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

Not Applicable

• Conditions: Alzheimer Disease
• Interventions: Other: Transcranial pulse stimulation (TPS)

• Registration Number: NCT05762926
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-10
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-18
• Study Start: 2023-08-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-05-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Transcranial pulse stimulation (TPS)	Experimental: Neuronavigation system guided halocranial application of focused sound wave pulses, using the Storz Neurolith™ equipment.
Active Comparator	Transcranial pulse stimulation (TPS)	Neuronavigation system guided halocranial application without sound waves pulses, using the Storz Neurolith™ sham equipment, prepared to block the sound waves.

Primary Outcome Measures

Name	Time	Method
Cognitive Functions	Baseline and up to one, three, six and twelve months from intervention	Cognitive functions, using Alzheimer's Disease Assessment Scale (ADAS-Cog)

Trial Locations

Locations (1)

Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil