NCT07143734

Transcranial Pulse Stimulation for Alzheimer's Disease

A Pilot Randomized Placebo-Controlled Trial of Transcranial Pulse Stimulation (TPS) in Early Alzheimer's Disease (AD) Subjects

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

TPS is a non-invasive therapeutic modality that uses focused, low-energy pulse stimulation to stimulate tissue regeneration and reduce inflammation. In the context of neurological disorders, it is hypothesized that TPS can modulate neuronal activity, enhance synaptic plasticity, and reduce neuroinflammation. It is a relatively new application in neurological disease treatment and is still under intense investigation.

Detailed description

This pilot randomized placebo-controlled trial investigates the effects of transcranial pulse stimulation in subjects with early Alzheimer's Disease (AD). The TPS/Sham-TPS is administered for the first two weeks, followed by additional sessions at some week intervals. The transcranial pulse stimulation device used in this trial is a CE-certified medical instrument (ISO 9001 and ISO 13485). The study aims to evaluate cognitive function, and neuropsychiatric symptoms using the some cognitive assessment tools, Frontal near-infrared spectroscopy (fNIRS), and fasting blood test at baseline at week 12. This study is expected to lay the groundwork for future, larger-scale studies

Conditions

• Alzheimer Dementia (AD)

Interventions

Type	Name	Description
DEVICE	transcranial pulse stimulation (TPS)	The TPS/Sham-TPS therapy is administered for the first two weeks, followed by additional sessions at some week intervals.
DEVICE	transcranial pulse stimulation (TPS-Sham)	Participants will undergo an identical procedure using a device that mimics the sound and sensation of active TPS but delivers no therapeutic energy pulses to the brain.

Timeline

• Start date: 2025-07-21
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2025-08-27
• Last updated: 2025-09-16

Locations

1 site across 1 country: Hong Kong