Safety and Feasibility of Tele-supervised Home-based Transcranial Direct Current Stimulation in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Feasibility of repeated network-targeted multifocal tDCS at home
研究概览
简要总结
The goal of this clinical trial is to learn whether home-based transcranial direct current stimulation (tDCS) is safe and practical for people aged 40 to 70 years with Parkinson's Disease. The study aims to find out if participants can use the tDCS device at home without serious side effects and whether it is easy for them to use on their own.
Participants will first attend an in-person visit to learn how to use the tDCS device. They will then use the device at home once a day for 20 minutes over seven consecutive days. Video calls on days 2 and 3 will provide support and supervision. After each session, participants will complete brief online questionnaires about any side effects and how easy the device was to use. The study will also check if using tDCS at home improves motor symptoms in Parkinson's Disease by using a standard movement assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
Scores will be recorded on video to ensure blinding to the timepoint of clinical scores.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the diagnosis of Parkinson's disease, aged between 40 and 70, who provide verbal and written informed consent will be included. Patients should have access to a computer system for video calls and completing the questionnaires, and they must be able to use it.
排除标准
- •Psychiatric symptoms such as moderate or severe depression
- •Cranial metal implants
- •Cardiac pacemaker
- •Epilepsy, stroke
- •Substance abuse
- •Inability to adjust the neoprene cap with the electrodes independently due to movement disturbances
研究组 & 干预措施
Active tDCS
Subjects receiving active tDCS
干预措施: tDCS (Device)
结局指标
主要结局
Feasibility of repeated network-targeted multifocal tDCS at home
时间窗: 8 days.
Measures the total number of days each participant successfully completes tDCS sessions at home, aiming for seven consecutive days. Method: Daily online logs.
次要结局
- Safety of repeated network-targeted multifocal tDCS at home(8 days.)
- Questionnaires for difficulty in usability, subjective effect on motor symptoms, severity of side effects(8 days.)
- Motor outcome(8 days.)
研究者
Michael D. Fox, M.D.,Ph.D.
Director, Center for Brain Circuit Therapeutics
Brigham and Women's Hospital