Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-03 @ 5:54 PM
Study NCT ID:
NCT03230695
Status:
UNKNOWN
Last Update Posted:
2022-10-28
First Post:
2017-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Therapy and Brain Stimulation in the Early Phase After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2017-07-24', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Movement Smoothness', 'timeFrame': 'Kinematic assessment at baseline, immediately after intervention; and 24h after.', 'description': 'The speed shape, calculated as mean speed divided by peak speed.'}], 'secondaryOutcomes': [{'measure': 'Number of peaks of the movement', 'timeFrame': 'kinematic assessment at baseline, immediately after intervention; and 24h after.', 'description': 'Number of peaks of the movement is calculated as the negative of the number of peaks in the speed profile.'}, {'measure': 'Jerk metric of the movement', 'timeFrame': 'kinematic assessment at baseline, immediately after intervention; and 24h after', 'description': 'Jerk metric of the movement is calculated by dividing the negative mean jerk magnitude by the peak speed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'robotic therapy', 'transcranial direct current stimulation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is the second cause of death worldwide and the majority of the survivors remain with motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as a potential intervention to enhance effects of other rehabilitation strategies on improvement of motor performance of the paretic upper limb. In this proof-of-concept study we will evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere associated with robotic therapy on improvement of motor performance of the paretic upper limb in the early phase post-stroke.', 'detailedDescription': 'The main goal of this study is to test the proof of concept of benefits of inhibition of the motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics of motor performance, in patients with upper limb paresis in the early phase post-stroke. For this purpose, patients will be randomized to receive real or sham transcranial direct current stimulation before a session of robotic therapy. Data will be collected by kinematic assessment performed automatically by the robot at baseline, immediately after and 24h after the intervention.\n\nThe working hypothesis is that one session of upper limb motor training will lead to improvement of performance in metrics of kinematics, and this improvement will be maintained up to 24h after the end of the training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nIschemic or hemorrhagic stroke onset from 3 days to 9 weeks before, confirmed by computed tomography or magnetic resonance imaging.\n\nMotor impairment of an upper limb, defined as a score between 1 - 3 in the Medical Research Council Scale, for at lest one the following movements: elbow extension, shoulder flexion, or shoulder extension.\n\nAbility to provide written informed consent.\n\nAbility to comply with the schedule of interventions and evaluations in the protocol.\n\nExclusion Criteria:\n\nSevere spasticity at the paretic elbow, wrist or fingers, defined as a score of \\> 3 in the Modified Ashworth Spasticity Scale.\n\nNo active shoulder and elbow movements\n\nUncontrolled medical problems such as end-stage cancer or renal disease\n\nPregnancy\n\nPotential contraindications to transcranial direct current stimulation: history of seizures, lesions on the scalp, intracranial metal implants, prior intracranial surgery, use of drugs that interfere on cortical excitability (such as antiepileptic drugs, benzodiazepines)\n\nOther neurological disorders such as Parkinson's disease\n\nPsychiatric illness\n\nAphasia or severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.\n\nHemineglect\n\nCerebellar lesions or on cerebellar pathways\n\nContact precautions"}, 'identificationModule': {'nctId': 'NCT03230695', 'briefTitle': 'Robotic Therapy and Brain Stimulation in the Early Phase After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effects of Robotic Therapy and Transcranial Direct Current Stimulation on Motor Performance of the Paretic Upper Limb in the Early Phase After Stroke', 'orgStudyIdInfo': {'id': 'RCT2129001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active stimulation + robotic therapy', 'description': 'Active transcranial direct current stimulation will be applied during 20 minutes prior to robotic training.\n\nNumber of interventions sessions: 1', 'interventionNames': ['Device: Robotic Therapy', 'Device: Active stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation + robotic therapy', 'description': 'Sham transcranial direct current stimulation will be applied during 20 minutes prior to robotic training.\n\nNumber of interventions sessions: 1', 'interventionNames': ['Device: Robotic Therapy', 'Device: Sham stimulation']}], 'interventions': [{'name': 'Robotic Therapy', 'type': 'DEVICE', 'description': 'Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.', 'armGroupLabels': ['Active stimulation + robotic therapy', 'Sham stimulation + robotic therapy']}, {'name': 'Active stimulation', 'type': 'DEVICE', 'description': 'Active transcranial direct current stimulation will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).', 'armGroupLabels': ['Active stimulation + robotic therapy']}, {'name': 'Sham stimulation', 'type': 'DEVICE', 'description': 'In sham transcranial direct current stimulation, no current will be delivered through the transcranial direct current stimulation device after the first 30 seconds.', 'armGroupLabels': ['Sham stimulation + robotic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403900', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Suzana Bleckmann Reis', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Adriana B Conforto, D, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}