Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-06 @ 5:39 AM
Study NCT ID:
NCT07143734
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Pulse Stimulation for Alzheimer's Disease
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
A Pilot Randomized Placebo-Controlled Trial of Transcranial Pulse Stimulation (TPS) in Early Alzheimer's Disease (AD) Subjects
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TPS
Brief 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: