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| Name | Class |
|---|---|
| Asia Pacific Institute of Healthy ageing | UNKNOWN |
| Associated medical supplies company limited | UNKNOWN |
| Dongguan University of Technology | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Received transcranial pulse stimulation (TPS) treatment | Experimental | 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). |
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| Received transcranial pulse stimulation (TPS) sham treatment | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial pulse stimulation (TPS) | Device | The TPS/Sham-TPS therapy is administered for the first two weeks, followed by additional sessions at some week intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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） |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Neuropsychiatric Inventory total score. | The lower the score, the milder the neuropsychiatric symptoms; the higher the score, the more severe and frequent the symptoms, and the greater the burden on caregivers. Score range： 0-144 | baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week） |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KI SUM CHU, PhD candidate | Contact | (+852) 62087351 | sumkichu2015@link.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Timothy Chi Yui Kwok, PhD | Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese UNiversity of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese UNiversity of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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| Label | URL |
|---|---|
| This is official website of the Neurolith Transcranial Pulse Stimulation device | View source |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| SuZhou Engin Bio-medical Electronics.Co.Ltd. |
| UNKNOWN |
Participants with early AD, confirmed via blood tests, are randomly assigned to either a TPS treatment group or a placebo group. The treatment protocol involves an intensive TPS treatment period over two weeks followed by a continuous treatment period with additional treatments over some weeks. The placebo group receives sham treatment.
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| transcranial pulse stimulation (TPS-Sham) | Device | 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. |
|
| Change in the Animal Fluency Test score |
The more animal names you say within the specified time (the higher the score), the better your language fluency, cognitive processing speed, and semantic memory ability. Normal cognition typically has ≥ 15-18 (well-educated young or middle-aged individuals typically have ≥ 20). Mild cognitive impairment (MCI) may have 11-16 Dementia (such as Alzheimer's disease) typically has ≤ 12-14 , but may be lower. |
| baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week） |
| Change in the Disability Assessment for Dementia total score. | The higher the score, the greater the patient's functional independence and the better the ability to carry out daily life. The lower the score, the more severe the functional impairment and the greater the dependence on others for care. Score range：0-100% | 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） |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |