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Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve cognition in Alzheimer's disease (AD) with conflicting results. In this study we aimed to explore feasibility, safety and efficacy of excitatory rTMS of bilateral DLPFC applied with H-coil in AD in a pilot randomized, placebo-controlled, double-blind study.
Study Design The study was a double-blind, placebo-controlled paradigm, with randomization into a real rTMS group or a sham rTMS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real rTMS stimulation | Active Comparator | real deep excitatory, high frequency rTMS with H-coil stimulation |
|
| Sham rTMS stimulation | Sham Comparator | sham high frequency H-coil stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS with H-coil | Device | Deep repetitive transcranial manetic stimulation or sham stimulation with H-coil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement at Alzheimer's Disease Assessment Scale-cognitive over time | Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia | Change in the score between Baseline evaluation and end of the treatment (2 months after start of the treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement at Mini Mental State Examination scale over time | Neuropsychological test used to assess the intellectual efficiency disorders and the presence of cognitive impairment | Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giancarlo Comi, MD | IRCCS San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Milan | MI | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33679572 | Derived | Leocani L, Dalla Costa G, Coppi E, Santangelo R, Pisa M, Ferrari L, Bernasconi MP, Falautano M, Zangen A, Magnani G, Comi G. Repetitive Transcranial Magnetic Stimulation With H-Coil in Alzheimer's Disease: A Double-Blind, Placebo-Controlled Pilot Study. Front Neurol. 2021 Feb 18;11:614351. doi: 10.3389/fneur.2020.614351. eCollection 2020. |
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all IPD that underlie results in a publication
starting 6 months after publication
data are available from the corresponding author, upon reasonable request.
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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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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Sham rTMS stimulation with H-coil | Device | Sham rTMS stimulation |
|
| Improvement at Beck Depression Inventory scale-II over time | Self-report inventory, psychometric test used to assess the severity of depression | Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment) |
| Improvement at Clinical Global Impression-Improvement scale over time | Scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention | Baseline evaluation, 1 month after start of the treatment, end of the treatment (2 months after start of the treatment) and end of follow-up (4 months after start of the treatment) |
| Persistence of improvement at Alzheimer's Disease Assessment Scale-cognitive over time | Brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia | Change in the score between end of treatment (2 months after start of the treatment) and end of follow-up (4 months after start of treatment) |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |