RecruitingPhase 2NCT07143734

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


Sponsor

Chinese University of Hong Kong

Enrollment

40 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 90 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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

Interventions

DEVICEtranscranial pulse stimulation (TPS)

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

DEVICEtranscranial 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.


Locations(1)

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

Hong Kong, Hong Kong

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NCT07143734


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