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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05762926
• Other study ID #: CAAE 54939622.1.0000.0068
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: May 2, 2024

Study information

• Verified date: July 2022
• Source: University of Sao Paulo General Hospital
• Contact: Marta Imamura, MD PhD
• Phone: 55-11-5180-7897
• Email: marta.imamura[@]fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• Transcranial pulse stimulation (TPS)
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.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Functions	Cognitive functions, using Alzheimer's Disease Assessment Scale (ADAS-Cog)	Baseline and up to one, three, six and twelve months from intervention