Transcranial Pulse Stimulation. a Potential Treatment for Early Dementia

NCT06730438 | Recruiting

• 1 other identifier: PNRR-MCNT2-2023-12377235
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; Transcranial Pulse Stimulation; Dementia

Outcome Measures

Primary Outcomes (1)

• Cognitive improvement

  Cognitive improvement as evaluated by means of the ADAS-Cog, scores range from 0, that means the absence of cognitive dysfunctions, to a maximum of 70, that indicates a serious deficit in all tests.

  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); 6 months following the start of TPS (t4).

Study Arms (2)

Transcranial pulse stimulation

EXPERIMENTAL

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

Device: Transcranial Pulse Stimulation

Sham stimulation Group

SHAM COMPARATOR

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

Device: Transcranial Pulse Stimulation

Interventions

Transcranial Pulse Stimulation DEVICE

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.

Sham stimulation Group; Transcranial pulse stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francesca Pistoia: lead

Study Sites (2)

San Salvatore Hospital

L’Aquila, Italy, 67100, Italy

RECRUITING

San Salvatore Hospital

L’Aquila, Italy, 67100, Italy

RECRUITING

Related Publications (2)

• Matt E, Kaindl L, Tenk S, Egger A, Kolarova T, Karahasanovic N, Amini A, Arslan A, Saricicek K, Weber A, Beisteiner R. First evidence of long-term effects of transcranial pulse stimulation (TPS) on the human brain. J Transl Med. 2022 Jan 15;20(1):26. doi: 10.1186/s12967-021-03222-5.

  PMID: 35033118 BACKGROUND

• Beisteiner R, Matt E, Fan C, Baldysiak H, Schonfeld M, Philippi Novak T, Amini A, Aslan T, Reinecke R, Lehrner J, Weber A, Reime U, Goldenstedt C, Marlinghaus E, Hallett M, Lohse-Busch H. Transcranial Pulse Stimulation with Ultrasound in Alzheimer's Disease-A New Navigated Focal Brain Therapy. Adv Sci (Weinh). 2019 Dec 23;7(3):1902583. doi: 10.1002/advs.201902583. eCollection 2020 Feb.

  PMID: 32042569 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Francesca Pistoia, MD, PhD

CONTACT

+39862368657; francesca.pistoia@univaq.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: Double Blind Sham-Controlled Study

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)