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

Overview

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.

Interventions

• Device Warmth + TENS
  A hat device will offer the electrical stimulation (pulse width of 120 milliseconds at about 100 Hz with constant current 0.02mA-0.7 mA, intensity setting at sensory threshold) over 4 acupuncture points over the scalp, including Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20) and Shenting (GV24). Selection of acupuncture points has been based on the recommendation of traditional Chinese medicine. A custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortab
• Device Warmth + placebo-TENS
  A custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius. The TENS electrodes are presented in the cap but no output will be delivered via these electrodes.
• Device TENS
  A hat device will offer the electrical stimulation (pulse width of 120 milliseconds at about 100 Hz with constant current 0.02mA-0.7 mA, intensity setting at sensory threshold) over 4 acupuncture points over the scalp, including Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20) and Shenting (GV24). Selection of acupuncture points has been based on the recommendation of traditional Chinese medicine.
• Device Warmth only
  A custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius. No built-in TENS electrodes in the cap.
• Device control
  No warmth pad and TENS electrodes presented in the cap.

Primary outcome measures

• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline [Time frame: Baseline (0 week)]
• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - post intervention [Time frame: 6 weeks]
• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - short term followup [Time frame: 10 weeks]
• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - long term followup [Time frame: 62 weeks]

Secondary outcome measures (8)

• Chinese version of Disability Assessment for Dementia (C-DAD) - baseline [Time frame: baseline (0 week)]
• Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention [Time frame: 6 weeks]
• Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup [Time frame: 10 weeks]
• Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup [Time frame: 62 weeks]
• Pittsburg Sleep Quality Index (PSQI) - baseline [Time frame: baseline (0 weeks)]
• Pittsburg Sleep Quality Index (PSQI) - post intervention [Time frame: 6 weeks]
• Pittsburg Sleep Quality Index (PSQI) - short term followup [Time frame: 10 weeks]
• Pittsburg Sleep Quality Index (PSQI) - long term followup [Time frame: 62 weeks]

Eligibility criteria

Inclusion criteria

• 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;
• are categorized in the mild or moderate degree of dementia based on the Global Deterioration Scale;
• have a stable drug intake for the past 3 months;
• live with at least 1 caregiver in the community;
• are able to follow simple instructions;
• are able to give informed consent by them or their family members.

Exclusion criteria

• have unstable medical conditions or severe behavioural disturbances, which do not allow participation in the study as judged by the study psychogeriatrician,
• 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.
• use a cardiac pacemaker,
• live in old age home, elderly home or care and attention homes,
• receive long term nursing home placements of patients during the treatment phase

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT03614962 · 2018_ITF_MRP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗