Back to resultsWarmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions in People With Dementia
Primary Purpose
Dementia
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Warmth + TENS
Warmth + placebo-TENS
TENS
Warmth only
control
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Transcutaneous electrical nerve stimulation, Cognitive, Memory
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
Sites / Locations
- The Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Warmth + TENS group
Warmth + placebo-TENS group
Warmth group
TENS group
control group
Arm Description
All participants will be offered a hat device that elicits warmth and TENS.
All participants will be offered a hat device that elicits warmth and placebo-TENS.
All participants will be offered a hat device that elicits warmth only.
All participants will be offered a hat device that elicits TENS only.
All participants will be offered a hat device that without warmth or TENS output.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Chinese version of Disability Assessment for Dementia (C-DAD) - baseline
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.
Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention
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.
Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup
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.
Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup
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.
Pittsburg Sleep Quality Index (PSQI) - baseline
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.
Pittsburg Sleep Quality Index (PSQI) - post intervention
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.
Pittsburg Sleep Quality Index (PSQI) - short term followup
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.
Pittsburg Sleep Quality Index (PSQI) - long term followup
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.
Full Information
NCT ID
NCT03614962
First Posted
July 15, 2018
Last Updated
September 20, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
Prince of Wales Hospital, Shatin, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03614962
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 2, 2024 (Anticipated)
Study Completion Date
December 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Prince of Wales Hospital, Shatin, Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Transcutaneous electrical nerve stimulation, Cognitive, Memory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Warmth + TENS group
Arm Type
Experimental
Arm Description
All participants will be offered a hat device that elicits warmth and TENS.
Arm Title
Warmth + placebo-TENS group
Arm Type
Active Comparator
Arm Description
All participants will be offered a hat device that elicits warmth and placebo-TENS.
Arm Title
Warmth group
Arm Type
Active Comparator
Arm Description
All participants will be offered a hat device that elicits warmth only.
Arm Title
TENS group
Arm Type
Active Comparator
Arm Description
All participants will be offered a hat device that elicits TENS only.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
All participants will be offered a hat device that without warmth or TENS output.
Intervention Type
Device
Intervention Name(s)
Warmth + TENS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Warmth + placebo-TENS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Warmth only
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
control
Intervention Description
No warmth pad and TENS electrodes presented in the cap.
Primary Outcome Measure Information:
Title
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline
Description
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.
Time Frame
Baseline (0 week)
Title
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - post intervention
Description
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.
Time Frame
6 weeks
Title
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - short term followup
Description
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.
Time Frame
10 weeks
Title
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - long term followup
Description
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.
Time Frame
62 weeks
Secondary Outcome Measure Information:
Title
Chinese version of Disability Assessment for Dementia (C-DAD) - baseline
Description
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.
Time Frame
baseline (0 week)
Title
Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention
Description
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.
Time Frame
6 weeks
Title
Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup
Description
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.
Time Frame
10 weeks
Title
Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup
Description
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.
Time Frame
62 weeks
Title
Pittsburg Sleep Quality Index (PSQI) - baseline
Description
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.
Time Frame
baseline (0 weeks)
Title
Pittsburg Sleep Quality Index (PSQI) - post intervention
Description
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.
Time Frame
6 weeks
Title
Pittsburg Sleep Quality Index (PSQI) - short term followup
Description
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.
Time Frame
10 weeks
Title
Pittsburg Sleep Quality Index (PSQI) - long term followup
Description
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.
Time Frame
62 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SSM Ng, PhD
Phone
+852 2766-4889
Email
shamay.ng@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SSM Ng, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shamay Ng, Dr
Phone
27664883
12. IPD Sharing Statement
Learn more about this trial
Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions in People With Dementia
We'll reach out to this number within 24 hrs