Transcranial Pulse Stimulation for Alzheimer's Disease
ConditionAlzheimer Dementia (AD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60-90
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial pulse stimulation (TPS)
DeviceThe TPS/Sham-TPS therapy is administered for the first two weeks, followed by additional sessions at some week intervals.
transcranial pulse stimulation (TPS-Sham)
DeviceParticipants 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 groups
40 Participants
are divided into 2 treatment groupsGroup A: Received transcranial pulse stimulation (TPS) treatmentExperimental treatment 1 intervention
Group B: Received transcranial pulse stimulation (TPS) sham treatmentSham comparator 1 intervention
Trial outcomes
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
Time frame
baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）Secondary outcomes
1
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
Time frame
baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）2
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.
Time frame
baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）3
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%
Time frame
baseline（ 1st Week）； follow-up （ after finishing the TPS therapy at 12th week）4
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）Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese University of Hong Kong
Lead sponsor
Asia Pacific Institute of Healthy ageing
Collaborator
Associated medical supplies company limited
Collaborator
Dongguan University of Technology
Collaborator
SuZhou Engin Bio-medical Electronics.Co.Ltd.
Collaborator
Source ClinicalTrials.gov