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

Primary Purpose

Mild Cognitive Impairment, Alzheimer's Disease, Traumatic Brain Injury

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mnemonic strategy training (MST)
Repeated exposure (XP)
Subtracting Cues training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring cognitive rehabilitation, explicit memory training, mild cognitive impairment, Alzheimer's disease, traumatic brain injury, veterans

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

MST healthy older adults Stage 1

MST MCI Stage 1

XP healthy older adults Stage 1

XP MCI Stage 1

MST healthy older adults Stage 2

SCT healthy older adults Stage 2

Arm Description

Mnemonic strategy training

Exposure training

XP healthy older adults Stage 1

XP MCI Stage 1

MST healthy older adults Stage 2

SCT healthy older adults Stage 2

Outcomes

Primary Outcome Measures

Memory Test Accuracy on Trained Stimuli
Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test

Secondary Outcome Measures

Full Information

First Posted
July 8, 2008
Last Updated
November 3, 2016
Sponsor
VA Office of Research and Development
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00714571
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MST healthy older adults Stage 1
Arm Type
Active Comparator
Arm Description
Mnemonic strategy training
Arm Title
MST MCI Stage 1
Arm Type
Active Comparator
Arm Description
Exposure training
Arm Title
XP healthy older adults Stage 1
Arm Type
Active Comparator
Arm Description
XP healthy older adults Stage 1
Arm Title
XP MCI Stage 1
Arm Type
Active Comparator
Arm Description
XP MCI Stage 1
Arm Title
MST healthy older adults Stage 2
Arm Type
Active Comparator
Arm Description
MST healthy older adults Stage 2
Arm Title
SCT healthy older adults Stage 2
Arm Type
Active Comparator
Arm Description
SCT healthy older adults Stage 2
Intervention Type
Behavioral
Intervention Name(s)
Mnemonic strategy training (MST)
Intervention Type
Behavioral
Intervention Name(s)
Repeated exposure (XP)
Intervention Type
Behavioral
Intervention Name(s)
Subtracting Cues training
Primary Outcome Measure Information:
Title
Memory Test Accuracy on Trained Stimuli
Description
Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test
Time Frame
Pre-training, post-training, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin M. Hampstead, PhD
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22409311
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.
Results Reference
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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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