Phase 1 N=52 Randomized Single-blind Treatment

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

Mild Cognitive Impairment · Alzheimer's Disease · Traumatic Brain Injury

Bottom Line

View on ClinicalTrials.gov: NCT00714571 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: Memory Test Accuracy on Trained Stimuli — 53.9; 37.6; 48.9; 37.3 Percent correct

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Mnemonic strategy training (MST) (Behavioral); Repeated exposure (XP) (Behavioral); Subtracting Cues training (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Memory Test Accuracy on Trained Stimuli	53.9; 37.6; 48.9; 37.3; 59.8; 57.6	—

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.

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00714571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.