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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Boston Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01596569
First received: May 7, 2012
Last updated: September 20, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention Phase
Traumatic Brain Injury
Cognitive Dysfunction
Blast Injury
Device: Repetitive Transcranial Magnetic Stimulation (rTMS), MagStim
Behavioral: Cognitive Intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Cognitive Functioning [ Time Frame: Ten Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily Functioning [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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), MagStim
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), MagStim
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596569

Contacts
Contact: Yelena Bogdanova, PhD, PhD 857-364-2249 bogdanov@bu.edu
Contact: Sarah Kark, BS 857-364-4001 skark@bu.edu

Locations
United States, Massachusetts
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02130
Contact: Yelena Bogdanova, PhD, PhD    857-364-2249    bogdanov@bu.edu   
Contact: Sarah Kark, BS    857-364-4001    skark@bu.edu   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Alvaro Pascual-Leone, MD, PhD    617-667-0269    aconnor@bidmc.harvard.edu   
Contact: Ann Connor, RN    617-667-0269    aconnor@bidmc.harvard.edu   
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Yelena Bogdanova, PhD, PhD Boston University
  More Information

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01596569     History of Changes
Other Study ID Numbers: CCST, UL1RR025771
Study First Received: May 7, 2012
Last Updated: September 20, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Boston Medical Center:
Blast Traumatic Brain Injury
Cognitive Rehabilitation
Transcranial Magnetic Stimulation
Combined Treatment

Additional relevant MeSH terms:
Barotrauma
Blast Injuries
Brain Injuries
Cognition Disorders
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014