Transcranial Pulse Stimulation for Alzheimer's Disease (TPS)

The Chinese University of Hong Kong

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer Dementia (AD)

Treatments: Device: transcranial pulse stimulation (TPS-Sham); Device: transcranial pulse stimulation (TPS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07143734

2024.645

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Received transcranial pulse stimulation (TPS) treatment

Experimental group

Description:

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).

Treatment:

Device: transcranial pulse stimulation (TPS)

Received transcranial pulse stimulation (TPS) sham treatment

Sham Comparator group

Description:

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.

Treatment:

Device: transcranial pulse stimulation (TPS-Sham)