Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-01 @ 3:18 PM
Study NCT ID:
NCT00542256
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2007-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tDCS and Physical Therapy in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098483', 'term': 'Constraint Induced Movement Therapy'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2007-10-10', 'studyFirstSubmitQcDate': '2007-10-10', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Jebsen-Taylor Hand Function Test', 'timeFrame': 'Baseline, Treatment days 1,5,10, Follow Up'}, {'measure': 'Motor Activity Log Rating Scale', 'timeFrame': 'Baseline, Treatment Days 1,5,10 and Follow Up'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'Baseline, Treatment days 1,5,10 and Follow up'}, {'measure': 'Visual Analogue Scale for Anxiety', 'timeFrame': 'Baseline, Treatment days 1,5,10 and Follow Up'}], 'secondaryOutcomes': [{'measure': 'Fugl Meyer Assessment of Motor Recovery', 'timeFrame': 'Baseline Assessment'}, {'measure': 'Barthel Index Score', 'timeFrame': 'Baseline Assessment'}, {'measure': 'Modified Ashworth Scale', 'timeFrame': 'Baseline Assessment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Apoplexy', 'Cerebral Stroke', 'Cerebrovascular Accident, Acute', 'Cerebrovascular Apoplexy', 'Cerebrovascular Stroke', 'CVA (Cerebrovascular Accident)', 'Stroke', 'Stroke, Acute', 'Vascular Accident, Brain'], 'conditions': ['Cerebrovascular Accident']}, 'referencesModule': {'references': [{'pmid': '33175411', 'type': 'DERIVED', 'citation': 'Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.'}], 'seeAlsoLinks': [{'url': 'http://www.tmslab.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.\n\nWe hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed)\n* Demonstrates adequate balance while wearing a hand restraint on the unaffected arm\n* Ability to stand from a sitting position and ability to stand with or without upper extremity support\n* Stroke onset at least 6 months prior to study enrollment\n\nExclusion Criteria:\n\n* Significant pre-stroke disability\n* Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing\n* Excessive pain in any joint of the paretic extremity\n* A terminal medical diagnosis consistent with survival of less than 1 year\n* Advanced liver, kidney, cardiac, or pulmonary disease\n* Coexistent major neurological or psychiatric disease (including epilepsy)\n* A history of significant alcohol or drug abuse in the prior 3 years\n* Use of neuropsychotropic drugs - such as antidepressants\n* Patients may not be actively enrolled in a separate intervention study targeting stroke recovery\n* Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke'}, 'identificationModule': {'nctId': 'NCT00542256', 'briefTitle': 'tDCS and Physical Therapy in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients', 'orgStudyIdInfo': {'id': '2007P000420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each of the 10 weekday training sessions, participants will receive 40 minutes of active tDCS over the primary motor cortex.', 'interventionNames': ['Device: Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each training day tDCS will be applied for 40 minutes with the current active for only 30 seconds over the primary motor cortex.', 'interventionNames': ['Device: Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy']}], 'interventions': [{'name': 'Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy', 'type': 'DEVICE', 'description': '14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes.', 'armGroupLabels': ['1']}, {'name': 'Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy', 'type': 'DEVICE', 'description': '14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Felipe Fregni, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Felipe Fregni', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}