The subjects also underwent median nerve stimulation.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Controls', 'description': 'Healthy individuals underwent noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was also used, which was either a traditional or a corticocortical or a sham paired associative stimulation protocol.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Long-term Potentiation-like Plasticity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcortical Stroke PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving paired associative stimulation (PAS). PAS is a combination of transcranial magnetic stimulation (TMS) and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. Median nerve stimuli at 300% of the perceptual threshold is applied 25ms prior to transcranial magnetic stimulation delivery over the ipsilesional (stroke) or non-dominant (control) cortex.'}, {'id': 'OG001', 'title': 'Subcortical Stroke PAS Sham', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham paired associative stimulation (PAS).'}, {'id': 'OG002', 'title': 'Subcortical Stroke CC-PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.'}, {'id': 'OG003', 'title': 'Subcortical Stroke CC-PAS Sham', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham cortico-cortical paired associative stimulation (CC-PAS).'}, {'id': 'OG004', 'title': 'Healthy Control Group', 'description': 'Healthy participants received noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was also used.'}, {'id': 'OG005', 'title': 'Healthy Control Sham', 'description': 'Healthy participants receiving sham paired associative stimulation (PAS).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '813.86', 'spread': '619.81', 'groupId': 'OG000'}, {'value': '819.47', 'spread': '387.37', 'groupId': 'OG001'}, {'value': '665.14', 'spread': '645.05', 'groupId': 'OG002'}, {'value': '427.80', 'spread': '360.45', 'groupId': 'OG003'}, {'value': '1408.08', 'spread': '871.52', 'groupId': 'OG004'}, {'value': '1025.60', 'spread': '451.76', 'groupId': 'OG005'}]}]}, {'title': '1 minute post-PAS', 'categories': [{'measurements': [{'value': '1455.77', 'spread': '1383.06', 'groupId': 'OG000'}, {'value': '883.74', 'spread': '424.24', 'groupId': 'OG001'}, {'value': '644.46', 'spread': '627.70', 'groupId': 'OG002'}, {'value': '525.34', 'spread': '502.67', 'groupId': 'OG003'}, {'value': '1777.57', 'spread': '1192.83', 'groupId': 'OG004'}, {'value': '1121.38', 'spread': '641.96', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 Minute Post-Paired Associative Stimulation', 'description': 'Long-term potentiation-like plasticity was measured using paired associative stimulation (PAS). PAS consists of repeated peripheral electric stimulation paired with Transcranial Magnetic Stimulation (TMS) applied to the motor cortex at varying interstimulus intervals. Participants received 180 paired stimuli at 0.25 hertz (Hz) for 12 minutes. Impaired long-term potentiation-like plasticity points towards reduced excitatory synaptic connectivity and deficits in sensorimotor integration. Decrease or no change in the amplitudes of motor-evoked potentials (MEPs) indicates impaired long-term potentiation-like plasticity.', 'unitOfMeasure': 'microvolts (µV)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants with complete and usable data. Errors with data acquisition occurred with three participants in the stroke PAS assessment, two participants in the stroke CC-PAS assessment, and three healthy controls. Two additional control participants were not included in the analysis due to data quality issues.'}, {'type': 'PRIMARY', 'title': 'Electroencephalography Recordings at Baseline and 5 MInutes Post-PAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcortical Stroke CC-PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.'}, {'id': 'OG001', 'title': 'Subcortical Stroke CC-PAS Sham', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham cortico-cortical paired associative stimulation (CC-PAS).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': '5 minutes post-PAS', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 5 Minutes Post-Paired Associative Stimulation', 'description': 'Electroencephalography (EEG) data were recorded using a 64-channel TMS-compatible electrode cap (Easy Cap). Signals were collected at 2000 hertz (Hz) during pre- and post-transcranial magnetic stimulation epochs (-100ms to 200ms). Up to fifty suprathreshold (120% AMT) transcranial magnetic stimulation pulses were applied to motor cortex while the subject was seated quietly with eyes open. This procedure was conducted bilaterally. Data epochs (-1000 to 4000 ms with respect to TMS delivery) were extracted for subsequent imaginary phase coherence analysis. Post-TMS coherence values between electrodes overlying M1 bilaterally (C3 and C4) were calculated within the beta frequency range (15 to 30 Hz). EEG data values are unit-free that can range from 0 to 1. Higher values represent greater coherence which is thought to indicate stronger connectivity.', 'unitOfMeasure': 'coefficient of coherence', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving CC-PAS were studied for this outcome. Errors with data acquisition occurred with two participants. Data were not collected for one participant due to EEG equipment malfunction, and not collected for one participant due to time constraints.'}, {'type': 'PRIMARY', 'title': 'Abbreviated Wolf Motor Function Test Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcortical Stroke CC-PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.'}, {'id': 'OG001', 'title': 'Subcortical Stroke CC-PAS Sham', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham cortico-cortical paired associative stimulation (CC-PAS).'}], 'classes': [{'title': 'Hand to Table Baseline', 'categories': [{'measurements': [{'value': '1.34', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Hand to Table 10 Minutes Post-PAS', 'categories': [{'measurements': [{'value': '1.22', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Stack Checkers Baseline', 'categories': [{'measurements': [{'value': '3.72', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '3.26', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Stack Checkers 10 Minutes Post-PAS', 'categories': [{'measurements': [{'value': '3.03', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '2.26', 'groupId': 'OG001'}]}]}, {'title': 'Lift Can Baseline', 'categories': [{'measurements': [{'value': '7.76', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '6.17', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Lift Can 10 Minutes Post-PAS', 'categories': [{'measurements': [{'value': '7.40', 'spread': '4.47', 'groupId': 'OG000'}, {'value': '7.19', 'spread': '2.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 10 Minutes Post-Paired Associative Stimulation', 'description': 'Three items of the Wolf Motor Function Test (WMFT) were used to evaluate functional motor performance. The 3 items were selected based on task difficulty ranging from easiest (hand to table) to most difficult (stack checkers) along with a task of moderate difficulty (lift can). Each task has different control demands and number of actions required to complete successfully. Task performance is timed in seconds, with a maximum time of 120 seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving CC-PAS were studied for this outcome. Errors with data acquisition occurred with two participants.'}, {'type': 'SECONDARY', 'title': 'Wolf Motor Function Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcortical Stroke PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving paired associative stimulation (PAS). PAS is a combination of transcranial magnetic stimulation (TMS) and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. Median nerve stimuli at 300% of the perceptual threshold is applied 25ms prior to transcranial magnetic stimulation delivery over the ipsilesional (stroke) or non-dominant (control) cortex.'}, {'id': 'OG001', 'title': 'Subcortical Stroke CC-PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.79', 'spread': '10.74', 'groupId': 'OG000'}, {'value': '23.30', 'spread': '47.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The arm function in subjects in the subcortical stroke group was evaluated by the Wolf Motor Function Test (WMFT). The test consists of timed and functional tasks and has 17 items. It is composed of 3 parts: Time, functional ability and strength and includes 15 function-based tasks and 2 strength based tasks. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The examiner will test the less affected upper extremity followed by the most affected side. Scores are based on time taken to complete each task. The median time to complete all tasks will be be used to evaluate motor function. Larger values indicate greater upper extremity motor dysfunction.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants with subcortical stroke, during the active PAS and CC-PAS assessments. Errors with data acquisition occurred with three participants in the stroke PAS assessment and two participants in the stroke CC-PAS assessment. This test was not performed for three participants receiving CC-PAS due to time constraints.'}, {'type': 'SECONDARY', 'title': 'Abbreviated Wolf Motor Function Test Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcortical Stroke CC-PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.'}, {'id': 'OG001', 'title': 'Subcortical Stroke CC-PAS Sham', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS).'}], 'classes': [{'title': 'Hand to Table 30 minutes post-PAS', 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Hand to Table 24 hours post-PAS', 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Stack Checkers 30 minutes post-PAS', 'categories': [{'measurements': [{'value': '3.15', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Stack Checkers 24 hours post-PAS', 'categories': [{'measurements': [{'value': '3.45', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': 'Lift Can 30 minutes post-PAS', 'categories': [{'measurements': [{'value': '7.23', 'spread': '3.83', 'groupId': 'OG000'}, {'value': '7.79', 'spread': '5.33', 'groupId': 'OG001'}]}]}, {'title': 'Lift Can 24 hours post-PAS', 'categories': [{'measurements': [{'value': '7.23', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '6.28', 'spread': '2.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation', 'description': 'Three items of the WMFT were used to evaluate functional motor performance. The 3 items were selected based on task difficulty ranging from easiest (hand to table) to most difficult (stack checkers) along with a task of moderate difficulty (lift can). Each task has different control demands and number of actions required to complete successfully. Task performance will be timed, with a maximum time of 120 seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving CC-PAS were studied for this outcome. Errors with data acquisition occurred with two participants.'}, {'type': 'SECONDARY', 'title': 'Long-term Potentiation-like Plasticity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcortical Stroke PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving paired associative stimulation (PAS). PAS is a combination of transcranial magnetic stimulation (TMS) and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. Median nerve stimuli at 300% of the perceptual threshold is applied 25ms prior to transcranial magnetic stimulation delivery over the ipsilesional (stroke) or non-dominant (control) cortex.'}, {'id': 'OG001', 'title': 'Subcortical Stroke PAS Sham', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham paired associative stimulation (PAS).'}, {'id': 'OG002', 'title': 'Subcortical Stroke CC-PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.'}, {'id': 'OG003', 'title': 'Subcortical Stroke CC-PAS Sham', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham cortico-cortical paired associative stimulation (CC-PAS).'}, {'id': 'OG004', 'title': 'Healthy Control Group', 'description': 'Healthy participants received noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was also used.'}, {'id': 'OG005', 'title': 'Healthy Control Sham', 'description': 'Healthy participants receiving sham paired associative stimulation (PAS).'}], 'classes': [{'title': '30 minutes post-PAS', 'categories': [{'measurements': [{'value': '1162.76', 'spread': '585.18', 'groupId': 'OG000'}, {'value': '847.61', 'spread': '421.28', 'groupId': 'OG001'}, {'value': '532.66', 'spread': '510.49', 'groupId': 'OG002'}, {'value': '503.87', 'spread': '472.50', 'groupId': 'OG003'}, {'value': '1757.44', 'spread': '960.64', 'groupId': 'OG004'}, {'value': '1310.29', 'spread': '684.84', 'groupId': 'OG005'}]}]}, {'title': '24 hours post-PAS', 'categories': [{'measurements': [{'value': '1176.71', 'spread': '737.16', 'groupId': 'OG000'}, {'value': '749.86', 'spread': '352.13', 'groupId': 'OG001'}, {'value': '424.17', 'spread': '410.79', 'groupId': 'OG002'}, {'value': '445.29', 'spread': '438.84', 'groupId': 'OG003'}, {'value': '1542.62', 'spread': '1219.24', 'groupId': 'OG004'}, {'value': '1387.98', 'spread': '758.53', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation', 'description': 'Long-term potentiation-like plasticity was measured using paired associative stimulation (PAS). PAS consists of repeated peripheral electric stimulation paired with Transcranial Magnetic Stimulation (TMS) applied to the motor cortex at varying interstimulus intervals. Participants receive 180 paired stimuli at 0.25 Hz for 12 minutes. Impaired long-term potentiation-like plasticity points towards reduced excitatory synaptic connectivity and deficits in sensorimotor integration. Decrease or no change in the amplitudes of motor-evoked potentials (MEPs) indicates impaired long-term potentiation-like plasticity.', 'unitOfMeasure': 'microvolts (µV)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants with complete and usable data. Errors with data acquisition occurred with three participants in the stroke PAS assessment, two participants in the stroke CC-PAS assessment, and three healthy controls. Two additional control participants were not included in the analysis due to data quality issues. Data from one participant with subcortical stroke receiving CC-PAS was not able to be analyzed due to excessive noise in the signal.'}, {'type': 'SECONDARY', 'title': 'Electroencephalography Recordings at 30 Minutes and 24 Hours Post-PAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcortical Stroke CC-PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.'}, {'id': 'OG001', 'title': 'Subcortical Stroke CC-PAS Sham', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS).'}], 'classes': [{'title': '30 minutes post-PAS', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': '24 hours post-PAS', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation', 'description': 'Electroencephalography (EEG) data were recorded using a 64-channel TMS-compatible electrode cap (Easy Cap). Signals were collected at 2000 hertz (Hz) during pre- and post-transcranial magnetic stimulation epochs (-100ms to 200ms). Up to fifty suprathreshold (120% AMT) transcranial magnetic stimulation pulses were applied to motor cortex while the subject was seated quietly with eyes open. This procedure was conducted bilaterally. Data epochs (-1000 to 4000 ms with respect to TMS delivery) were extracted for subsequent imaginary phase coherence analysis. Post-TMS coherence values between electrodes overlying M1 bilaterally (C3 and C4) were calculated within the beta frequency range (15 to 30 Hz). EEG data values are unit-free that can range from 0 to 1. Higher values represent greater coherence which is thought to indicate stronger connectivity.', 'unitOfMeasure': 'coefficient of coherence', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants receiving CC-PAS were studied for this outcome. Errors with data acquisition occurred with two participants. Data were not collected for one participant due to EEG equipment malfunction and not collected for another participant due to time constraints.'}, {'type': 'SECONDARY', 'title': 'Serial Reaction Time Task (SRTT) Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcortical Stroke PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving paired associative stimulation (PAS). PAS is a combination of transcranial magnetic stimulation (TMS) and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. Median nerve stimuli at 300% of the perceptual threshold is applied 25ms prior to transcranial magnetic stimulation delivery over the ipsilesional (stroke) or non-dominant (control) cortex.'}, {'id': 'OG001', 'title': 'Subcortical Stroke PAS Sham', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham paired associative stimulation (PAS).'}, {'id': 'OG002', 'title': 'Subcortical Stroke CC-PAS', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving cortico-cortical paired associative stimulation (CC-PAS). CC-PAS is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval ranges from 5-15 ms depending on site of stimulation.'}, {'id': 'OG003', 'title': 'Subcortical Stroke CC-PAS Sham', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function receiving sham cortico-cortical paired associative stimulation (CC-PAS).'}, {'id': 'OG004', 'title': 'Healthy Control Group', 'description': 'Healthy participants received noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was also used.'}, {'id': 'OG005', 'title': 'Healthy Control Sham', 'description': 'Healthy participants receiving sham paired associative stimulation (PAS).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '805.00', 'spread': '188.63', 'groupId': 'OG000'}, {'value': '1030.26', 'spread': '398.40', 'groupId': 'OG001'}, {'value': '19.21', 'spread': '54.01', 'groupId': 'OG002'}, {'value': '13.02', 'spread': '67.51', 'groupId': 'OG003'}, {'value': '45.13', 'spread': '43.68', 'groupId': 'OG004'}, {'value': '52.30', 'spread': '48.71', 'groupId': 'OG005'}]}]}, {'title': '10 minutes post-PAS', 'categories': [{'measurements': [{'value': '806.00', 'spread': '155.60', 'groupId': 'OG000'}, {'value': '838.12', 'spread': '172.58', 'groupId': 'OG001'}, {'value': '-1.69', 'spread': '142.72', 'groupId': 'OG002'}, {'value': '28.38', 'spread': '114.26', 'groupId': 'OG003'}, {'value': '52.73', 'spread': '53.43', 'groupId': 'OG004'}, {'value': '57.50', 'spread': '59.76', 'groupId': 'OG005'}]}]}, {'title': '30 minutes post-PAS', 'categories': [{'measurements': [{'value': '812.80', 'spread': '192.42', 'groupId': 'OG000'}, {'value': '788.40', 'spread': '197.86', 'groupId': 'OG001'}, {'value': '9.35', 'spread': '36.69', 'groupId': 'OG002'}, {'value': '3.99', 'spread': '70.74', 'groupId': 'OG003'}, {'value': '66.16', 'spread': '63.71', 'groupId': 'OG004'}, {'value': '61.61', 'spread': '57.97', 'groupId': 'OG005'}]}]}, {'title': '24 hours post-PAS', 'categories': [{'measurements': [{'value': '726.00', 'spread': '112.81', 'groupId': 'OG000'}, {'value': '790.25', 'spread': '199.97', 'groupId': 'OG001'}, {'value': '-14.21', 'spread': '114.31', 'groupId': 'OG002'}, {'value': '8.94', 'spread': '81.99', 'groupId': 'OG003'}, {'value': '83.41', 'spread': '82.96', 'groupId': 'OG004'}, {'value': '77.05', 'spread': '51.59', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 10 minutes post-PAS, 30 minutes post-PAS, and 24 hours post-PAS', 'description': 'The SRTT involves pressing a key that corresponds to a target square positioned on a screen in front of the participant as quickly and accurately as possible. The response time for repeated and random sequences evaluate SRTT performance and skill is measured as the difference in response times between repeated and random sequences. Lower response times indicate better performance and a larger positive difference in response times represents greater sequence-specific skill. Negative values represent better performance on random sequences compared to repeated sequences.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Errors with data acquisition occurred with three participants in the stroke PAS assessment, two participants in the stroke CC-PAS assessment, and three healthy controls. Two additional control participants were not included due to data quality issues. One participant with subcortical stroke receiving PAS and two receiving CC-PAS were unable to perform the task due to severe upper extremity motor impairment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Subcortical Stroke', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function undergoing noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was used where participants received traditional PAS and sham PAS or a cortico-cortical paired associative stimulation (CC-PAS) and sham CC-PAS. Participants also underwent median nerve stimulation.'}, {'id': 'FG001', 'title': 'Healthy Controls', 'description': 'Healthy individuals underwent noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was used where participants received traditional PAS and sham PAS.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Started PAS', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Completed PAS', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Started CC-PAS', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Completed CC-PAS', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Screen fail', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Could not be scheduled for study visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participant enrollment began in May 2015 and all study follow up was completed by July 24, 2019. Study activities took place at the Emory Wesley Woods Health Center in Atlanta, Georgia.', 'preAssignmentDetails': 'Forty-five individuals gave consent to participate in the study and were enrolled into the appropriate study arm based on health status. Four screen failed or withdrew resulting in 41 who participated in the study. Participants with subcortical stroke could take part in both the PAS and CC-PAS studies.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Subcortical Stroke', 'description': 'Participants with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function undergoing noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was used where participants received traditional PAS and sham PAS or a cortico-cortical paired associative stimulation (CC-PAS) and sham CC-PAS. Participants also underwent median nerve stimulation.'}, {'id': 'BG001', 'title': 'Healthy Controls', 'description': 'Healthy individuals underwent noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation was used where participants received traditional PAS and sham PAS.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '26.3', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '39.9', 'spread': '18.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline analysis includes all individuals who consented to participate in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-28', 'size': 343257, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-29T09:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'whyStopped': 'Enrollment and study activities were suspended due to COVID-19.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'dispFirstSubmitDate': '2021-04-26', 'completionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2015-06-03', 'dispFirstSubmitQcDate': '2021-04-30', 'resultsFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2015-06-04', 'dispFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-29', 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Long-term Potentiation-like Plasticity', 'timeFrame': 'Baseline, 1 Minute Post-Paired Associative Stimulation', 'description': 'Long-term potentiation-like plasticity was measured using paired associative stimulation (PAS). PAS consists of repeated peripheral electric stimulation paired with Transcranial Magnetic Stimulation (TMS) applied to the motor cortex at varying interstimulus intervals. Participants received 180 paired stimuli at 0.25 hertz (Hz) for 12 minutes. Impaired long-term potentiation-like plasticity points towards reduced excitatory synaptic connectivity and deficits in sensorimotor integration. Decrease or no change in the amplitudes of motor-evoked potentials (MEPs) indicates impaired long-term potentiation-like plasticity.'}, {'measure': 'Electroencephalography Recordings at Baseline and 5 MInutes Post-PAS', 'timeFrame': 'Baseline, 5 Minutes Post-Paired Associative Stimulation', 'description': 'Electroencephalography (EEG) data were recorded using a 64-channel TMS-compatible electrode cap (Easy Cap). Signals were collected at 2000 hertz (Hz) during pre- and post-transcranial magnetic stimulation epochs (-100ms to 200ms). Up to fifty suprathreshold (120% AMT) transcranial magnetic stimulation pulses were applied to motor cortex while the subject was seated quietly with eyes open. This procedure was conducted bilaterally. Data epochs (-1000 to 4000 ms with respect to TMS delivery) were extracted for subsequent imaginary phase coherence analysis. Post-TMS coherence values between electrodes overlying M1 bilaterally (C3 and C4) were calculated within the beta frequency range (15 to 30 Hz). EEG data values are unit-free that can range from 0 to 1. Higher values represent greater coherence which is thought to indicate stronger connectivity.'}, {'measure': 'Abbreviated Wolf Motor Function Test Time', 'timeFrame': 'Baseline, 10 Minutes Post-Paired Associative Stimulation', 'description': 'Three items of the Wolf Motor Function Test (WMFT) were used to evaluate functional motor performance. The 3 items were selected based on task difficulty ranging from easiest (hand to table) to most difficult (stack checkers) along with a task of moderate difficulty (lift can). Each task has different control demands and number of actions required to complete successfully. Task performance is timed in seconds, with a maximum time of 120 seconds.'}], 'secondaryOutcomes': [{'measure': 'Wolf Motor Function Test', 'timeFrame': 'Baseline', 'description': 'The arm function in subjects in the subcortical stroke group was evaluated by the Wolf Motor Function Test (WMFT). The test consists of timed and functional tasks and has 17 items. It is composed of 3 parts: Time, functional ability and strength and includes 15 function-based tasks and 2 strength based tasks. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The examiner will test the less affected upper extremity followed by the most affected side. Scores are based on time taken to complete each task. The median time to complete all tasks will be be used to evaluate motor function. Larger values indicate greater upper extremity motor dysfunction.'}, {'measure': 'Abbreviated Wolf Motor Function Test Time', 'timeFrame': '30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation', 'description': 'Three items of the WMFT were used to evaluate functional motor performance. The 3 items were selected based on task difficulty ranging from easiest (hand to table) to most difficult (stack checkers) along with a task of moderate difficulty (lift can). Each task has different control demands and number of actions required to complete successfully. Task performance will be timed, with a maximum time of 120 seconds.'}, {'measure': 'Long-term Potentiation-like Plasticity', 'timeFrame': '30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation', 'description': 'Long-term potentiation-like plasticity was measured using paired associative stimulation (PAS). PAS consists of repeated peripheral electric stimulation paired with Transcranial Magnetic Stimulation (TMS) applied to the motor cortex at varying interstimulus intervals. Participants receive 180 paired stimuli at 0.25 Hz for 12 minutes. Impaired long-term potentiation-like plasticity points towards reduced excitatory synaptic connectivity and deficits in sensorimotor integration. Decrease or no change in the amplitudes of motor-evoked potentials (MEPs) indicates impaired long-term potentiation-like plasticity.'}, {'measure': 'Electroencephalography Recordings at 30 Minutes and 24 Hours Post-PAS', 'timeFrame': '30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation', 'description': 'Electroencephalography (EEG) data were recorded using a 64-channel TMS-compatible electrode cap (Easy Cap). Signals were collected at 2000 hertz (Hz) during pre- and post-transcranial magnetic stimulation epochs (-100ms to 200ms). Up to fifty suprathreshold (120% AMT) transcranial magnetic stimulation pulses were applied to motor cortex while the subject was seated quietly with eyes open. This procedure was conducted bilaterally. Data epochs (-1000 to 4000 ms with respect to TMS delivery) were extracted for subsequent imaginary phase coherence analysis. Post-TMS coherence values between electrodes overlying M1 bilaterally (C3 and C4) were calculated within the beta frequency range (15 to 30 Hz). EEG data values are unit-free that can range from 0 to 1. Higher values represent greater coherence which is thought to indicate stronger connectivity.'}, {'measure': 'Serial Reaction Time Task (SRTT) Performance', 'timeFrame': 'Baseline, 10 minutes post-PAS, 30 minutes post-PAS, and 24 hours post-PAS', 'description': 'The SRTT involves pressing a key that corresponds to a target square positioned on a screen in front of the participant as quickly and accurately as possible. The response time for repeated and random sequences evaluate SRTT performance and skill is measured as the difference in response times between repeated and random sequences. Lower response times indicate better performance and a larger positive difference in response times represents greater sequence-specific skill. Negative values represent better performance on random sequences compared to repeated sequences.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Neural plasticity', 'Noninvasive brain stimulation', 'Motor cortex'], 'conditions': ['Cerebrovascular Stroke']}, 'referencesModule': {'references': [{'pmid': '29721010', 'type': 'DERIVED', 'citation': 'Borich MR, Wolf SL, Tan AQ, Palmer JA. Targeted Neuromodulation of Abnormal Interhemispheric Connectivity to Promote Neural Plasticity and Recovery of Arm Function after Stroke: A Randomized Crossover Clinical Trial Study Protocol. Neural Plast. 2018 Mar 12;2018:9875326. doi: 10.1155/2018/9875326. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine how different areas in the brain interact with each other and how using brain imaging and brain stimulation approaches can influence these interactions.', 'detailedDescription': 'Subcortical strokes affect small vessels deep in the brain, and typically present with motor hemiparesis. The investigator will assess the effects of Transcranial Magnetic Stimulation (TMS) on motor function and examine how different areas in the human brain interact with each other using brain imaging and brain stimulation. The investigator will also evaluate the capacity for noninvasive stimulation to transiently modify brain activity supporting arm movement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18-85 years\n2. Middle cerebral artery stroke\n3. Individuals with a first time stroke that affects the corona radiata and/or internal capsule\n\nExclusion Criteria:\n\n1. Age outside the age range of 18-85 years\n2. Signs of dementia (score \\< 24 on the Montreal Cognitive Assessment)\n3. Aphasia (score \\< 13 on the Frenchay Aphasia Screen)\n4. History of head trauma\n5. History of a major psychiatric diagnosis\n6. History of a neurodegenerative disorder\n7. History of substance abuse\n8. Contraindications to Transcranial Magnetic Stimulation'}, 'identificationModule': {'nctId': 'NCT02465034', 'briefTitle': 'Noninvasive Brain Stimulation to Evaluate Neural Plasticity After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Noninvasive Brain Stimulation to Evaluate Neural Plasticity After Stroke', 'orgStudyIdInfo': {'id': 'IRB00081268'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Subcortical stroke', 'description': 'Subjects with subcortical stroke in the chronic phase of recovery with mild-moderate impairment of arm function will undergo noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation will also be used which will be one of the following, a traditional or a corticocortical or a sham paired associative stimulation protocol. The subjects will also undergo median nerve stimulation.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation', 'Device: Traditional Paired Associative Stimulation', 'Device: Median Nerve Stimulation', 'Device: Corticocortical Paired Associative Stimulation', 'Device: Sham Paired Associative Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Control', 'description': 'Healthy individuals will undergo noninvasive targeting of cortical locations by stereotactic neuronavigation using Transcranial Magnetic Stimulation (TMS), median nerve stimulation and arm motor function assessments. A paired associative stimulation (PAS) protocol using noninvasive stimulation will also be used which will be one of the following, a traditional or a corticocortical or a sham paired associative stimulation protocol.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation', 'Device: Traditional Paired Associative Stimulation', 'Device: Median Nerve Stimulation', 'Device: Corticocortical Paired Associative Stimulation', 'Device: Sham Paired Associative Stimulation']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'otherNames': ['Magstim BiStim^2'], 'description': 'Transcranial Magnetic Stimulation (TMS) will be performed using the Magstim BiStim\\^2 paired pulse stimulator to measure transient cortical excitability. Single pulse transcranial magnetic stimulation applied at low frequencies (not greater than 0.25 hertz (Hz)) will be used. The may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.', 'armGroupLabels': ['Healthy Control', 'Subcortical stroke']}, {'name': 'Traditional Paired Associative Stimulation', 'type': 'DEVICE', 'otherNames': ['Magstim BiStim^2'], 'description': 'Paired associative stimulation (PAS) is a combination of transcranial magnetic stimulation (TMS) and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. Median nerve stimuli at 300% of the perceptual threshold will be applied 25ms prior to transcranial magnetic stimulation delivery over the ipsilesional (stroke) or non-dominant (control) cortex. Transcranial Magnetic Stimulation (TMS) will be performed using the Magstim BiStim\\^2 paired pulse stimulator unit and a bipolar bar electrode will be used for median nerve stimulation. This traditional paired associative stimulation may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.', 'armGroupLabels': ['Healthy Control', 'Subcortical stroke']}, {'name': 'Median Nerve Stimulation', 'type': 'DEVICE', 'description': 'Stimulation of the median nerve will be performed using a bipolar bar electrode affixed to palmar aspect of the forearm proximal to the crease of the wrist bilaterally. Stimuli will be delivered 23ms prior to the transcranial magnetic stimulation (TMS) pulse with 0.1 milliseconds (ms) rectangular pulses at an intensity to evoke a 1 millivolt (mV) response in the abductor pollicis brevis (APB) muscle. This may may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.', 'armGroupLabels': ['Healthy Control', 'Subcortical stroke']}, {'name': 'Corticocortical Paired Associative Stimulation', 'type': 'DEVICE', 'otherNames': ['Magstim BiStim^2'], 'description': 'Cortico-cortical Paired Associative Stimulation (CC-PAS) is a combination of TMS and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25 Hz for 12 minutes. The interstimulus interval will range from 5-15 ms depending on site of stimulation.TMS will be performed using the Magstim BiStim\\^2 paired pulse stimulator unit and a bipolar bar electrode will be used for median nerve stimulation. This CC-PAS may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.', 'armGroupLabels': ['Healthy Control', 'Subcortical stroke']}, {'name': 'Sham Paired Associative Stimulation', 'type': 'DEVICE', 'otherNames': ['Magstim BiStim^2'], 'description': 'The sham PAS is a combination of TMS and electrical stimulation of the median nerve. The coil is rotated and separated from the head with a plastic spacer to ensure indirect contact with the head.180 paired stimuli are delivered at 0.25 Hz for 12 minutes. TMS will be performed using the Magstim BiStim\\^2 paired pulse stimulator unit and a bipolar bar electrode will be used for median nerve stimulation. This sham paired associative stimulation may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.', 'armGroupLabels': ['Healthy Control', 'Subcortical stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wesley Woods Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Michael Borich, DPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michael R Borich', 'investigatorAffiliation': 'Emory University'}}}}