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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

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

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

NCT ID

NCT00714571

First Posted

July 8, 2008

Last Updated

November 3, 2016

Sponsor

VA Office of Research and Development

Collaborators

Emory University

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

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

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

result

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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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