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

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ClinicalTrials.gov Identifier: NCT01596569
Recruitment Status : Active, not recruiting
First Posted : May 11, 2012
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Yelena Bogdanova, PhD, 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).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Cognitive Dysfunction Blast Injury Device: Repetitive Transcranial Magnetic Stimulation (rTMS), MagStim Behavioral: Cognitive Intervention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combining Cognitive Treatment With Noninvasive Brain Stimulation in Blast TBI
Study Start Date : May 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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), 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



Primary Outcome Measures :
  1. Cognitive Functioning [ Time Frame: Ten Weeks ]

Secondary Outcome Measures :
  1. Daily Functioning [ Time Frame: Ten weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596569


Locations
United States, Massachusetts
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston Medical Center
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Yelena Bogdanova, PhD, PhD Boston University

Publications:
Responsible Party: Yelena Bogdanova, PhD, BUMC Faculty, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01596569     History of Changes
Other Study ID Numbers: CCST
UL1RR025771 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Cognitive Dysfunction
Blast Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Barotrauma