NCT01138020

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
14.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

14.3 years

First QC Date

June 3, 2010

Last Update Submit

April 10, 2026

Conditions

Keywords

Rehabilitation OutcomeCognitive treatmentTBI

Outcome Measures

Primary Outcomes (1)

  • Cognitive functioning

    Scaled Score on the standardized neuropsychological testing

    Ten weeks

Secondary Outcomes (1)

  • Daily functioning

    Ten weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Cognitive intervention

Behavioral: Cognitive Intervention

Arm 2

ACTIVE COMPARATOR

Educational intervention

Behavioral: Educational intervention

Interventions

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

Arm 1

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

Arm 2

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Evidence of penetrating head injury
  • History of previous neurological diagnosis
  • History of previous psychotic disorder prior to the blast exposure
  • Hearing or vision impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02130-4817, United States

Location

Related Publications (3)

  • 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.

    PMID: 22350691BACKGROUND
  • Gilbert KS, Kark SM, Gehrman P, Bogdanova Y. Sleep disturbances, TBI and PTSD: Implications for treatment and recovery. Clin Psychol Rev. 2015 Aug;40:195-212. doi: 10.1016/j.cpr.2015.05.008. Epub 2015 Jun 3.

  • Bogdanova Y, Yee MK, Ho VT, Cicerone KD. Computerized Cognitive Rehabilitation of Attention and Executive Function in Acquired Brain Injury: A Systematic Review. J Head Trauma Rehabil. 2016 Nov/Dec;31(6):419-433. doi: 10.1097/HTR.0000000000000203.

MeSH Terms

Conditions

Brain Injuries, TraumaticNeurobehavioral Manifestations

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Yelena Bogdanova, PhD PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2010

First Posted

June 7, 2010

Study Start

March 1, 2011

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations