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

NCT03614962 | Recruiting DMC

• 1 other identifier: 2018_ITF_MRP
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Dementia

Keywords

Transcutaneous electrical nerve stimulation; Cognitive; Memory

Outcome Measures

Primary Outcomes (4)

• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline

  The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.

  Baseline (0 week)

• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - post intervention

  The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.

  6 weeks

• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - short term followup

  The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.

  10 weeks

• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - long term followup

  The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.

  62 weeks

Secondary Outcomes (8)

• Chinese version of Disability Assessment for Dementia (C-DAD) - baseline

  baseline (0 week)

• Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention

  6 weeks

• Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup

  10 weeks

• Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup

  62 weeks

• Pittsburg Sleep Quality Index (PSQI) - baseline

  baseline (0 weeks)

Study Arms (5)

Warmth + TENS group

EXPERIMENTAL

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

Device: Warmth + TENS

Warmth + placebo-TENS group

ACTIVE COMPARATOR

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

Device: Warmth + placebo-TENS

Warmth group

ACTIVE COMPARATOR

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

Device: Warmth only

TENS group

ACTIVE COMPARATOR

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

Device: Warmth + TENS; Device: TENS

control group

SHAM COMPARATOR

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

Device: control

Interventions

Warmth + TENS DEVICE

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.

TENS group; Warmth + TENS group

Warmth + placebo-TENS DEVICE

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.

Warmth + placebo-TENS group

TENS DEVICE

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.

TENS group

Warmth only DEVICE

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.

Warmth group

control DEVICE

No warmth pad and TENS electrodes presented in the cap.

control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Dementia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• SSM Ng, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SSM Ng, PhD

CONTACT

+852 2766-4889; shamay.ng@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: August 3, 2018
• Study Start: March 1, 2019
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

HK (1)