RecruitingNot ApplicableNCT03614962

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

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


Sponsor

The Hong Kong Polytechnic University

Enrollment

150 participants

Start Date

Mar 1, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called TENS, a medical device called Warmth + TENS, and others for people with dementia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWarmth + 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 comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius.

DEVICEWarmth + 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.

DEVICETENS

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.

DEVICEWarmth 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.

DEVICEcontrol

No warmth pad and TENS electrodes presented in the cap.


Locations(1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

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NCT03614962


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