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This is a randomized, double-blind, placebo-controlled clinical trial; that will evaluate the effectiveness of the use of transcranial pulse stimulation in people living with Alzheimer's disease, coming from the Institute of Psychiatry (IPQ) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo, and the Institute of Physical Medicine and Rehabilitation (IMREA) at the Hospital das ClÃnicas, Faculty of Medicine, University of São Paulo.
Participants will be classified according to the stage of Alzheimer's disease, determined by a psychiatrist and neuropsychologists. A total of 50 volunteers will be randomized blindly. In addition to evaluating the clinical course and imaging examination, the use of scales that assess functional and cognitive disability will be used for the recruitment of volunteers. Volunteers will be randomized into two study groups, and will receive the intervention that will consist of ten sessions, held twice a week. The Storz Neurolithâ„¢ equipment (Storz Medical, Tagerwillen, Switzerland) will be used to administer transcranial pulse stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Experimental: Neuronavigation system guided halocranial application of focused sound wave pulses, using the Storz Neurolithâ„¢ equipment. |
|
| Active Comparator | Active Comparator | Neuronavigation system guided halocranial application without sound waves pulses, using the Storz Neurolithâ„¢ sham equipment, prepared to block the sound waves. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial pulse stimulation (TPS) | Other | Clinical treatment consists in ten sessions of neuronavigation system guided halocranial application of 6000 focused sound wave pulses, with energy flux density of 0.25 mJ/mm2, depth of focus of 5 cm and useful energy between 4 to 6 cm, frequency of 4 Hz, total energy applied will be 50 Joules, for it will be used the Storz Neurolithâ„¢ equipment. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Functions | Cognitive functions, using Alzheimer's Disease Assessment Scale (ADAS-Cog) | Baseline and up to one, three, six and twelve months from intervention |
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Inclusion Criteria:
Exclusion Criteria:
50 Years and older (Adult, Older Adult)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Imamura, MD PhD | Contact | 55-11-5180-7897 | marta.imamura@fm.usp.br | |
| Artur Santos | Contact | 55-11-3905-8414 | artur.santos@hc.fm.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Marta Imamura, MD PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina FÃsica e Reabilitação, Hospital das ClÃnicas, Faculdade de Medicina da Universidade de São Paulo | São Paulo | São Paulo | 04116-030 | Brazil |
Individual Participant Data (IPD) may be shared in the future under suitable request and justification to principal investigator.
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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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Parallel Assignment
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Double (Care Provider, Outcomes Assessor)
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |