Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Medical Center
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Post concussive symptoms in TBI
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- All
- 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
Arms & Interventions
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).
Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
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).
Intervention: Cognitive Intervention (Behavioral)
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).
Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
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).
Intervention: Cognitive Intervention (Behavioral)
Outcomes
Primary Outcomes
Post concussive symptoms in TBI
Time Frame: 4 weeks
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.
Secondary Outcomes
- Daily life and functional outcome(4 weeks)
- PTSD symptoms(4 weeks)
Investigators
Yelena Bogdanova, PhD
BUMC Faculty
Boston Medical Center