Transcranial Pulse Stimulation for early dementia treatment
Transcranial Pulse Stimulation: a Potential New Treatment for Chronic Disorders of Consciousness/Cognition Due to Vegetative/Minimally Conscious States and Early Dementia
This study is testing if a new brain stimulation treatment can help improve thinking skills in people with early-stage Alzheimer's Disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ASL 1 Avezzano Sulmona L'Aquila Academic / other |
| Locations | 2 sites (L’Aquila, Italy and 1 other locations) |
| Trial ID | NCT06730438 on ClinicalTrials.gov |
What this trial studies
This research investigates the use of Transcranial Pulse Stimulation (TPS) as a potential treatment for patients with early-stage Alzheimer's Disease. The study aims to assess cognitive improvements through a double-blind, sham-controlled design, where participants will receive either real TPS or a placebo treatment over a four-week period. Patients will be monitored for cognitive changes and neurophysiological responses, including measurements of brain-derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF). The study seeks to enhance care for Alzheimer's patients by exploring innovative neuromodulation techniques.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with early-stage dementia lasting at least 12 months.
Not a fit: Patients with medical instability, contraindications to MRI, or other comorbidities affecting cognitive status may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new non-invasive option to improve cognitive function in patients with early dementia.
How similar studies have performed: While the approach of using TPS is innovative, similar neuromodulation techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
L’Aquila, Italy and 1 other locations
- San Salvatore Hospital — L’Aquila, Italy, Italy (Recruiting)
- San Salvatore Hospital — L’Aquila, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Francesca Pistoia, MD, PhD
- Email: francesca.pistoia@univaq.it
- Phone: +39862368657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.