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| Name | Class |
|---|---|
| Emory University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MST healthy older adults Stage 1 | Active Comparator | Mnemonic strategy training |
|
| MST MCI Stage 1 | Active Comparator | Exposure training |
|
| XP healthy older adults Stage 1 | Active Comparator | XP healthy older adults Stage 1 |
|
| XP MCI Stage 1 | Active Comparator | XP MCI Stage 1 |
|
| MST healthy older adults Stage 2 | Active Comparator | MST healthy older adults Stage 2 |
|
| SCT healthy older adults Stage 2 | Active Comparator | SCT healthy older adults Stage 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mnemonic strategy training (MST) | Behavioral |
| ||
| 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 |
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Inclusion Criteria:
General inclusion criteria (all patients):
MCI Inclusion Criteria:
TBI Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin M. Hampstead, PhD | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur | Decatur | Georgia | 30033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22409311 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MST Healthy Older Adults: Stage 1 | Mnemonic strategy training for object location associations for healthy older adults |
| FG001 | MST MCI: Stage 1 | Mnemonic strategy training for object location associations in patients with MCI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 |
|
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|
| Repeated exposure (XP) |
| Behavioral |
|
| Subtracting Cues training | Behavioral |
|
| FG002 | XP Healthy Older Adults: Stage 1 | Repeated exposure for object location associations in healthy older adults |
| FG003 | XP MCI: Stage 1 | Repeated exposure for object location associations in patients with MCI |
| FG004 | MST Healthy Older Adults: Stage 2 | Mnemonic strategy training for face name associations in healthy older adults |
| FG005 | SCT Healthy Older Adults: Stage 2 | Subtracting cues training for face name associations in healthy older adults |
| COMPLETED |
|
| NOT COMPLETED |
|
| Stage 2 |
|
One participant from MST Healthy older adults Stage 1 excluded after study completion due to ongoing chemotherapy treatment (undisclosed during study).
One participant from MST MCI Stage 1 excluded due to being diagnosed with Alzheimer's dementia within 1 month of completing study
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| ID | Title | Description |
|---|---|---|
| BG000 | MST Healthy Older Adults: Stage 1 | Mnemonic strategy training for object location associations for healthy older adults |
| BG001 | MST MCI: Stage 1 | Mnemonic strategy training for object location associations in patients with MCI |
| BG002 | XP Healthy Older Adults: Stage 1 | Repeated exposure for object location associations in healthy older adults |
| BG003 | XP MCI: Stage 1 | Repeated exposure for object location associations in patients with MCI |
| BG004 | MST Healthy Older Adults: Stage 2 | Mnemonic strategy training for face name associations in healthy older adults |
| BG005 | SCT Healthy Older Adults: Stage 2 | Subtracting cues training for face name associations in healthy older adults |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Memory Test Accuracy on Trained Stimuli | Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test | MST older adults Stage 1: 1 participant excluded due to undisclosed ongoing chemotherapy treatment XP older adults Stage 1: 1 participant decided not to participate after randomization MST MCI Stage 1: 1 participant diagnosed with Alzheimer's dementia within 1 month of completing study | Posted | Mean | Standard Deviation | Percent correct | Pre-training, post-training, 1 month |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MST Healthy Older Adults: Stage 1 | Mnemonic strategy training for object location associations for healthy older adults | 0 | 12 | 0 | 12 | ||
| EG001 | MST MCI: Stage 1 | Mnemonic strategy training for object location associations in patients with MCI | 0 | 15 | 0 | 15 | ||
| EG002 | XP Healthy Older Adults: Stage 1 | Repeated exposure for object location associations in healthy older adults | 0 | 11 | 0 | 11 | ||
| EG003 | XP MCI: Stage 1 | Repeated exposure for object location associations in patients with MCI | 0 | 14 | 0 | 14 | ||
| EG004 | MST Healthy Older Adults: Stage 2 | Mnemonic strategy training for face name associations in healthy older adults | 0 | 15 | 0 | 15 | ||
| EG005 | SCT Healthy Older Adults: Stage 2 | Subtracting cues training for face name associations in healthy older adults | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin M. Hampstead | VA Ann Arbor Healthcare System | 734-763-9259 | Benjamin.Hampstead@va.gov |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| Male |
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| Post-Training |
|
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| 1-month |
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|