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

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ClinicalTrials.gov Identifier: NCT00714571
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer's Disease Traumatic Brain Injury Behavioral: Mnemonic strategy training (MST) Behavioral: Repeated exposure (XP) Behavioral: Subtracting Cues training Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Behavioral and Neuroimaging Changes After Cognitive Rehab in TBI and MCI
Study Start Date : July 2008
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
XP healthy older adults Stage 1
 Behavioral: Repeated exposure (XP)
Active Comparator: XP MCI Stage 1
XP MCI Stage 1
 Behavioral: Repeated exposure (XP)
Active Comparator: MST healthy older adults Stage 2
MST healthy older adults Stage 2
 Behavioral: Mnemonic strategy training (MST)
Active Comparator: SCT healthy older adults Stage 2
SCT healthy older adults Stage 2
 Behavioral: Subtracting Cues training


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714571


Locations
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United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
VA Office of Research and Development
Emory University
Investigators
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Principal Investigator: Benjamin M. Hampstead, PhD VA Ann Arbor Healthcare System, Ann Arbor, MI
More Information
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Publications of Results:

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00714571    
Other Study ID Numbers: B6366-W
First Posted: July 14, 2008    Key Record Dates
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017
Last Verified: November 2016
Keywords provided by VA Office of Research and Development:
cognitive rehabilitation
explicit memory training
mild cognitive impairment
 Alzheimer's disease
traumatic brain injury
veterans
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Injuries
Brain Injuries, Traumatic
Cognitive Dysfunction
Wounds and Injuries
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System
Cognition Disorders