Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions in People with Dementia

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Dementia

Treatments: Device: control; Device: TENS; Device: Warmth + placebo-TENS; Device: Warmth + TENS; Device: Warmth only

Study type: Interventional

Funder types: Other

Identifiers

NCT03614962

2018_ITF_MRP

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 5 patient groups

Warmth + TENS group

Experimental group

Description:

All participants will be offered a hat device that elicits warmth and TENS.

Treatment:

Device: Warmth + TENS

Warmth + placebo-TENS group

Active Comparator group

Description:

All participants will be offered a hat device that elicits warmth and placebo-TENS.

Treatment:

Device: Warmth + placebo-TENS

Warmth group

Active Comparator group

Description:

All participants will be offered a hat device that elicits warmth only.

Treatment:

Device: Warmth only

TENS group

Active Comparator group

Description:

All participants will be offered a hat device that elicits TENS only.

Treatment:

Device: Warmth + TENS

Device: TENS

control group

Sham Comparator group

Description:

All participants will be offered a hat device that without warmth or TENS output.

Treatment:

Device: control