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

Behavioral and Neuroimaging Changes After Cognitive Rehab in TBI and MCI

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Mild Cognitive Impairment; Alzheimer's Disease
• Intervention / Treatment: Behavioral: Mnemonic strategy training (MST); Behavioral: Repeated exposure (XP); Behavioral: Subtracting Cues training

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta VA Medical and Rehab Center, Decatur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MST healthy older adults Stage 1; Mnemonic strategy training	Behavioral: Mnemonic strategy training (MST)
Active Comparator: MST MCI Stage 1; Exposure training	Behavioral: Mnemonic strategy training (MST)
Active Comparator: XP healthy older adults Stage 1	Behavioral: Repeated exposure (XP)
Active Comparator: XP MCI Stage 1	Behavioral: Repeated exposure (XP)
Active Comparator: MST healthy older adults Stage 2	Behavioral: Mnemonic strategy training (MST)
Active Comparator: SCT healthy older adults Stage 2	Behavioral: Subtracting Cues training

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Emory University
• Investigators: Principal Investigator: Benjamin M. Hampstead, PhD, VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 8, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Alzheimer's disease; cognitive rehabilitation; explicit memory training; mild cognitive impairment; traumatic brain injury; veterans
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurocognitive Disorders; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Dementia; Tauopathies; Cognition Disorders; Brain Injuries; Brain Injuries, Traumatic; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: B6366-W

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No