Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions in People with Dementia
- Conditions
- Dementia
- Interventions
- Device: controlDevice: Warmth + placebo-TENSDevice: Warmth + TENSDevice: Warmth onlyDevice: TENS
- Registration Number
- NCT03614962
- Lead Sponsor
- The Hong Kong Polytechnic University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group control All participants will be offered a hat device that without warmth or TENS output. Warmth + placebo-TENS group Warmth + placebo-TENS All participants will be offered a hat device that elicits warmth and placebo-TENS. Warmth + TENS group Warmth + TENS All participants will be offered a hat device that elicits warmth and TENS. TENS group TENS All participants will be offered a hat device that elicits TENS only. Warmth group Warmth only All participants will be offered a hat device that elicits warmth only. TENS group Warmth + TENS All participants will be offered a hat device that elicits TENS only.
- Primary Outcome Measures
Name Time Method The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline 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.
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - post intervention 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.
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - short term followup 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.
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - long term followup 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.
- Secondary Outcome Measures
Name Time Method Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup 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.
Chinese version of Disability Assessment for Dementia (C-DAD) - baseline 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.
Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention 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.
Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup 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.
Pittsburg Sleep Quality Index (PSQI) - post intervention 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.
Pittsburg Sleep Quality Index (PSQI) - baseline 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.
Pittsburg Sleep Quality Index (PSQI) - short term followup 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.
Pittsburg Sleep Quality Index (PSQI) - long term followup 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.
Trial Locations
- Locations (1)
The Hong Kong Polytechnic University
đź‡đź‡°Hong Kong, Hong Kong