Transcranial Pulse Stimulation for Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial pulse stimulation (TPS), transcranial pulse stimulation (TPS-Sham).
- Who it may be relevant to
- Registry conditions: Alzheimer Dementia (AD). Basic parameters: 60 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Randomized Placebo-Controlled Trial of Transcranial Pulse Stimulation (TPS) in Early Alzheimer's Disease (AD) Subjects
Overview
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.
Detailed 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
Interventions
- Device transcranial pulse stimulation (TPS)
The TPS/Sham-TPS therapy is administered for the first two weeks, followed by additional sessions at some week intervals. - Device 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.
Primary outcome measures
- 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）]
Secondary outcome measures (5)
- Change in the Neuropsychiatric Inventory total score. [Time frame: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）]
- Change in the Animal Fluency Test score [Time frame: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）]
- Change in the Disability Assessment for Dementia total score. [Time frame: 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 [Time frame: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）]
- Change in plasma Aβ42/40 [Time frame: baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese UNiversity of Hong — Hong Kong
Identifiers
NCT: NCT07143734 · 2024.645