Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-27 @ 9:46 PM
Study NCT ID:
NCT04048668
Status:
WITHDRAWN
Last Update Posted:
2024-08-07
First Post:
2019-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tDCS to Treat Subacute Aphasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication 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'}]}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Suspended due to COVID-19', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2019-08-05', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Aphasia Severity', 'timeFrame': 'Baseline, Immediate Follow-up', 'description': 'Measured by WAB AQ score. A higher score indicated better language function. Scores can range from 0-100 with any score over 93 considered "recovered".'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-invasive brain stimulation', 'tDCS'], 'conditions': ['Aphasia', 'Stroke, Acute']}, 'descriptionModule': {'briefSummary': "This study proposes to use transcranial direct current stimulation (tDCS), a technique by which a very small electrical current (2 mA) is applied to the scalp, along side speech therapy in patients with subacute stroke and aphasia in order to enhance language recovery. Aphasic patients in an inpatient neurorehabilitation facility who have experienced a stroke between one week and three months prior to enrollment will be invited to participate. Participants will receive either real or sham tDCS to the left hemisphere of the brain for a minimum of 5 consecutive sessions to up-to a max of 10 sessions depending on the length of their rehab stay . Stimulation will be paired with with the patient's normal speech therapy schedule. Participant's language skills will be assessed at baseline and immediately after the last session of therapy in order to determine whether tDCS is associated with either transient or persistent improvement in language.", 'detailedDescription': "Speech therapy is the standard of care nationwide in treating individuals who have had a stroke and are now experiencing aphasia. Speech therapy can help to rehabilitate language skills and supplement function by teaching alternate strategies for communication; however, these benefits often leave room for further improvement. Researchers have focused their efforts in combining speech therapy with other techniques to boost the effects. In this study, we will combine speech therapy with non-invasive brain stimulation, specifically transcranial direct current stimulation (tDCS), in the hopes of significantly improve language in subacute aphasia patients.\n\nThis is a double-blind, randomized, sham-controlled pilot project, where inpatients with subacute stroke and aphasia will be recruited from the Penn Institute for Rehabilitation Medicine hospital (PIRM). The typical patient admitted to PIRM is approximately 1-2 weeks post-stroke. Upon enrollment, baseline aphasia severity will be characterized using standardized measures such as the Western Aphasia Battery (WAB), Pyramids and Palm Trees (PPT) and Philadelphia Naming Test (PNT) by the patient's speech therapist. Subjects will subsequently be randomized to undergo either real or sham tDCS. Subjects will then undergo a minimum of 5-consectuive stimulation session (Monday-Friday) and maximum of 10-consecutive stimulation sessions (Monday-Friday) of either real or sham tDCS. During stimulation, subjects will receive either real tDCS at a current of 2.0 mA for 20 minutes or sham stimulation for an equivalent period of time with a 30sec ramp-up/ramp-down. Sham stimulation mimics real stimulation closely; most subjects cannot distinguish between real and sham tDCS. During stimulation visits subjects will concurrently participate in their regular speech therapy treatment. Speech Therapy will be administered by their speech therapist and will follow whatever protocol the therapist deems useful for standard of care treatment of their aphasia. An immediate follow-up session will also take place, subjects will repeat language batteries including the WAB, PPT and PNT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Presence of aphasia attributable to stroke that occurred between 7 days and 3 months (inclusive) prior to inclusion in the study.\n* 2\\. Must be able to understand the nature of the study, and give informed consent.\n* 3\\. English must be their native language where "native" is defined as learning English before the age of 6\n\nExclusion Criteria:\n\n* 1\\. History of chronic, serious, or unstable neurologic illness(es) other than stroke\n* 2\\. Current unstable medical illness(es)\n* 3\\. History of reoccurring seizures or epilepsy\n* 4\\. Current abuse of alcohol or drugs\n* 5\\. Active or History of major psychiatric disorder\n* 6\\. Pregnancy\n* 7\\. Subjects with metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.'}, 'identificationModule': {'nctId': 'NCT04048668', 'briefTitle': 'tDCS to Treat Subacute Aphasia', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Transcranial Direct Current Stimulation to Enhance Language Recovery in Patients With Aphasia After Subacute Stroke', 'orgStudyIdInfo': {'id': '813736'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anodal tDCS', 'description': '2mA for 20 minutes', 'interventionNames': ['Device: Transcranial Direct Current Stimulation (tDCS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': '30 second ramp-up / ramp-down for 20 minutes', 'interventionNames': ['Device: Transcranial Direct Current Stimulation (tDCS)']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation (tDCS)', 'type': 'DEVICE', 'otherNames': ['Standard of Care Speech Therapy'], 'description': 'tDCS is a non-invasive brain stimulation technique by which very small electrical currents (2 mA) are applied to the scalp.', 'armGroupLabels': ['Anodal tDCS', 'Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Institute for Rehabilitation Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}