A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Mean Preload Phase Duration (PLD)
研究概览
简要总结
This is a randomized, double-blind pilot clinical trial to test a novel treatment approach to rehabilitate fine motor function in individuals living with progressive multiple sclerosis (MS) using anodal transcranial direct current stimulation (tDCS) to augment manual dexterity training. Treatment will be delivered to individuals at home using a state-of-the-art remotely supervised tele-rehabilitation protocol, a major advantage for patients with respect to ease of access, feasibility, reinforcement learning and minimal burden of in clinic study visit participation. Improvements in fine motor skill will be assessed at each remote session using a novel portable grip device that measures execution and adaptation or learning of fingertip forces during grasp, which is more sensitive than standard measures of hand function.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite MS diagnosis, progressive subtype
- •9HPT score between -1.0 and -4.0 standard deviations from age-based normative data
- •Score of < 7.5 or less on the EDSS (with caregiver proxy required for those with scores of 6.5 or greater)*
- •Ability to understand the informed consent process and provide consent to participate in the study
排除标准
- •Primary neurologic, psychiatric or other medical disorder other than MS
- •Use of upper extremity Botox injection within 3 months
- •Current use of intrathecal Baclofen
- •History of seizure disorder
- •History of head trauma or medical device in head or neck
- •Clinically significant abnormality on EKG
- •Symbol Digit Modalities Test or SDMT score ≥3.0 SD from published norms
- •WRAT-4 reading level below average (<85) (estimated general intellectual function)
- •Skin disorder/sensitive near stimulation locations
研究组 & 干预措施
RS-tDCS Stimulation
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
干预措施: Active RS-tDCS +At-Home Manual Dexterity Training (Device)
RS-tDCS Stimulation
20 times 20 minute stimulation session supervised by a study technician through a videoconferencing platform, VSee
干预措施: Manual dexterity training (Other)
Sham Stimulation
20 ×20-minute sessions sham tDCS
干预措施: Sham RS-tDCS +At-Home Manual Dexterity Training (Device)
Sham Stimulation
20 ×20-minute sessions sham tDCS
干预措施: Manual dexterity training (Other)
结局指标
主要结局
Mean Preload Phase Duration (PLD)
时间窗: baseline and 30 minutes for each of 20 sessions, values averaged across sessions
(PLD) is the duration of finger contact until the onset of positive load force. It assesses the time taken to stabilize grasp and is a robust measure of grasp execution.
次要结局
未报告次要终点