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

NCT00714571 | Completed Phase 1 Results

• 1 other identifier: B6366-W
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

MST healthy older adults Stage 1

ACTIVE COMPARATOR

Mnemonic strategy training

Behavioral: Mnemonic strategy training (MST)

MST MCI Stage 1

ACTIVE COMPARATOR

Exposure training

Behavioral: Mnemonic strategy training (MST)

XP healthy older adults Stage 1

ACTIVE COMPARATOR

XP healthy older adults Stage 1

Behavioral: Repeated exposure (XP)

XP MCI Stage 1

ACTIVE COMPARATOR

XP MCI Stage 1

Behavioral: Repeated exposure (XP)

MST healthy older adults Stage 2

ACTIVE COMPARATOR

MST healthy older adults Stage 2

Behavioral: Mnemonic strategy training (MST)

SCT healthy older adults Stage 2

ACTIVE COMPARATOR

SCT healthy older adults Stage 2

Behavioral: Subtracting Cues training

Interventions

Mnemonic strategy training (MST) BEHAVIORAL

MST MCI Stage 1; MST healthy older adults Stage 1; MST healthy older adults Stage 2

Repeated exposure (XP) BEHAVIORAL

XP MCI Stage 1; XP healthy older adults Stage 1

Subtracting Cues training BEHAVIORAL

SCT healthy older adults Stage 2

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;
• years of age or older.
• 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;
• years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Emory University: collaborator

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

Related Publications (1)

• 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.

  PMID: 22409311 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Benjamin M. Hampstead
• Organization: VA Ann Arbor Healthcare System

Benjamin.Hampstead@va.gov

734-763-9259

Study Officials

• Benjamin M. Hampstead, PhD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 14, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 4, 2017
• Results First Posted: January 4, 2017

Record last verified: 2016-11

Locations

US (1)