RecruitingNot ApplicableNCT06730438

Transcranial Pulse Stimulation. a Potential Treatment for Early Dementia

Transcranial Pulse Stimulation: a Potential New Treatment for Chronic Disorders of Consciousness/Cognition Due to Vegetative/Minimally Conscious States and Early Dementia


Sponsor

Francesca Pistoia

Enrollment

100 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Alzheimer's Disease (AD) is characterized by the absence of treatments to slow, stop, or reverse its course, with patients finally losing cognitive functions, skills and independence. It is a chronic degenerative disease with high social and medical burden worldwide: AD ranked third among neurological disorders in terms of disability-adjusted life years (DALY) rates. The primary aim of the research protocol is to improve care for patients with AD, by implementing, with an innovative method, the currently available repertoire of neuromodulation techniques. For this aim, we will investigate whether Transcranial Pulse Stimulation (TPS) may induce cognitive improvement in patients with an early stage of dementia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing transcranial pulse stimulation (TPS) — a non-invasive brain stimulation technique — as a potential treatment for people in the early stages of dementia. The device delivers gentle sound waves to targeted areas of the brain to see if it can slow or improve cognitive decline. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with early dementia according to current medical guidelines - You have had the diagnosis for at least 12 months - You are willing and able to give your consent to participate **You may NOT be eligible if...** - You are medically unstable in a way that would interfere with standard neurological testing - You have a condition that prevents you from having an MRI scan - You have other health conditions that affect your thinking or memory - You have any condition that makes brain stimulation unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscranial Pulse Stimulation

Patients will receive TPS once a day for five days a week, each session will be separated from the previous one by 24h. Each stimulation and assessment session will be performed at the same hour of the day, in the morning preferably, to maximize the probability of observing responses to stimuli. Patients will be managed in a quiete room with stable light and temperature.


Locations(2)

San Salvatore Hospital

L’Aquila, Italy, Italy

San Salvatore Hospital

L’Aquila, Italy, Italy

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NCT06730438


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