Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 8:27 AM
Study NCT ID:
NCT03038269
Status:
UNKNOWN
Last Update Posted:
2022-10-04
First Post:
2017-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tDCS and Robotic Training in Adults With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-02', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment of Motor Recovery', 'timeFrame': '1 Week', 'description': 'Evaluates and measures recovery'}], 'secondaryOutcomes': [{'measure': 'Wolf Motor Function Test', 'timeFrame': '1 Week', 'description': 'Quantifies upper extremity motor ability through timed and functional tasks'}, {'measure': 'Box and Blocks Test', 'timeFrame': '1 Week', 'description': 'Measures unilateral gross motor dexterity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Robotics', 'Upper Extremity'], 'conditions': ['Cerebral Palsy', 'Hemiplegia']}, 'referencesModule': {'references': [{'pmid': '28505986', 'type': 'RESULT', 'citation': 'Friel KM, Lee P, Soles LV, Smorenburg ARP, Kuo HC, Gupta D, Edwards DJ. Combined transcranial direct current stimulation and robotic upper limb therapy improves upper limb function in an adult with cerebral palsy. NeuroRehabilitation. 2017;41(1):41-50. doi: 10.3233/NRE-171455.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve arm function in adults with hemiplegic cerebral palsy. Participants will receive transcranial direct current stimulation (or sham) in combination with upper extremity robotic therapy.', 'detailedDescription': 'Therapy consists of 20 minutes of non-invasive, low-level brain stimulation (transcranial direct current stimulation, tDCS), followed by one hour of shoulder/wrist robotic training. Participants will be enrolled in therapy 3 times per week for 12 weeks (or 36 sessions). Before and after therapy, participants will receive and assessment of their arm function, as well as an assessment of their brain activity, using electroencephalography (EEG) and transcranial magnetic stimulation (TMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant willing and able to provide informed consent\n* Diagnosis of hemiplegic Cerebral Palsy\n* Joint mobility: wrist extention (20 degrees), metacarophalangeal and proximal interphalangeal joints (10 degrees)\n\nExclusion Criteria:\n\n* Cognitive deficits that impede understanding of study protocol\n* Current medical illness unrelated to CP\n* Visual problems (uncorrected by glasses/contact lenses)\n* High motor ability in affected arm\n* Severe spasticity\n* Lack of asymmetry in hand function\n* Orthopedic surgery in affected arm within 2 years\n* Dorsal root rhizotomy\n* Botulinum toxin therapy in either upper extremity during last 2 months, or planned during study period\n* Currently receiving intrathecal baclofen\n* Seizure beyond age 2, use of anti-seizure medication, history of epilepsy (in self or first degree relatives), brain surgery, cranial metal implants, structural brain lesion, deices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)\n* True positive response on the Transcranial Magnetic Stimulation Safety Screen\n* Current use of medications known to lower the seizure threshold\n* Previous episode of neurocardiogenic snycopy'}, 'identificationModule': {'nctId': 'NCT03038269', 'briefTitle': 'tDCS and Robotic Training in Adults With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Burke Medical Research Institute'}, 'officialTitle': 'Transcranial Direct Current Stimulation and Robotic Training in Adults With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'BRC 467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'Participant will receive a placebo-type stimulation followed by upper extremity robotic training.', 'interventionNames': ['Behavioral: Upper Extremity Robotics, tDCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active tDCS', 'description': 'Participant will receive active transcranial direct current stimulation followed by upper extremity robotic training.', 'interventionNames': ['Behavioral: Upper Extremity Robotics, tDCS']}], 'interventions': [{'name': 'Upper Extremity Robotics, tDCS', 'type': 'BEHAVIORAL', 'description': 'Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.', 'armGroupLabels': ['Active tDCS', 'Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10605', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'Burke Medical Research Institute', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burke Medical Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Laboratory for Early Brain Injury Recovery', 'investigatorFullName': 'Kathleen Friel', 'investigatorAffiliation': 'Burke Medical Research Institute'}}}}