NCT07883148Completed
TPSAlz - Transcranial Pulse Stimulation in Alzheimer's Disease
Effects of Transcranial Pulse Stimulation on Functional and Structural Brain Connectivity in Mild Cognitive Impairment and in the Early Stages of Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
The goal of this study is to evaluate the effects of transcranial pulse stimulation (TPS) in modulating cognitive functions as well as structural and functional connectivity in individuals with mild cognitive impairment and early Alzheimer's disease. The main outcome measure is to confirm whether TPS may be considered as an effective treatment to improve memory in a large cohort of participants and investigating its long-term effects. Then, secondary measurements are to evaluate if TPS may induce neuronal connectivity changes and may confirm previous results exploring whether this innovative technique may induce, in a long and short-term period, possible effects on cortical atrophy and structural connectivity. An additional outcomes is to evaluate if TPS may have a positive impact on global cognitive functioning and behavioral profile.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 26 Mar 2025
- Start date
- May 2024
- Primary completion date
- Mar 2026
- Lead sponsor
- IRCCS San Raffaele Roma
- Diseases
- Alzheimer disease
- NCT number
- NCT07883148
What you commit to
- Study type: Interventional
- Participants enrolled: 52
- From May 2024 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals with comorbidities which may interfere with cognitive status (e.g., previous stroke, normal pressure, hydrocephalus, alcohol abuse, brain tumor or brain metastasis);
- Previous medical history positive for psychiatric diseases (except for a recent onset of depression or other behavioral disturbances);
Other illness
- Blood clotting disorders, epilepsy, and corticosteroid treatment in the last 6 weeks;
Other
- Treatments which may interfere with cognitive status;
- Any contraindication to TPS;
- Non-compliance with the protocol requirements.
Who the study is looking for
- Individuals aged ≥18 years; if women, in menopause since at least 2 years;
- fulfilling the diagnostic criteria for MCI due to AD;
- Mini-Mental State Examination (MMSE) score ≥24;
- Clinical Dementia Rating (CDR) ≤0.5;
- Stable presence of an informant family member;
- Release of written informed consent prior to the study participation;
- Capacity of full compliance with the protocol requirements.
- Individuals aged ≥18 years; if women, in menopause since at least 2 years;
- Fulfilling the diagnostic criteria for AD;
- Mini-Mental State Examination (MMSE) score ≥18;
- Clinical Dementia Rating (CDR) =1;
- At least 3 months of stable antidementia therapy (if any);
- Stable presence of an informant family member;
- Release of written informed consent prior to the study participation;
- Capacity of full compliance with the protocol requirements.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.