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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01138020
First received: June 3, 2010
Last updated: May 4, 2016
Last verified: May 2016

June 3, 2010
May 4, 2016
March 2011
March 2017   (final data collection date for primary outcome measure)
Cognitive functioning [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01138020 on ClinicalTrials.gov Archive Site
Daily functioning [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
Same as current
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
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
September 2017
March 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
Both
21 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01138020
D6996-W
No
Not Provided
Not Provided
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
May 2016

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