Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury (COST-TBI)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Traumatic Brain Injury Cognitive Dysfunction Blast Injury |
Device: Repetitive Transcranial Magnetic Stimulation (rTMS), MagStim Behavioral: Cognitive Intervention |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI |
- Cognitive Functioning [ Time Frame: Ten Weeks ] [ Designated as safety issue: No ]
- Daily Functioning [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Active TMS and Cognitive Intervention
Active TMS and Cognitive Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory). |
Device: Repetitive Transcranial Magnetic Stimulation (rTMS), MagStim
Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.
Other Names:
Behavioral: Cognitive Intervention
Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory) in bTBI. All participants receive weekly cognitive treatment sessions for 10 weeks. Other Names:
|
|
Sham Comparator: Sham TMS and Cognitive Intervention:
Sham TMS and Cognitive Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory). |
Device: Repetitive Transcranial Magnetic Stimulation (rTMS), MagStim
Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.
Other Names:
Behavioral: Cognitive Intervention
Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory) in bTBI. All participants receive weekly cognitive treatment sessions for 10 weeks. Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- OEF/OIF active-duty personnel or veterans exposed to blast
- Meets criteria for mild TBI
- LOC of 30 min or less
- Age: 21-50
- Primary language is English
Exclusion Criteria:
- Evidence of penetrating head injury
- History of previous neurological diagnosis
- History of previous psychotic disorder prior to the blast exposure
- Hearing or vision impairment
Contacts and Locations| Contact: Yelena Bogdanova, PhD, PhD | 857-364-2249 | bogdanov@bu.edu |
| Contact: Sarah Kark, BS | 857-364-4001 | skark@bu.edu |
| United States, Massachusetts | |
| VA Boston Healthcare System | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: Yelena Bogdanova, PhD, PhD 857-364-2249 bogdanov@bu.edu | |
| Contact: Sarah Kark, BS 857-364-4001 skark@bu.edu | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Alvaro Pascual-Leone, MD, PhD 617-667-0269 aconnor@bidmc.harvard.edu | |
| Contact: Ann Connor, RN 617-667-0269 aconnor@bidmc.harvard.edu | |
| Principal Investigator: | Yelena Bogdanova, PhD, PhD | Boston University |
More Information
No publications provided
| Responsible Party: | Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT01596569 History of Changes |
| Other Study ID Numbers: | CCST, UL1RR025771 |
| Study First Received: | May 7, 2012 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Boston Medical Center:
|
Blast Traumatic Brain Injury Cognitive Rehabilitation Transcranial Magnetic Stimulation Combined Treatment |
Additional relevant MeSH terms:
|
Blast Injuries Brain Injuries Cognition Disorders Barotrauma Wounds and Injuries Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013