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

Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI

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).

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02130
      • VA Boston Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	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.; Other Names: Transcranial Magnetic Stimulation; Noninvasive Brain Stimulation; Magstim Corporation; 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.; Other Names: Cognitive Rehabilitation; Cognitive Training
Sham Comparator: 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).	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.; Other Names: Transcranial Magnetic Stimulation; Noninvasive Brain Stimulation; Magstim Corporation; 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.; Other Names: Cognitive Rehabilitation; Cognitive Training

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Yelena Bogdanova, PhD, Boston University

Publications and helpful links

General Publications

• Bogdanova Y, Verfaellie M. Cognitive sequelae of blast-induced traumatic brain injury: recovery and rehabilitation. Neuropsychol Rev. 2012 Mar;22(1):4-20. doi: 10.1007/s11065-012-9192-3. Epub 2012 Feb 17.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): November 18, 2017
• Study Completion (Actual): November 18, 2017

Study Registration Dates

• First Submitted: May 7, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 11, 2012

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation; Cognitive Rehabilitation; Combined Treatment; Blast Traumatic Brain Injury
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Cognition Disorders; Barotrauma; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Cognitive Dysfunction; Blast Injuries
• Other Study ID Numbers: H-29706; UL1RR025771 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes