Clinical trial NCT00714571: Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI)
Official title: Behavioral and Neuroimaging Changes After Cognitive Rehab in TBI and MCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Traumatic Brain Injury
Keywords: cognitive rehabilitation
explicit memory training
mild cognitive impairment
Alzheimer's disease
traumatic brain injury
veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Emory University
First posted: 2008-07-14
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Memory Test Accuracy on Trained Stimuli
timeFrame: Pre-training, post-training, 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur
state: Georgia
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Benjamin M. Hampstead, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hampstead BM, Sathian K, Phillips PA, Amaraneni A, Delaune WR, Stringer AY. Mnemonic strategy training improves memory for object location associations in both healthy elderly and patients with amnestic mild cognitive impairment: a randomized, single-blind study. Neuropsychology. 2012 May;26(3):385-99. doi: 10.1037/a0027545. Epub 2012 Mar 12.