Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-01 @ 5:55 PM
Study NCT ID:
NCT02587234
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2015-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Driving Neuroplasticity With Nerve Stimulation and Modified CIT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], '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'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lumy.sawaki@uky.edu', 'title': 'Lumy Sawaki, MD, PhD', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Active PNS', 'description': '2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves', 'otherNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham PNS', 'description': '2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fall', 'notes': 'Subject sustained a fall at home during the intervention period of the study. The subject was evaluated by a doctor not associated with the study and no fractures or major trauma was detected. The event was determined to not be related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Wolf Motor Function Test (WMFT), Timed Portion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PNS', 'description': '2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves'}, {'id': 'OG001', 'title': 'Sham PNS', 'description': '2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves'}], 'classes': [{'title': 'Post-intervention minus baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'groupId': 'OG000', 'lowerLimit': '-0.45', 'upperLimit': '-0.27'}, {'value': '-0.18', 'groupId': 'OG001', 'lowerLimit': '-0.28', 'upperLimit': '-0.07'}]}]}, {'title': '1-month follow-up minus baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.37', 'groupId': 'OG000', 'lowerLimit': '-0.51', 'upperLimit': '-0.22'}, {'value': '-0.15', 'groupId': 'OG001', 'lowerLimit': '-0.29', 'upperLimit': '-0.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': 'Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline', 'unitOfMeasure': 'log(seconds)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects in the Sham PNS group were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Fugl Meyer Assessment Motor Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PNS', 'description': '2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves'}, {'id': 'OG001', 'title': 'Sham PNS', 'description': '2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves'}], 'classes': [{'title': 'Post-intervention minus baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '7.44', 'upperLimit': '12.96'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '2.34', 'upperLimit': '8.77'}]}]}, {'title': '1-month follow-up minus baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '7.52', 'upperLimit': '17.48'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '2.96', 'upperLimit': '9.61'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': 'Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The scores can range from 0 to 66, with higher scores indicating better performance. The scores are calculated by summing the scores to the 33 individual tasks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects from the Sham PNS group were lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Action Research Arm Test (ARAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PNS', 'description': '2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves'}, {'id': 'OG001', 'title': 'Sham PNS', 'description': '2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves'}], 'classes': [{'title': 'Post-intervention minus baseline', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '5.64', 'upperLimit': '13.57'}, {'value': '3.67', 'groupId': 'OG001', 'lowerLimit': '2.28', 'upperLimit': '5.05'}]}]}, {'title': '1-month follow-up minus baseline', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '5.43', 'upperLimit': '16.77'}, {'value': '4.43', 'groupId': 'OG001', 'lowerLimit': '2.67', 'upperLimit': '6.19'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': "Values given are score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline.\n\nThe ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).\n\nPerformance on each item is rated on a 4-point ordinal scale ranging from:\n\n3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty\n\n1: Performs test partially 0: Can perform no part of test The maximum score on the ARTS is 57 points (possible range 0 to 57).", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects from the Sham PNS group were lost to follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active', 'description': '2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves'}, {'id': 'FG001', 'title': 'Sham PNS', 'description': '2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active PNS', 'description': '2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves'}, {'id': 'BG001', 'title': 'Sham PNS', 'description': '2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training\n\nperipheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.7', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '54.6', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '55.7', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age calculations exclude the subject from the Active PNS group who withdrew during the interventions and the subject from the Sham PNS group who withdrew during the interventions.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Numbers do not include the 2 subjects who withdrew prior to completing the interventions.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2015-10-23', 'resultsFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-13', 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Wolf Motor Function Test (WMFT), Timed Portion', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': 'Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline'}], 'secondaryOutcomes': [{'measure': 'Change in Fugl Meyer Assessment Motor Score', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': 'Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The scores can range from 0 to 66, with higher scores indicating better performance. The scores are calculated by summing the scores to the 33 individual tasks.'}, {'measure': 'Change in Action Research Arm Test (ARAT)', 'timeFrame': 'baseline, post-intervention, 1-month follow-up', 'description': "Values given are score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline.\n\nThe ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).\n\nPerformance on each item is rated on a 4-point ordinal scale ranging from:\n\n3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty\n\n1: Performs test partially 0: Can perform no part of test The maximum score on the ARTS is 57 points (possible range 0 to 57)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['motor recovery', 'chronic', 'human', 'sensory', 'afferent input', 'motor training'], 'conditions': ['Stroke', 'Cerebrovascular Accident']}, 'referencesModule': {'references': [{'pmid': '26945226', 'type': 'DERIVED', 'citation': 'Carrico C, Chelette KC 2nd, Westgate PM, Salmon-Powell E, Nichols L, Sawaki L. Randomized Trial of Peripheral Nerve Stimulation to Enhance Modified Constraint-Induced Therapy After Stroke. Am J Phys Med Rehabil. 2016 Jun;95(6):397-406. doi: 10.1097/PHM.0000000000000476.'}]}, 'descriptionModule': {'briefSummary': 'The investigators proposed to evaluate the effectiveness of sustained peripheral nerve stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).', 'detailedDescription': 'Stroke is one the most devastating and prevalent diseases, but efforts to limit the amount of tissue damaged in the acute phase have been disappointing, highlighting the need for effective therapeutic interventions after neurologic damage has occurred. A major goal of the research in stroke rehabilitation is to harness the capacity of the brain to reorganize after neurologic damage has occurred and thus ultimately lead to successful recovery of function. Data from animal and human models have suggested that sensory input plays an important role in motor output, possibly by influencing cortical plasticity. However, in spite of the advances to date, little is known about the extent to which sensory input in the form of peripheral nerve stimulation can be successfully combined to physical training. A new emerging approach called constraint-induced therapy (CIT) is an intensive functional motor training and has produced promising results in the field of stroke rehabilitation. CIT involves restraining the unaffected arm with a sling or glove combined with intense task-oriented therapy of the affected side for six hours daily during 2 weeks. This pilot study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training to improve hand motor function. While the functional motor training follows identical principles of CIT, the length of daily training will be shortened to 4 hours daily and thus the investigators will refer in this proposal as a modified CIT. Preliminary data for this study demonstrated that peripheral nerve stimulation results in increased cortical motor excitability in normal subjects. In addition, learning and use-dependent plasticity can be substantially enhanced by a single session of 2 hours of peripheral nerve stimulation in chronic stroke patients. The goal of this study is to test the hypothesis that stroke patients treated with upper extremity peripheral nerve stimulation preceding CIT (intervention group) will have improved hand motor function compared to a group receiving lower extremity peripheral nerve stimulation and CIT (control group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic stroke patients\n* Single stroke\n* Chronic (more than 12 months after from stroke)\n* At least 21 years old, but there is no upper age range for this project.\n* Participants must be able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.\n\nExclusion Criteria:\n\n* History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies\n* History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness\n* Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery\n* Cognitive deficit severe enough to preclude informed consent\n* Positive pregnancy test or being of childbearing age and not using appropriate contraception\n* Participants with history of untreated depression.'}, 'identificationModule': {'nctId': 'NCT02587234', 'briefTitle': 'Driving Neuroplasticity With Nerve Stimulation and Modified CIT', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Driving Neuroplasticity With Nerve Stimulation and Modified Constraint-Induced Therapy', 'orgStudyIdInfo': {'id': 'R03HD049408', 'link': 'https://reporter.nih.gov/quickSearch/R03HD049408', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': '2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training', 'interventionNames': ['Device: peripheral nerve stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham PNS', 'description': '2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training', 'interventionNames': ['Device: peripheral nerve stimulation']}], 'interventions': [{'name': 'peripheral nerve stimulation', 'type': 'DEVICE', 'description': 'Non-invasive stimulation of median, ulnar and radial nerves', 'armGroupLabels': ['Active', 'Sham PNS']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kentucky', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lumy Sawaki', 'investigatorAffiliation': 'University of Kentucky'}}}}