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

Traumatic Brain Injury Clinical Trial

— COST-TBI  

Official title:

Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596569
• Other study ID #: H-29706
• Secondary ID: UL1RR025771
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: November 18, 2017

Study information

• Verified date: October 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 18, 2017
• Est. primary completion date: November 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Blast Injuries
• Blast Injury
• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Dysfunction
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	VA Boston Healthcare System	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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