Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI)

Phase 1

Completed

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment; Traumatic Brain Injury

• Registration Number: NCT00714571
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-14
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-11
• Results First Submitted: 2016-11-03
• Results First Submitted QC: 2016-11-03
• Last Update Submitted: 2016-11-03
• Results First Posted: 2017-01-04
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

TBI Inclusion criteria:

• History of a mild to moderate TBI;
• No history of other neurological disease or injury;
• A minimum of 6 months and maximum of 5 years post-onset of TBI;
• 18 - 45 years old.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Memory Test Accuracy on Trained Stimuli	Pre-training, post-training, 1 month	Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test

Trial Locations

Locations (1)

Atlanta VA Medical and Rehab Center, Decatur; 🇺🇸 Decatur, Georgia, United States