NCT01596569

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

Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury
• Cognitive Dysfunction
• Blast Injury

Interventions

Type	Name	Description
DEVICE	Repetitive Transcranial Magnetic Stimulation (rTMS)	Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2017-11-18
• Completion: 2017-11-18
• First posted: 2012-05-11
• Last updated: 2018-10-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study