Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury (COST-TBI)

Boston Medical Center (BMC)

Status: Completed

Conditions: Traumatic Brain Injury; Cognitive Dysfunction; Blast Injury

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Cognitive Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01596569

H-29706

UL1RR025771 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 2 patient groups

Active TMS and Cognitive Intervention

Active Comparator group

Description:

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).

Treatment:

Behavioral: Cognitive Intervention

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham TMS and Cognitive Intervention:

Sham Comparator group

Description:

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).

Treatment:

Behavioral: Cognitive Intervention

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)