Transcranial Pulse Stimulation. a Potential Treatment for Early Dementia

Francesca Pistoia

Status: Enrolling

Conditions: Alzheimer Disease

Treatments: Device: Transcranial Pulse Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06730438

PNRR-MCNT2-2023-12377235 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Aims of the project: The primary aim of our research protocol is to improve care for patients with AD by investigating whether Transcranial Pulse Stimulation (TPS) may induce cognitive improvement in patients with an early stage of dementia. Additional aims will include the investigation of the neurophysiological profile of patients and the search for a correlation between neuropsychological and neurophysiological data with the serum levels of brain-derived neurotrophic factor (BDNF) and of vascular endothelial growth factor (VEGF).

Materials and Methods: Following a rigorous selection, included patients will be treated through a real/sham structured TPS protocol and followed-up with respect to cognitive improvement, by comparing baseline and follow-up clinical scores. A Double Blind Sham-Controlled Study will be performed: patients will be assigned randomly to receive TPS or sham TPS for 4 weeks in a parallel groups, double-blind study. Patients will receive ether TPS or sham treatment once a day for five days a week for the whole period and will be assessed according to the following schedule: baseline (t0); at two weeks following the start of TPS (t1); at 1 month following the start of TPS (t2); at 2 months following the start of TPS (t3); at 6 months following the start of TPS (t4). Electroencephalography (EEG) and Somatory Evoked Potentials (SEP) will be contextually recorded in all patients, to compare neurophysiological data of patients treated with real TPS and sham stimulation. Moreover, a serum sample will be collected from patients at baseline, at the end of the stimulation period and at the 6-month follow-up, to compare preprocedural and postprocedural levels of serum BDNF and VEGF.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Transcranial pulse stimulation

Experimental group

Description:

Patients belonging to this group will receive real transcranial pulse stimulation over a 4-weeks period, once a day for five days a week.

Treatment:

Device: Transcranial Pulse Stimulation

Sham stimulation Group

Sham Comparator group

Description:

Patients belonging to this group will receive sham transcranial pulse stimualtion over a 4-weeks period, once a day for five days a week.

Treatment:

Device: Transcranial Pulse Stimulation