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

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ClinicalTrials.gov Identifier: NCT01138020
Recruitment Status : Active, not recruiting
First Posted : June 7, 2010
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Traumatic Brain Injury Cognitive Symptoms Behavioral: Cognitive Intervention Behavioral: Educational intervention Not Applicable

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 the investigators 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation of Blast-induced Traumatic Brain Injury
Actual Study Start Date : March 1, 2011
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Cognitive functioning [ Time Frame: Ten weeks ]
    Scaled Score on the standardized neuropsychological testing


Secondary Outcome Measures :
  1. Daily functioning [ Time Frame: Ten weeks ]
    Total Score on the daily functioning measure



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:

  • Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) active-duty personnel or Veterans exposed to blast
  • Meets criteria for mild TBI
  • loss of consciousness (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

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): NCT01138020


Locations
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Yelena Bogdanova, PhD PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01138020     History of Changes
Other Study ID Numbers: D6996-W
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Rehabilitation Outcome
Cognitive treatment
TBI

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