Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT03642158
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2018-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
rTMS for Cognitive Rehabilitation After TBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-04-07', 'mcpReleaseN': 4, 'releaseDate': '2022-03-14'}], 'estimatedResultsFirstSubmitDate': '2022-03-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blinded'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2018-08-20', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Auditory target detection task', 'timeFrame': '10 minutes', 'description': 'subjects listen to a series of sounds, and will monitor for a specific sounds.'}, {'measure': 'Ruffs 2 and 7 selective attention test', 'timeFrame': '~5 minutes', 'description': 'subjects must visually search for the numbers 2 and 7 among other distractors.'}, {'measure': 'DKEFS Verbal Fluency', 'timeFrame': '10 minutes', 'description': 'a measure of internal search and selection process, requires subject to generate several lists of items.'}, {'measure': 'California Verbal Learning Test II', 'timeFrame': '10 minutes', 'description': 'subjects are required to learn and recall an unfamiliar word list.'}], 'secondaryOutcomes': [{'measure': 'EEG', 'timeFrame': '10 minutes', 'description': 'resting state power spectra of EEG will be collected to analyze.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cognitive Impairment', 'Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'A novel and promising therapy for cognitive dysfunction is non-invasive brain stimulation, of which transcranial magnetic stimulation (TMS) is a form. TMS is currently FDA-approved for use in depression and migraine. It is under investigation for use in a number of other neurologic and psychiatric disorders. In addition to its potential to improve affective symptoms, recent research has suggested that TMS targeted to select cortical regions can also improve cognition. In trials of TMS therapy for psychiatric disorders, several studies have shown benefits for cognitive function alongside symptom amelioration. In healthy persons, a course of stimulation of the parietal area improved objective measures of learning and memory. Among persons with TBI, there have been case reports supporting improvement in cognitive function and postconcussive symptoms; however, there have not yet been any controlled studies of TMS for TBI-related cognitive dysfunction.', 'detailedDescription': 'Subjects with a history of TBI will be recruited into this double-blind, sham controlled, crossover with washout study design. Study will involve one week (5 consecutive days) of treatment, a 7 day off period, followed by a second week of rTMS treatment. Motor threshold will determine level of stimulation, and active rTMS stimulation will occur of the right DLPFC. Subjects will be paid for their time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. one or more mild to moderate TBIs\\*;\n2. at least one year but no more than 20 years from worst injury;\n3. ability to complete cognitive and neurophysiological testing;\n4. available for duration of study;\n5. between 18 and 65 years of age;\n6. mild or greater cognitive symptoms on the TBI-QOL Cognition General Concerns scale\n\nExclusion Criteria:\n\n1. severe or penetrating TBI;\n2. history of psychotic or manic illness;\n3. history of intracranial surgery;\n4. history of skull fracture;\n5. history of seizures in candidate or candidate's family\n6. ferrous metallic implants or implantable medical device;\n7. medications that are known to reduce seizure threshold;\n8. pregnancy.\n9. history of multiple sclerosis, stroke, brain tumor, epilepsy"}, 'identificationModule': {'nctId': 'NCT03642158', 'briefTitle': 'rTMS for Cognitive Rehabilitation After TBI', 'organization': {'class': 'FED', 'fullName': 'Hunter Holmes Mcguire Veteran Affairs Medical Center'}, 'officialTitle': 'Targeted Transcranial Magnetic Stimulation for Cognitive Rehabilitation After Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '02332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active TMS', 'description': 'Subjects receive rTMS over the right DLPFC, in 2 second bursts at 10 Hz, followed by a 19 second break, for a total of 20 minutes. Stimulator intensity is set to 80% of motor threshold on day one, and 100% of motor threshold for the remainder of intervention. This paradigm is continued for 5 consecutive days.', 'interventionNames': ['Device: repetitive Transcranial Magnetic Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham TMS', 'description': 'Identical to active arm, but stimulator intensity is reduced to 30% of motor threshold, and the stimulator coil is oriented tangentially to the skull to "stimulate" air space above the head instead of cortical tissue.', 'interventionNames': ['Device: repetitive Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'repetitive Transcranial Magnetic Stimulation (rTMS) utilizes a magnetic coil of wire to non-invasively and painlessly activate small sections of the brain through the skull.', 'armGroupLabels': ['Active TMS', 'Sham TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire Veterans Affairs Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunter Holmes Mcguire Veteran Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Virginia Commonwealth Neurotrauma Initiative', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director of Clinical Research, Parksinon's Disease Education, Research and Clinical Center (PADRECC)", 'investigatorFullName': 'George Gitchel', 'investigatorAffiliation': 'Hunter Holmes Mcguire Veteran Affairs Medical Center'}}}}