Study Results
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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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2025-07-21
2026-06-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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).
transcranial pulse stimulation (TPS)
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
90 Years
ALL
No
Sponsors
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Asia Pacific Institute of Healthy ageing
UNKNOWN
Associated medical supplies company limited
UNKNOWN
Dongguan University of Technology
UNKNOWN
SuZhou Engin Bio-medical Electronics.Co.Ltd.
UNKNOWN
Chinese University of Hong Kong
OTHER
Responsible Party
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Timothy Kwok
Professor
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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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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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