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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство 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 comfortab
• Устройство 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.
• Устройство 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.
• Устройство 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.
• Устройство control
  No warmth pad and TENS electrodes presented in the cap.

Первичные конечные точки

• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline [Срок оценки: Baseline (0 week)]
• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - post intervention [Срок оценки: 6 weeks]
• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - short term followup [Срок оценки: 10 weeks]
• The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - long term followup [Срок оценки: 62 weeks]

Вторичные конечные точки (8)

• Chinese version of Disability Assessment for Dementia (C-DAD) - baseline [Срок оценки: baseline (0 week)]
• Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention [Срок оценки: 6 weeks]
• Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup [Срок оценки: 10 weeks]
• Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup [Срок оценки: 62 weeks]
• Pittsburg Sleep Quality Index (PSQI) - baseline [Срок оценки: baseline (0 weeks)]
• Pittsburg Sleep Quality Index (PSQI) - post intervention [Срок оценки: 6 weeks]
• Pittsburg Sleep Quality Index (PSQI) - short term followup [Срок оценки: 10 weeks]
• Pittsburg Sleep Quality Index (PSQI) - long term followup [Срок оценки: 62 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT03614962 · 2018_ITF_MRP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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