Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of electroacupuncture in the treatment of agitation symptoms in patients with Alzheimer's disease (AD). Meanwhile the study aims to explore the brain central mechanism of electroacupuncture in the treatment of agitation symptoms in patients with AD by using resting state functional magnetic resonance technology.
This is a multicenter, parallel-group, patient-blinded and outcome-assessor-blinded randomized controlled trial consisting of two stages: a 8-week treatment period followed by a 8-week follow-up period. The study aims to assess therapeutic efficacy and safety of electroacupuncture for agitated symptoms of AD. Approximately 224 AD patients with symptoms of agitation will be randomly assigned to the electroacupuncture group or micro-electroacupuncture group. 50 patients in each of the two groups will be selected to complete rs-fMRI scans before the initial treatment and after the last treatment in order to investigate the central mechanism underlying the effects of electroacupuncture treatment on functional activity in patients with AD patients with symptoms of agitation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture group | Experimental | Needles will be inserted at 11 acupoints. Acupoints will be added electrical stimulation via a low-frequency neural regulator (electrical stimulator) respectively with a disperse-dense wave after insertion of all needles. Twenty-minute treatments will be delivered three times weekly for 8 weeks. |
|
| Micro-acupuncture group | Other | 11 needles will be inserted at acupoints with 1-3 mm in depth. The acupoints will then be connected to the electrical stimulator in accordance with the electroacupuncture group. The frequency of the electroacupuncture is the same as that of the electroacupuncture group, which is briefly energized at the beginning for 30s.Twenty-minute treatments will be delivered three times weekly for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture group | Other | Electroacupuncture treatment consists of conventional acupuncture and electrical stimulation. After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohen Mansfield Agitation Inventory (CMAI) | CMAI is one of the most widely used tools for assessing agitated behaviors that affect patients' quality of life and burden caregivers. The scale contains 29 items, including different agitated behaviors and emotional states, to which the assessed responds based on their own observations and experiences. The scores for all items are added together to give a total score. The higher the score, the more severe the agitated behavior. | CMAI will be evaluated after the final treatment at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohen Mansfield Agitation Inventory (CMAI) | CMAI is one of the most widely used tools for assessing agitated behaviors that affect patients' quality of life and burden caregivers. The scale contains 29 items, including different agitated behaviors and emotional states, to which the assessed responds based on their own observations and experiences. The scores for all items are added together to give a total score. The higher the score, the more severe the agitated behavior. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baohui Jia | Contact | 010-88001454 | jiabaohui2504@gamyy.cn | |
| Ran Li | Contact | 18801094908 | lcgxliran@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Baohui Jia | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing United Family Rehabilitation Hospital | Beijing | Beijing Municipality | 100015 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Micro-acupuncture group | Other | After acupuncture, the electrical stimulation is continuously stimulated for 20 minutes. Electrical stimulation is applied briefly for the first 30 seconds. |
|
| The CMAI will be evaluated at week 4 of treatment and at week 4 and week 8 of follow-up |
| Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change(mADCS-CGIC) | mADCS-CGIC is a global rating of change developed to assess clinically significant change in symptoms over time in AD clinical trials. Clinicians rate patient agitation on the mADCS-CGIC as: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7) compared to baseline symptoms. | The mADCS-CGIC assessment will be completed before treatment and at week 8 of treatment. |
| the Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) | The BEHAVE-AD scale is used to assess the behavioral pathology of patients with Alzheimer's disease. It contains 25 items to assess patients' symptoms and severity across multiple behavioral areas. The higher the total score of BEHAVE-AD, the more serious the behavioral pathology of the patient. | The BEHAVE-AD assessment will be completed before treatment and at week 8 of treatment. |
| Neuropsychiatric Inventory (NPI) | NPI is used to evaluate neuropsychiatric behavioral symptoms of dementia patients. The scale assesses the neuropsychiatric disorders of patients according to the caregiver's view of the patient's behavior and the corresponding distress felt by the patient. The scoring range of the patient evaluation scale is 0-144 points, and the scoring of the caregiver distress scale is 0-60 points, the lower the score is, the better the patient's condition is. | NPI will be completed before treatment and at week 8 of treatment. |
| Mini-mental State Examination (MMSE) | The MMSE scale can comprehensively, accurately and quickly reflect the intellectual state and cognitive function defect of the subjects. The total score ranges from 0 to 30 points, and the higher the score is, the better the cognitive function is | MMSE will be completed before treatment and at week 8 of treatment. |
| Alzheimer disease assessment scale cognition (ADAS-Cog) | The ADAS-Cog scale is a scale commonly used to assess cognitive impairment in Alzheimer's patients on a scale ranging from 0 to 70 points, with higher scores indicating more severe cognitive impairment. | ADAS-Cog scale will be completed before treatment and at week 8 of treatment. |
| Activities of daily living (ADL) | The ADL consists of the Physical self-maintenance scale (PSMS) and the Instrumental Activities of daily living Scale (IADL). Higher scores indicating lower ability. | ADL scale will be completed before treatment and at week 8 of treatment. |
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI Scale is a standardized tool used to assess sleep quality and contains 7 sections covering the main aspects of sleep quality. Each section was scored on a scale of 0-3, and the overall score was 0-21, with higher scores indicating poorer sleep quality. | PSQI will be completed before treatment and at week 8 of treatment. |
| Zarit Burden Interview(ZBI) | The ZBI scale is a tool used to assess the degree of psychological and physical burden on caregivers caring for family members with cognitive impairment or chronic illness. The total score ranges from 0 to 88, with higher scores indicating higher caregiving burden. | ZBI will be completed before treatment and at week 8 of treatment. |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | 100053 | China |
|
| Xuanwu Hospital of Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
|
| Beijing Geriatric Hospital | Beijing | Beijing Municipality | 100095 | China |
|
| Fujian University of Traditional Chinese Medicine | Fuzhou | Fujian | 350122 | China |
|
| The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine | Harbin | Heilongjiang | 150001 | China |
|
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided