Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT01596569
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2012-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D001753', 'term': 'Blast Injuries'}], 'ancestors': [{'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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001469', 'term': 'Barotrauma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}, {'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2012-05-07', 'studyFirstSubmitQcDate': '2012-05-09', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post concussive symptoms in TBI', 'timeFrame': '4 weeks', 'description': "Neurobehavioral Symptoms Inventory (NSI) is a 22-item measure that assesses the post-concussive symptoms in patients with TBI.The NSI asks the patient to rate each of the symptoms according to how much the symptom has disturbed him/her using a five point scale. Patient ratings are based on descriptions of the frequency of the symptom, the extent to which the symptom disrupts the patient's activities, and the patient's perceived need for help with the symptom. A total score will be summated. Lower scores are more favorable."}], 'secondaryOutcomes': [{'measure': 'Daily life and functional outcome', 'timeFrame': '4 weeks', 'description': 'Dysexecutive Questionnaire (DEX) is a 20-item self-report measure of real-life deficits relevant to cognitive/executive function that measures four domains: emotional, motivational, behavioral and cognitive. All items are rates in terms of frequency on a 5-point scale: 0 (never), 1(occasionally), 2 (sometimes), 3 (fairly often), 4 (very often). Scores are summed and the total scores range from 0 to 80, with higher scores indicating greater problems with executive functioning.'}, {'measure': 'PTSD symptoms', 'timeFrame': '4 weeks', 'description': 'Military version (PCL-M) 17-item self-report measure that assesses PTSD symptoms. Each item is scored on the frequency of the problem from 1 to 5 where 1= not at all and 5= extremely. A total score is calculated and lower scores are more favorable..'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Blast Traumatic Brain Injury', 'Cognitive Rehabilitation', 'Transcranial Magnetic Stimulation', 'Combined Treatment'], 'conditions': ['Traumatic Brain Injury', 'Cognitive Dysfunction', 'Blast Injury']}, 'referencesModule': {'references': [{'pmid': '22350691', 'type': 'BACKGROUND', 'citation': 'Bogdanova Y, Verfaellie M. Cognitive sequelae of blast-induced traumatic brain injury: recovery and rehabilitation. Neuropsychol Rev. 2012 Mar;22(1):4-20. doi: 10.1007/s11065-012-9192-3. Epub 2012 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the efficacy of a novel neurorehabilitation program combining noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive therapy, on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).', 'detailedDescription': 'The most common blast-induced traumatic brain injury (bTBI)-associated problems are cognitive deficits, such as executive functioning and memory. This study evaluates a combined rehabilitation program: transcranial magnetic stimulation (TMS) and cognitive therapy for treatment of patients with bTBI. TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular brain region. Half of the study participants will receive cognitive intervention with active TMS, and a control group will receive cognitive intervention with sham TMS. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System and Beth Israel Deaconess Medical Center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OEF/OIF active-duty personnel or veterans exposed to blast\n* Meets criteria for mild TBI\n* LOC of 30 min or less\n* Age: 21-50\n* Primary language is English\n\nExclusion Criteria:\n\n* Evidence of penetrating head injury\n* History of previous neurological diagnosis\n* History of previous psychotic disorder prior to the blast exposure\n* Hearing or vision impairment'}, 'identificationModule': {'nctId': 'NCT01596569', 'acronym': 'COST-TBI', 'briefTitle': 'Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI', 'orgStudyIdInfo': {'id': 'H-29706'}, 'secondaryIdInfos': [{'id': 'UL1RR025771', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR025771', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active TMS and Cognitive Intervention', 'description': 'Active TMS and Cognitive Intervention:\n\nRepetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory).', 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation (rTMS)', 'Behavioral: Cognitive Intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham TMS and Cognitive Intervention:', 'description': 'Sham TMS and Cognitive Intervention:\n\nRepetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory).', 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation (rTMS)', 'Behavioral: Cognitive Intervention']}], 'interventions': [{'name': 'Repetitive Transcranial Magnetic Stimulation (rTMS)', 'type': 'DEVICE', 'otherNames': ['Transcranial Magnetic Stimulation', 'Noninvasive Brain Stimulation', 'Magstim Corporation'], 'description': 'Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.', 'armGroupLabels': ['Active TMS and Cognitive Intervention', 'Sham TMS and Cognitive Intervention:']}, {'name': 'Cognitive Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Rehabilitation', 'Cognitive Training'], 'description': 'Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory) in bTBI.\n\nAll participants receive weekly cognitive treatment sessions for 10 weeks.', 'armGroupLabels': ['Active TMS and Cognitive Intervention', 'Sham TMS and Cognitive Intervention:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Boston Healthcare System', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Yelena Bogdanova, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BUMC Faculty', 'investigatorFullName': 'Yelena Bogdanova, PhD', 'investigatorAffiliation': 'Boston Medical Center'}}}}