Transcranial Pulse Stimulation for Alzheimer's Disease
TPS
A Pilot Randomized Placebo-Controlled Trial of Transcranial Pulse Stimulation (TPS) in Early Alzheimer's Disease (AD) Subjects
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2025
CompletedFirst Submitted
Initial submission to the registry
August 20, 2025
CompletedFirst Posted
Study publicly available on registry
August 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedSeptember 16, 2025
September 1, 2025
8 months
August 20, 2025
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale score.
The lower the score, the better the cognitive function; the higher the score, the more severe the cognitive impairment. Score range: 0-85
baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）
Secondary Outcomes (5)
Change in the Neuropsychiatric Inventory total score.
baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）
Change in the Animal Fluency Test score
baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）
Change in the Disability Assessment for Dementia total score.
baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）
Change in oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the cerebral blood
baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）
Change in plasma Aβ42/40
baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）
Study Arms (2)
Received transcranial pulse stimulation (TPS) treatment
EXPERIMENTALReceiving 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).
Received transcranial pulse stimulation (TPS) sham treatment
SHAM COMPARATORParticipants 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
The TPS/Sham-TPS therapy is administered for the first two weeks, followed by additional sessions at some week intervals.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese University of Hong Konglead
- Asia Pacific Institute of Healthy ageingcollaborator
- Associated medical supplies company limitedcollaborator
- Dongguan University of Technologycollaborator
- SuZhou Engin Bio-medical Electronics.Co.Ltd.collaborator
Study Sites (1)
Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese UNiversity of Hong Kong
Hong Kong, Hong Kong
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Chi Yui Kwok, PhD
Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese UNiversity of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 20, 2025
First Posted
August 27, 2025
Study Start
July 21, 2025
Primary Completion
April 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
September 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share