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

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).

Conditions

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

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.

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong

  collaborator OTHER

• The Hong Kong Polytechnic University

  lead OTHER

Principal Investigators

• SSM Ng, PhD · The Hong Kong Polytechnic University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2024-12-02

Completion

2024-12-02

Countries

• Hong Kong

Study Locations