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

Not Applicable

Completed

• Conditions: Blast Injury; Traumatic Brain Injury; Cognitive Dysfunction
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Cognitive Intervention

• Registration Number: NCT01596569
• Lead Sponsor: Boston Medical Center

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-11
• Primary Completion: 2017-11-18
• Study Completion: 2017-11-18
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active TMS and Cognitive Intervention	Repetitive Transcranial Magnetic Stimulation (rTMS)	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).
Sham TMS and Cognitive Intervention:	Repetitive Transcranial Magnetic Stimulation (rTMS)	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).
Active TMS and Cognitive Intervention	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).
Sham TMS and Cognitive Intervention:	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).

Primary Outcome Measures

Name	Time	Method
Post concussive symptoms in TBI	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 Outcome Measures

Name	Time	Method
Daily life and functional outcome	4 weeks	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.
PTSD symptoms	4 weeks	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..

Trial Locations

Locations (2)

VA Boston Healthcare System; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States