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OpenTrials
Completed

NCT Number: NCT01138020

Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)

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).

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive intervention

Behavioral

Cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function

Educational intervention

Behavioral

Educational intervention is geared at personal management of TBI-related symptoms.

Primary outcomes

  1. Cognitive functioning

    Time frame: Ten weeks

    Scaled Score on the standardized neuropsychological testing

Secondary outcomes

  1. Daily functioning

    Time frame: Ten weeks

    Total Score on the daily functioning measure

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Cognitive Rehabilitation of Blast-induced Traumatic Brain Injury

Acronym: CRbTBI

Important dates

Study start
2011
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2010
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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