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Clinical Trials/NCT00714571
NCT00714571
Completed
Phase 1

Behavioral and Neuroimaging Changes After Cognitive Rehab in TBI and MCI

VA Office of Research and Development1 site in 1 country82 target enrollmentJuly 2008

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
VA Office of Research and Development
Enrollment
82
Locations
1
Primary Endpoint
Memory Test Accuracy on Trained Stimuli
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Memory deficits are common after traumatic brain injuries (TBI) and are characteristic of various forms of dementia, such as Alzheimer's disease and its common precursor mild cognitive impairment (MCI). This project intends to assess the efficacy of cognitive rehabilitation in these patient populations. We will also use neuroimaging (functional magnetic resonance imaging - fMRI) to assess changes in brain activity that occur following cognitive rehabilitation.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
September 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • General inclusion criteria (all patients):
  • A minimum of 12 years of education or attainment of a Graduation Equivalency Diploma;
  • All medications stable for approximately 3 months;
  • No history of severe mental illness;
  • No current untreated alcohol or substance abuse/dependence;
  • English as native and preferred language;
  • MRI-compatible if taking part in fMRI studies 7) Able to give informed consent.
  • MCI Inclusion Criteria:
  • Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician;
  • 55 years of age or older.

Exclusion Criteria

  • History of neurological disease or injury (other than TBI)
  • History of severe mental illness
  • Current untreated alcohol or substance abuse
  • Other conditions may exclude; please discuss with contact

Outcomes

Primary Outcomes

Memory Test Accuracy on Trained Stimuli

Time Frame: Pre-training, post-training, 1 month

Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test

Study Sites (1)

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