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Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI) (CRbTBI)

This study is currently recruiting participants.
Verified February 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01138020
First received: June 3, 2010
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to investigate the efficacy of a structured rehabilitation program on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).


Condition Intervention Phase
Traumatic Brain Injury
Cognitive Symptoms
 Behavioral: Cognitive Intervention
Behavioral: Educational intervention
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation of Blast-induced Traumatic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

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: 120
Study Start Date: March 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Cognitive intervention
 Behavioral: Cognitive Intervention
Cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function
Active Comparator: Arm 2
Educational intervention
 Behavioral: Educational intervention
Educational intervention is geared at personal management of TBI-related symptoms.

Detailed Description:

The most common impairments following blast-induced traumatic brain injury (bTBI) are cognitive deficits in the domain of executive functioning, learning and memory, and functional and psychosocial disabilities that are closely related to these cognitive deficits. There are no treatment protocols available to address the multiple cognitive impairments in bTBI, but cognitive rehabilitation has proven efficacious in the treatment of non-blast TBI. The cognitive training modules we plan to evaluate have improved organization and memory function in patients with non-blast TBI, but it is unknown whether their efficacy exceeds that of programs that focus only on education and support. This study is a between group comparison of a cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function, and an active control group receiving educational intervention geared at personal management of TBI-related symptoms.

  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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138020

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

Locations
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus Recruiting
Boston, Massachusetts, United States, 02130
Contact: Yelena Bogdanova, PhD     857-364-2249     bogdanov@bu.edu    
Principal Investigator: Yelena Bogdanova, PhD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Yelena Bogdanova, PhD VA Medical Center, Jamaica Plain Campus
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01138020     History of Changes
Other Study ID Numbers: D6996-W
Study First Received: June 3, 2010
Last Updated: February 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Rehabilitation Outcome
Cognitive treatment
TBI

Additional relevant MeSH terms:
Brain Injuries
Neurobehavioral Manifestations
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013