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

Alzheimer Disease

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

Inclusion Criteria4

age\>18 years
diagnosis of early dementia according to current international guidelines
disease duration of at least 12 months
consent to participate in the study.

Exclusion Criteria4

medical instability interfering with standard neurological assessment
any contraindication to preliminary MRI for MR-based real-time neuronavigation
comorbidities which may interfere with cognitive status
any contraindication to Transcranial Pulse Stimulation.

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.