Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI

Conditions
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Traumatic Brain Injury, Cognitive Dysfunction, Blast Injury

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
* Behavioral: Cognitive Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active TMS and Cognitive Intervention<br>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)<br>* Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.<br>* Other names: Magstim Corporation;Behavioral: Cognitive Intervention<br>* 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.<br>* Other names: Cognitive Training;|
| Sham Comparator: Sham TMS and Cognitive Intervention:<br>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)<br>* Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.<br>* Other names: Magstim Corporation;Behavioral: Cognitive Intervention<br>* 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.<br>* Other names: Cognitive Training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post concussive symptoms in TBI | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily life and functional outcome | 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. | 4 weeks | 
| PTSD symptoms | 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.. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blast Traumatic Brain Injury, Cognitive Rehabilitation, Transcranial Magnetic Stimulation, Combined Treatment