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| Name | Class |
|---|---|
| Brainsway | INDUSTRY |
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The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.
Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17).
Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm.
Ages: 50-80 Genders: both
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 15 patients in group 1 will be treated with 1Hz frequency |
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| 2 | Active Comparator | 15 patients in group 2 will be treated with 1Hz frequency 10Hz |
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| 3 | Sham Comparator | 15 patients in group 3 will be treated with SHAM (1Hz/10Hz) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1Hz TMS with H2 coil | Device | 1Hz TMS with H2 coil to prefrontal and parieto-temporal cortex |
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| Measure | Description | Time Frame |
|---|---|---|
| ADAS-COG | Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17) |
| Measure | Description | Time Frame |
|---|---|---|
| CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory. | Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alissa Ash, Dr. | Contact | +972-3-6973698 | elissaa@tasmc.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Alissa Ash, Dr. | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center, Neurology Department | Recruiting | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex |
| Device |
10Hz TMS with H2 coil to prefrontal and parieto-temporal cortex |
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| SHAM TMS with H2 coil | Device | SHAM TMS with H2 coil to prefrontal and parieto-temporal cortex |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |