We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01138020
First Posted: June 7, 2010
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
June 3, 2010
June 7, 2010
August 24, 2017
March 1, 2011
October 31, 2017   (Final data collection date for primary outcome measure)
Cognitive functioning [ Time Frame: Ten weeks ]
Scaled Score on the standardized neuropsychological testing
Cognitive functioning [ Time Frame: Ten weeks ]
Complete list of historical versions of study NCT01138020 on ClinicalTrials.gov Archive Site
Daily functioning [ Time Frame: Ten weeks ]
Total Score on the daily functioning measure
Daily functioning [ Time Frame: Ten weeks ]
Not Provided
Not Provided
 
Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)
Cognitive Rehabilitation of Blast-induced Traumatic Brain Injury
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).
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Traumatic Brain Injury
  • Cognitive Symptoms
  • Behavioral: Cognitive Intervention
    Cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function
  • Behavioral: Educational intervention
    Educational intervention is geared at personal management of TBI-related symptoms.
  • Experimental: Arm 1
    Cognitive intervention
    Intervention: Behavioral: Cognitive Intervention
  • Active Comparator: Arm 2
    Educational intervention
    Intervention: Behavioral: Educational intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
October 31, 2018
October 31, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01138020
D6996-W
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
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Yelena Bogdanova, PhD PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
VA Office of Research and Development
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP