Transcranial Pulse Stimulation. a Potential Treatment for Early Dementia
NCT ID: NCT06730438
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-12-31
2026-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Transcranial pulse stimulation
Patients belonging to this group will receive real transcranial pulse stimulation over a 4-weeks period, once a day for five days a week.
Transcranial 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.
Sham stimulation Group
Patients belonging to this group will receive sham transcranial pulse stimualtion over a 4-weeks period, once a day for five days a week.
Transcranial 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.
Interventions
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Transcranial 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.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of early dementia according to current international guidelines
* disease duration of at least 12 months
* consent to participate in the study.
Exclusion Criteria
* any contraindication to preliminary MRI for MR-based real-time neuronavigation
* comorbidities which may interfere with cognitive status
* any contraindication to Transcranial Pulse Stimulation.
18 Years
ALL
No
Sponsors
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Francesca Pistoia
OTHER
Responsible Party
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Francesca Pistoia
Associate Professor of Neurology
Locations
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San Salvatore Hospital
L’Aquila, Italy, Italy
San Salvatore Hospital
L’Aquila, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Francesca Pistoia, MD, PhD
Role: primary
Francesca Pistoia, MD, PhD
Role: primary
Francesca Pistoia, MD, PhD
Role: backup
References
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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.
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.
Other Identifiers
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PNRR-MCNT2-2023-12377235
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PNRR-MCNT2-2023-12377235
Identifier Type: -
Identifier Source: org_study_id