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NCT Number: NCT07143734

Transcranial Pulse Stimulation for Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer Dementia (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Hong Kong

Location status: Recruiting

Location contact

Cherrie Yip

CONTACT

[email protected]

（+852）3505 3846

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcranial pulse stimulation (TPS)

Device

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

transcranial pulse stimulation (TPS-Sham)

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.

Primary outcomes

  1. Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale score.

    Time frame: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）

    The lower the score, the better the cognitive function; the higher the score, the more severe the cognitive impairment.

    Score range: 0-85

Secondary outcomes

  1. Change in the Neuropsychiatric Inventory total score.

    Time frame: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）

    The lower the score, the milder the neuropsychiatric symptoms; the higher the score, the more severe and frequent the symptoms, and the greater the burden on caregivers.

    Score range： 0-144

  2. Change in the Animal Fluency Test score

    Time frame: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）

    The more animal names you say within the specified time (the higher the score), the better your language fluency, cognitive processing speed, and semantic memory ability.

    Normal cognition typically has ≥ 15-18 (well-educated young or middle-aged individuals typically have ≥ 20).

    Mild cognitive impairment (MCI) may have 11-16 Dementia (such as Alzheimer's disease) typically has ≤ 12-14 , but may be lower.

  3. Change in the Disability Assessment for Dementia total score.

    Time frame: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）

    The higher the score, the greater the patient's functional independence and the better the ability to carry out daily life. The lower the score, the more severe the functional impairment and the greater the dependence on others for care.

    Score range：0-100%

  4. Change in oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the cerebral blood

    Time frame: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）

  5. Change in plasma Aβ42/40

    Time frame: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）

Study contacts

Contact information is provided by the study sponsor or research team.

KI SUM CHU, PhD candidate

CONTACT

[email protected]

(+852) 62087351

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Asia Pacific Institute of Healthy ageing
  • Associated medical supplies company limited
  • Dongguan University of Technology
  • SuZhou Engin Bio-medical Electronics.Co.Ltd.

Registry information

Official study title

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

Acronym: TPS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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