Transcranial Pulse Stimulation for Alzheimer's Disease

NCT ID: NCT07143734

Last Updated: 2025-09-16

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-21

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Alzheimer Dementia (AD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants with early AD, confirmed via blood tests, are randomly assigned to either a TPS treatment group or a placebo group. The treatment protocol involves an intensive TPS treatment period over two weeks followed by a continuous treatment period with additional treatments over some weeks. The placebo group receives sham treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Received transcranial pulse stimulation (TPS) treatment

Receiving transcranial pulse stimulation (TPS) as part of an investigation into its effectiveness for improving cognitive function, memory, functional status, and neuropsychiatric symptoms in subjects with Alzheimer's Disease (AD).

Group Type EXPERIMENTAL

transcranial pulse stimulation (TPS)

Intervention Type DEVICE

The TPS/Sham-TPS therapy is administered for the first two weeks, followed by additional sessions at some week intervals.

Received transcranial pulse stimulation (TPS) sham treatment

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.

Group Type SHAM_COMPARATOR

transcranial pulse stimulation (TPS-Sham)

Intervention Type DEVICE

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.

Interventions

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transcranial pulse stimulation (TPS)

The TPS/Sham-TPS therapy is administered for the first two weeks, followed by additional sessions at some week intervals.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults who have been clinically diagnosed with Alzheimer's Disease in the early stage 2-6a according to the Functional Assessment Staging Test (In Appendix A)
* The mental capacity to give informed consent for research is made by an experienced geriatrician based on Appendix A.
* Aged 60-90 years old.
* Able to make informed consent under assistance, which is witnessed and signed by a family caregiver.

Exclusion Criteria

* Cannot understand Chinese.
* Mentally incapacitated, unable to provide informed consent
* Inability to remain still for 30 minutes
* Lack of available family caregiver to answer questionnaires
* Alcohol or substance dependence
* Major neurological conditions, including:
* Brain tumor
* Brain aneurysm
* Presence of any metal implants in the brain
* Hemophilia or other blood clotting disorders
* History of thrombosis
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asia Pacific Institute of Healthy ageing

UNKNOWN

Sponsor Role collaborator

Associated medical supplies company limited

UNKNOWN

Sponsor Role collaborator

Dongguan University of Technology

UNKNOWN

Sponsor Role collaborator

SuZhou Engin Bio-medical Electronics.Co.Ltd.

UNKNOWN

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Timothy Kwok

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy Chi Yui Kwok, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese UNiversity of Hong Kong

Locations

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Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese UNiversity of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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KI SUM CHU, PhD candidate

Role: CONTACT

(+852) 62087351

Facility Contacts

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Cherrie Yip

Role: primary

(+852)3505 3846

Related Links

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https://www.storzmedical.com/en/disciplines/tps-products-for-the-treatment-of-alzheimer-s-disease/neurolith/

This is official website of the Neurolith Transcranial Pulse Stimulation device

Other Identifiers

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2024.645

Identifier Type: -

Identifier Source: org_study_id

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