Clinical trial NCT03614962: Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions in People with Dementia
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Keywords: Transcutaneous electrical nerve stimulation
Cognitive
Memory
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Shatin, Hong Kong
First posted: 2018-08-03
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Acupuncture, a primary therapeutic method in traditional Chinese medicine, has been used for patients with dementia to improve memory, orientation, calculation, and self-managing ability in patients having dementia and prevent decline of cognitive functions. Results of animal studies have demonstrated that electroacupuncture on the head region is effective in managing the symptoms associated with dementia, including vascular dementia.

A review of 8 studies on effects of TENS on non-pain related cognitive and behavioural functioning in patients with Alzheimer's disease and non-demented patients concluded that TENS could improve memory, affective behaviour and rest-activity rhythm in patients having Alzheimer's disease.

Passive body heating is another novel physical intervention strategy which potentially can relieve the symptoms of dementia. A previous study demonstrated that the attention function of 15 elderly, measured by the reaction time in the Rapid Visual Processing Test, improved after passive body heating via a thermal suit. Moreover, 30 minutes of hot-water immersion improved the sleep quality in 13 people with vascular dementia.

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

Primary outcomes:
measure: The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline
timeFrame: Baseline (0 week)
measure: The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - post intervention
timeFrame: 6 weeks
measure: The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - short term followup
timeFrame: 10 weeks
measure: The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - long term followup
timeFrame: 62 weeks
Secondary outcomes:
measure: Chinese version of Disability Assessment for Dementia (C-DAD) - baseline
timeFrame: baseline (0 week)
measure: Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention
timeFrame: 6 weeks
measure: Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup
timeFrame: 10 weeks
measure: Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup
timeFrame: 62 weeks
measure: Pittsburg Sleep Quality Index (PSQI) - baseline
timeFrame: baseline (0 weeks)
measure: Pittsburg Sleep Quality Index (PSQI) - post intervention
timeFrame: 6 weeks
measure: Pittsburg Sleep Quality Index (PSQI) - short term followup
timeFrame: 10 weeks
measure: Pittsburg Sleep Quality Index (PSQI) - long term followup
timeFrame: 62 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: SSM Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: