Non-invasive Brain Stimulation by Transcranial Pulse Stimulation as a Coadjunctive Treatment in Alzheimer's Disease

Study Overview
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Brief Summary
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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 Clínicas, 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 Neurolith™ equipment (Storz Medical, Tagerwillen, Switzerland) will be used to administer transcranial pulse stimulation.

Official Title
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Non-invasive Brain Stimulation by Transcranial Pulse Stimulation as a Coadjunctive Treatment in Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Transcranial pulse stimulation (TPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who have Alzheimer's disease will be selected; Are aged ≥50 years; Medical assistance provided by the psychiatry service at IPQ; Who agree to participate after consent via the Informed Consent Term . Exclusion Criteria: Make regular use of anticoagulants; Has skullcap failure, craniectomy without cranioplasty; Have a diagnosis of brain neoplasms or any type of nodule in the brain region; Have recent brain bleeds or a diagnosis of cerebral arteriovenous malformation; Be diagnosed with a type of dementia other than Alzheimer's; Have Mild Cognitive Impairment of the Elderly (MCI); Have clinical changes that put the test at risk, such as severe cardiorespiratory disorders; Has a severe cognitive disorder that makes it impossible to apply therapy or questionnaires; It is clinically or socially impossible for the patient to attend IMREA for applications twice a week during the study period; Those who disagree to participate after consent via the Informed Consent Term .

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Experimental: Neuronavigation system guided halocranial application of focused sound wave pulses, using the Storz Neurolith™ equipment. | Other: Transcranial pulse stimulation (TPS)<br>* 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 Neurolith™ equipment.<br>|
| Active Comparator: Active Comparator<br>Neuronavigation system guided halocranial application without sound waves pulses, using the Storz Neurolith™ sham equipment, prepared to block the sound waves. | Other: Transcranial pulse stimulation (TPS)<br>* 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 Neurolith™ equipment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease, Transcranial Magnetic Stimulation, Extracorporeal Shockwave Therapy