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

NCT05762926 | Unknown

• 1 other identifier: CAAE 54939622.1.0000.0068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; Transcranial Magnetic Stimulation; Extracorporeal Shockwave Therapy

Outcome Measures

Primary Outcomes (1)

• Cognitive Functions

  Cognitive functions, using Alzheimer's Disease Assessment Scale (ADAS-Cog)

  Baseline and up to one, three, six and twelve months from intervention

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental: Neuronavigation system guided halocranial application of focused sound wave pulses, using the Storz Neurolith™ equipment.

Other: Transcranial pulse stimulation (TPS)

Active Comparator

ACTIVE COMPARATOR

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)

Interventions

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 Neurolith™ equipment.

Active Comparator; Experimental

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: 50 Years and older (Adult, Older Adult)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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 .

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 04116-030, Brazil

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Marta Imamura, MD PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double (Care Provider, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: March 10, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: May 2, 2024
• Last Updated: April 18, 2023

Record last verified: 2022-07

Locations

BR (1)