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Difficulty with recruitment due to Covid. 3 subjects consented but did not start any study procedures or participate in the study.
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This is a randomized sham control study to evaluate how repetitive Transcranial Magnetic Stimulation (rTMS), interactive cognitive training, or the combination of rTMS and cognitive training reduce the cognitive decline of patients diagnosed with Alzheimer's disease
Participants may be assigned to one of four experimental arms (1-TMS-Stimulation with X-Torp task, 2-TMS-Stimulation with MindMotion Go, 3-TMS-Sham with X-Torp task, 4-TMS-Sham with MindMotion Go.) The study will be conducted in two phases. During Phase 1, participants will be randomized between experimental conditions 1 and 4. Data will be analyzed upon completion of Phase1 and Phase 2 will commence only if there is efficacy in the TMS arm. During Phase2, participants will be randomized to arms 2 and 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS-Stimulation with X-Torp task | Experimental | TMS with VR 1 experimental arm |
|
| TMS-Stimulation with MindMotion Go | Experimental | TMS with VR 2 experimental arm |
|
| TMS-Sham with X-Torp task | Sham Comparator | TMS sham control with VR 1 |
|
| TMS-Sham with MindMotion Go | Sham Comparator | TMS sham control with sham VR 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS stimulation with X-Torp task | Device | TMS-Stimulation with X-Torp task |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Performance | Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30) | 6 months after completion study procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Brain MRI | Change in brain structure and function over time | 6 months after completion of study procedure compared to screening |
| Memory Performance | Total recall on the California Verbal Learning Test - short form (range 0-36) |
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Inclusion Criteria:
Male or Female between 50-85 years of age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Haut, PhD | Rockefeller Neuroscience Institute | Study Chair |
| Victor Finomore, PhD | Rockefeller Neuroscience Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University Rockefeller Neuroscience Institute | Morgantown | West Virginia | 26506 | United States |
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| TMS-Stimulation with MindMotion Go | Device | TMS-Stimulation with MindMotion Go |
|
| TMS-Sham with X-Torp task | Device | TMS-Sham with X-Torp task |
|
| TMS-Sham with MindMotion Go | Device | TMS-Sham with MindMotion Go |
|
| 6 months after completion of study procedure compared to screening |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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