- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03614962
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: SSM Ng, PhD
- Phone Number: +852 2766-4889
- Email: shamay.ng@polyu.edu.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- The Hong Kong Polytechnic University
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Contact:
- Shamay Ng, Dr
- Phone Number: 27664883
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Warmth + TENS group
All participants will be offered a hat device that elicits warmth and 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. |
Active Comparator: Warmth + placebo-TENS group
All participants will be offered a hat device that elicits warmth and 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.
|
Active Comparator: Warmth group
All participants will be offered a hat device that elicits 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.
|
Active Comparator: TENS group
All participants will be offered a hat device that elicits TENS only.
|
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.
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.
|
Sham Comparator: control group
All participants will be offered a hat device that without warmth or TENS output.
|
No warmth pad and TENS electrodes presented in the cap.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline
Time Frame: Baseline (0 week)
|
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.
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Baseline (0 week)
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The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - post intervention
Time Frame: 6 weeks
|
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.
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6 weeks
|
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - short term followup
Time Frame: 10 weeks
|
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.
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10 weeks
|
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - long term followup
Time Frame: 62 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chinese version of Disability Assessment for Dementia (C-DAD) - baseline
Time Frame: baseline (0 week)
|
C-DAD will be used to assess the participant's ability to perform a spectrum of functional activities, such as going on an outing and housekeeping.
During the assessment, a caregiver is asked to indicate if the participant was able to perform 47 daily activities within the previous weeks with the responses of 'yes', ''no' or 'not applicable'.
The result will then be converted into a scale ranging from 0 to 100, with a higher score indicates a higher level of functioning.
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baseline (0 week)
|
Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention
Time Frame: 6 weeks
|
C-DAD will be used to assess the participant's ability to perform a spectrum of functional activities, such as going on an outing and housekeeping.
During the assessment, a caregiver is asked to indicate if the participant was able to perform 47 daily activities within the previous weeks with the responses of 'yes', ''no' or 'not applicable'.
The result will then be converted into a scale ranging from 0 to 100, with a higher score indicates a higher level of functioning.
|
6 weeks
|
Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup
Time Frame: 10 weeks
|
C-DAD will be used to assess the participant's ability to perform a spectrum of functional activities, such as going on an outing and housekeeping.
During the assessment, a caregiver is asked to indicate if the participant was able to perform 47 daily activities within the previous weeks with the responses of 'yes', ''no' or 'not applicable'.
The result will then be converted into a scale ranging from 0 to 100, with a higher score indicates a higher level of functioning.
|
10 weeks
|
Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup
Time Frame: 62 weeks
|
C-DAD will be used to assess the participant's ability to perform a spectrum of functional activities, such as going on an outing and housekeeping.
During the assessment, a caregiver is asked to indicate if the participant was able to perform 47 daily activities within the previous weeks with the responses of 'yes', ''no' or 'not applicable'.
The result will then be converted into a scale ranging from 0 to 100, with a higher score indicates a higher level of functioning.
|
62 weeks
|
Pittsburg Sleep Quality Index (PSQI) - baseline
Time Frame: baseline (0 weeks)
|
PSQI will be used to assess the participant's sleep quality for the past months.
PSQI consists of 19 individual items including sleep duration, sleep latency, sleep disturbance etc.
The total score will be range from 0-21 and lower scores indicate a better sleep quality.
|
baseline (0 weeks)
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Pittsburg Sleep Quality Index (PSQI) - post intervention
Time Frame: 6 weeks
|
PSQI will be used to assess the participant's sleep quality for the past months.
PSQI consists of 19 individual items including sleep duration, sleep latency, sleep disturbance etc.
The total score will be range from 0-21 and lower scores indicate a better sleep quality.
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6 weeks
|
Pittsburg Sleep Quality Index (PSQI) - short term followup
Time Frame: 10 weeks
|
PSQI will be used to assess the participant's sleep quality for the past months.
PSQI consists of 19 individual items including sleep duration, sleep latency, sleep disturbance etc.
The total score will be range from 0-21 and lower scores indicate a better sleep quality.
|
10 weeks
|
Pittsburg Sleep Quality Index (PSQI) - long term followup
Time Frame: 62 weeks
|
PSQI will be used to assess the participant's sleep quality for the past months.
PSQI consists of 19 individual items including sleep duration, sleep latency, sleep disturbance etc.
The total score will be range from 0-21 and lower scores indicate a better sleep quality.
|
62 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: SSM Ng, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018_ITF_MRP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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