Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-02 @ 11:11 PM
Study NCT ID:
NCT03452202
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2018-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using tDCS in Speech-based Stroke Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001072', 'term': 'Apraxias'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-02-28', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in accuracy in recordings from tasks from baseline to post treatment', 'timeFrame': 'Baseline, 6 Months', 'description': 'Subjects will be given speech production tasks. Recordings of tasks will be scored for accuracy to measure speech motor learning'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Stroke'], 'conditions': ['Apraxia of Speech']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. Transcranial direct current stimulation (tDCS), which delivers low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a non-significant risk to participants. tDCS provides low intensity neural stimulation which has been shown to facilitate motor learning in other domains of stroke rehabilitation such as arm motor learning but the potential to enhance speech motor learning has not been explored. This will be examined with a series of single-case experimental designs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Right-handed\n* Monolingual (English)\n* Single left-hemisphere CVA\n* A minimum of six months post-stroke\n* Clinical diagnosis of apraxia of speech\n* Normal speech perception\n* Passing score on the hearing screening.\n\nExclusion Criteria:\n\n* Diagnosis of laryngeal voice disorder\n* Dysarthria\n* History of speech impairment prior to CVA\n* Presence of potential tDCS risk factors: damaged skin at site of stimulation;\n* Presence of electrically or magnetically activated implant (including pacemaker);\n* metal in any part of their body;\n* history of medication-resistant epilepsy in the family;\n* past history of seizures or unexplained spells of loss of consciousness.'}, 'identificationModule': {'nctId': 'NCT03452202', 'briefTitle': 'Using tDCS in Speech-based Stroke Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Using tDCS in Speech-based Stroke Rehabilitation', 'orgStudyIdInfo': {'id': '17-01474'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Stimulation', 'description': 'crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.', 'interventionNames': ['Device: Soterix 1x1 line tDCS low-intensity stimulator', 'Device: Sham']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Stimulation', 'description': 'crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.', 'interventionNames': ['Device: Soterix 1x1 line tDCS low-intensity stimulator', 'Device: Sham']}], 'interventions': [{'name': 'Soterix 1x1 line tDCS low-intensity stimulator', 'type': 'DEVICE', 'otherNames': ['Soterix'], 'description': 'Introduction of the independent variable (treatment) across three different points in time. Participants will be randomly assigned to have each treatment phase begin after 3, 4, or 6 baseline sessions. This current stimulates the cortex, with anodal stimulation leading to a depolarized state in which neurons are more likely to fire.', 'armGroupLabels': ['Active Stimulation', 'Sham Stimulation']}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'Patients will have two electrodes applied (one anode, one cathode) administering no stimulation', 'armGroupLabels': ['Active Stimulation', 'Sham Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Buchwald Lab', 'role': 'CONTACT', 'email': 'buchwald-lab@nyu.edu'}, {'name': 'Adam', 'role': 'CONTACT'}, {'name': 'Adam Buchwald, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10605', 'city': 'White Plains', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Josette Hartnett, MPH', 'role': 'CONTACT', 'email': 'johartnett@burke.org'}, {'name': 'Erika Trovato, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Burke Rehabilitation Hospital', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}], 'centralContacts': [{'name': 'Buchwald Lab', 'role': 'CONTACT', 'email': 'buchwald-lab@nyu.edu'}], 'overallOfficials': [{'name': 'Adam Buchwald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}