Home-based Transcranial Direct Current Stimulation Open Trial for Behavioral and Cognitive Symptoms in Huntington's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility as assessed by the 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 transcranial direct current stimulation( tDCS) to Huntingtons Disease (HD) patients in the early to middle stages and to assess the efficacy of tDCS for HD-related behavioral, cognitive and other symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant:
- •Inclusion Criteria:
- •confirmed HD mutation carriers and/or established family history alongside typical symptoms (i.e. chorea) of HD;
- •early (stages 1 and 2) or moderate (stage 3) stages according to Shoulson-Fahn
- •exhibit mild to moderate behavioral symptoms defined by severity scores in the PBA-S between 1 and 3 for any of the evaluated symptoms and no symptoms with a severity score of 4
- •stable doses of medications for at least one month
- •Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
排除标准
- •unstable medical conditions
- •history of epilepsy
- •metallic objects in the brain
- •Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
- •clinical diagnosis of major cognitive disorder or dementia
- •Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 or type 5 based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening
- •simultaneous participation in other clinical trial
- •Individuals determined to be incapable of consent per past medical history or via assessment by the study staff at time of consent.
- •Inclusion Criteria:
- •willingness to participate in the study
- •Exclusion Criteria:
- •motor/cognitive symptoms related to Alzheimer's disease or Huntington's disease that might impair the ability to assist the participant during the research study.
研究组 & 干预措施
active tDCS
干预措施: active tDCS (Device)
结局指标
主要结局
Feasibility as assessed by the number of participants included and who successfully completed the protocol
时间窗: through study completion, an average of 8 weeks
Change in safety of home-based tDCS treatment as as assessed by the tDCS side effect questionnaire
时间窗: week 2, week 4
Safety will be assessed with a 10-item questionnaire about side effects, including itching, burning, headache, fatigue, and dizziness. Each question is scored form 0-10, with a total score range of 0-10 and a higher score indicating more side effects.
Change in acceptability of the treatment as assessed by the tDCS acceptability questionnaire
时间窗: Baseline, week 2, week 4, week 8
Acceptability will be evaluated using a Likert scale (from 0 \[strongly disagree\] to 10 \[strongly agree\]) to answer ten affirmatives regarding the use of home based tDCS, with a total score range of 0-10 and a higher score indicating higher acceptability.
次要结局
- Change in Cognitive function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)(Baseline,week4)
- Change in Behavior as assessed by the Unified Huntington Disease Rating Scale (UHDRS)(Baseline,week4)
- Change in Motor function as assessed by the Unified Huntington Disease Rating Scale (UHDRS)(Baseline,week4)
- Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)(Baseline, week 2, week 4, week 8)
- Change in behavioral symptoms as assessed by the Problem Behaviours Assessment (PBA-s)(Baseline, 2 weeks of treatment, at the end of treatment (week 4) and 4 weeks post-treatment.)
- Change in apathy as assessed by the Brief Dimensional Apathy Scale (bDAS)(Baseline, week 2, week 4, week 8)
- Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA)(Baseline, week 2, week 4, week 8)
- Change in irritability as assessed by the Irritability Questionnaire(Baseline, week 2, week 4, week 8)
- Change in anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS)(Baseline, week 2, week 4, week 8)
研究者
Erin Furr Stimming
Professor
The University of Texas Health Science Center, Houston