Home-based TDCS for Cognitive and Behavioral Symptoms in Huntington's Disease: a Pilot Feasibility and Mechanistic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of Participants that met Inclusion Criteria
研究概览
简要总结
The researchers hope to find out effects of transcranial direct current stimulation (tDCS) sessions on the behavioral symptoms of Huntington's Disease. If participants are eligible to continue, they will be provided a device to administer the tDCS for 30 minutes each day and be asked to answer questions with the study staff . Participants will be asked to return to the study center for follow ups and to undergo additional cognitive tests and questionnaires. Participants will also be asked to answer questionnaires via a web conferencing platform (Zoom) during the course of the study. Caregivers of the participants will be asked to answer questionnaires to collect more information about the participants.
详细描述
This clinical trial will investigate the effects of transcranial direct current stimulation (tDCS) over cognitive and behavioral symptoms of patients with Huntington's disease (HD). The study will also investigate underlying neurobiological mechanisms of tDCS in HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Investigator)
盲法说明
Patients will be blinded throughout the trial. As the application of tDCS electrical current over the skin can be perceived by the participants, the study team will employ a sham condition that has been shown to be reliable and indistinguishable from active treatment in previous clinical trials published in the available scientific literature. An individual on the study team will be delegated to randomize and program and re-program devices. Participants will act as their own control. The researcher supervising the stimulation will be blinded to the intervention the participant is receiving.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals aged 18-85 years with confirmed HD mutation 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 criteria, also known as the UHDRS total functional capacity (TFC) scale (Bates, Tabrizi, and Jones 2014);
- •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.
- •Ability of subject to understand and the willingness to sign a written informed consent document.
- •Have a caregiver willing to be present during tDCS sessions and answer questionnaires.
- •An adult who serves as an unpaid caregiver for an individual enrolled in the study as interpreted by the PI or delegate physician.
- •Adequate cognitive capacity to provide verbal consent to participate in the caregiver arm of the study.
- •Adequate reading, writing, hearing, and verbal capacity to provide collateral information about the study participant as well as answer questions related to their health and care.
排除标准
- •Unstable medical conditions (e.g. unstable angina, uncontrolled diabetes and hypertension, advanced cancer, etc.);
- •History of epilepsy;
- •Clinical diagnosis of major cognitive disorder (i.e., dementia);
- •Have risk of suicidal behavior, defined as any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the 3 months prior to screening (Posner et al. 2011);
- •Being an active participant in other therapeutic clinical trial;
- •Determined to be incapable of consent per PMH or via assessment by the study staff at time of consent.
- •Participant has a pacemaker or any other implanted device/material contraindicated in the use of tDCS per current labeling requirements.
- •1. Any individual who does not meet all the inclusion criteria
研究组 & 干预措施
Active TDCS treatment
The active-tDCS treatment will consist of a constant 2mA current applied during 30-minute sessions with a 30 second ramp up and ramp down at the start and end of the stimulation.
干预措施: Transcranial direct current stimulation (tDCS) (Device)
Sham TDCS treatment
Sham-tDCS treatment will consist of the same montage as the active TDCS with the built-in function of the device that has been shown to be indistinguishable from the active treatment in previous trials described in the literature.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Percentage of Participants that met Inclusion Criteria
时间窗: Baseline
Percentage of participants screened that met Inclusion Criteria
Percentage of Participants that Agreed to Randomization
时间窗: Baseline
Percentage of eligible participants that were screened and met eligibility that agreed to be randomized.
Completed period 1 of study
时间窗: Day 13
Percentage of participants who completed first 2 weeks of treatment or sham
Completed period 2 of study
时间窗: Day 35
Percentage of participants that completed both the first period, the washout period and the second period of the study
Completion of study to last visit
时间窗: Day 36 (or day 37)
Percentage of participants that completed study from randomization to tDCS/Sham crossed over to alternate treatment/sham and returned for final visit
TDCS Acceptability Scale
时间窗: Day 14 and Day 35
This Likert scale scores 10 items for user acceptability. Each item is scored from 0-10 giving. Some items have negative valence, in which lower scores indicate higher acceptability. An averaged of adjusted scores for all items is calculated to produce a global acceptability score ranging from 0 to 10. A higher score on the global score indicates better acceptability.
tDCS Side Effects Scale
时间窗: Day 8, 14, 29 and 35
This Likert scale includes 10 items scored from 0-10 for possible side effects. The first 9 items include a list of possible side effects and the last item is free field for the report of any additional side effects. Lower scores indicate less intensity of side effects. Scores will be reported for each individual item.
次要结局
- Problem Behaviors Assessment Scale (PBA-S)(Baseline, and days 14, 22, and 35.)
- Frontal Assessment Battery (FAB)(Baseline, and days 14 and 35.)