Using warmth and TENS to improve cognitive functions in dementia patients

Efficacy of Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions and Behavioral Symptoms in Older Adults with Dementia: a Randomized, Controlled Clinical Trial

This study is testing if using warmth along with a special electrical treatment can help improve thinking and behavior in people with dementia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: The Hong Kong Polytechnic University (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT03614962 on ClinicalTrials.gov

What this trial studies

This study investigates the combined effects of warmth and transcutaneous electrical nerve stimulation (TENS) on cognitive functions in individuals diagnosed with dementia. Participants will be assigned to different groups receiving various interventions, including warmth with TENS, warmth with placebo-TENS, TENS alone, warmth alone, or a control group with no treatment. The goal is to determine if the combination of these treatments can lead to greater improvements in cognitive abilities and behavioral symptoms compared to other methods. The study builds on previous findings that suggest both TENS and passive body heating may enhance cognitive performance in dementia patients.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with Alzheimer's disease, vascular dementia, or mixed-type mild to major neurocognitive disorders who are in the mild to moderate stages of dementia.

Not a fit: Patients with unstable medical conditions or severe behavioral disturbances may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive treatment option to improve cognitive functions and quality of life for patients with dementia.

How similar studies have performed: Previous studies have shown promising results for TENS and passive body heating in improving cognitive functions, suggesting that this approach may be effective.

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

Where this trial is running

Hong Kong

• The Hong Kong Polytechnic University — Hong Kong, Hong Kong (Recruiting)

Study contacts

• Principal investigator: SSM Ng, PhD — The Hong Kong Polytechnic University
• Study coordinator: SSM Ng, PhD

Conditions Dementia; Transcutaneous electrical nerve stimulation; Cognitive; Memory