NCT03614962 Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions in People with Dementia
| NCT ID | NCT03614962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2019-03-01 |
| Primary Completion | 2024-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2019-03-01 with a primary completion date of 2024-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evidence showed that both TENS and passive body heating are potential treatment strategies for improving cognitive functions in people with dementia. It is hypothesized that hat device (Warmth +TENS) over the 4 acupuncture points would induce a greater improvement in cognitive functions and behavioural symptoms when compared with other hat devices (Warmth + placebo-TENS; TENS only; Warmth alone) and Control (hat device with no warmth and no TENS).
Eligibility Criteria
Inclusion Criteria: 1. are currently diagnosed having Alzheimer's disease, vascular dementia or mixed-type mild to major neurocognitive disorder based on the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM -5) by psychogeriatrician with more than 3 years of experience in dementia diagnosis; 2. are categorized in the mild or moderate degree of dementia based on the Global Deterioration Scale; 3. have a stable drug intake for the past 3 months; 4. live with at least 1 caregiver in the community; 5. are able to follow simple instructions; 6. are able to give informed consent by them or their family members. Exclusion Criteria: 1. have unstable medical conditions or severe behavioural disturbances, which do not allow participation in the study as judged by the study psychogeriatrician, 2. have any additional medical, cardiovascular , orthopedic or cognitive conditions, such as having uncontrolled hypertension unstable angina and comorbid schizophrenia, that would hinder proper assessment and treatment. 3. use a cardiac pacemaker, 4. live in old age home, elderly home or care and attention homes, 5. receive long term nursing home placements of patients during the treatment phase
Contact & Investigator
SSM Ng, PhD
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT03614962 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03614962 currently recruiting?
Yes, NCT03614962 is actively recruiting participants. Contact the research team at shamay.ng@polyu.edu.hk for enrollment information.
Where is the NCT03614962 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT03614962 clinical trial?
NCT03614962 is sponsored by The Hong Kong Polytechnic University. The principal investigator is SSM Ng, PhD at The Hong Kong Polytechnic University. The trial plans to enroll 150 participants.