Home-based Transcranial Direct Current Stimulation (tDCS) for Apathy in Alzheimer's Disease and Related Dementias (ADRD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of Participants Included and Who Successfully Completed the Protocol
研究概览
简要总结
The purpose of this study is to assess feasibility, acceptability, and safety of providing tDCS to Alzheimer's disease and related dementias (ADRD) patients with apathy and to assess the efficacy of tDCS for ADRD-related symptoms, with a primary focus on apathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of possible or probable ADRD according to the National Institute of Aging - Alzheimer's Association diagnostic criteria
- •Mild or moderate dementia, as defined by a MMSE score between 14 and 26
- •Clinically meaningful apathy for at least four weeks, clinically diagnosed according to 2018 Apathy Diagnostic Criteria or defined as Neuropsychiatric Inventory (NPI-Q) apathy score equal or above 4 (i.e., severity of 'moderate' or greater and caregiver distress 'mild' or greater).
- •Stable doses of cholinesterase inhibitors, memantine and other psychotropic medications for at least three months.
排除标准
- •Unstable medical conditions
- •History of epilepsy
- •Metallic objects in the brain
- •Diagnosis of major depression and/or a score higher than 18 on the Cornell Scale for Depression in Dementia
结局指标
主要结局
Number of Participants Included and Who Successfully Completed the Protocol
时间窗: through study completion (about 12 weeks)
The feasibility will be assessed based on the recruitment rate (per month), randomization success, blind success, retention, and attrition rates.
How Satisfied the Participant Was With the Treatment as Measured by the tDCS Experience Questionnaire
时间窗: 6 weeks post-treatment (12 weeks from baseline)
Acceptability will be measured using a Likert scale composed by 10 questions, each one ranging from 0 (strongly disagree) to 10 (strongly agree). The 10 prompts are as followed: 1. It was easy to prepare the device and accessories 2. The device was unnecessarily complex 3. The device was easy to use 4. I felt the video conferences with a technical person were helpful 5. I would imagine that most people would learn to use this device quickly 6. The device was cumbersome to use 7. I felt confident using the device 8. I needed to learn a lot of things before I could get going with this device 9. The effectiveness of the treatment increased over the course of treatment 10. Overall, I felt that transcranial electrical stimulation treatment benefited me
Safety of Home-based tDCS Treatment as Assessed by Side Effects
时间窗: From baseline to week 12
Safety will be assessed with a questionnaire about side effects that include itching, burning, headache, fatigue, and dizziness.
次要结局
- Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Caregiver Distress Score)(Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline))
- Cognition as Evaluated by the Mini-Mental State Examination (MMSE)(Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment(12 weeks from baseline))
- Apathy as Assessed by the Brief Dimensional Apathy Scale (b-DAS)(Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline))
- Dementia-related Behavioral Symptoms as Assessed by the Neuropsychiatric Inventory (NPI-Q) Scale (Severity Score)(Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline))
- Depressive Symptoms as Assessed by the Cornell Scale for Depression in Dementia(Baseline, treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline))
- Apathy as Measured by the Apathy Evaluation Scale (AES)(Baseline, treatment week 2 (2 weeks from baseline), treatment week 4 (4 weeks from baseline), treatment week 6 (6 weeks from baseline), and 6 weeks post-treatment (12 weeks from baseline))
研究者
Antonio L. Teixeira
Professor
The University of Texas Health Science Center, Houston