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

Mild Cognitive Impairment Clinical Trial

Official title:

Behavioral and Neuroimaging Changes After Cognitive Rehab in TBI and MCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714571
• Other study ID #: B6366-W
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2008
• Last updated: October 7, 2014
• Start date: July 2008
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Brain Injuries
• Cognition Disorders
• Mild Cognitive Impairment
• Traumatic Brain Injury

Intervention

Behavioral:
• explicit memory training
Participants receive training in various cognitive rehabilitation techniques designed to facilitate learning and memory.
• implicit memory training
Participants receive training in various cognitive rehabilitation techniques designed to facilitate learning and memory.

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral performances (accuracy & reaction time) on experimental stimuli. fMRI correlates of behavioral change.		Post training efficacy assessed within 2 weeks of start & 1 month post-completion of study.	No