Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8.
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are:
- Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8?
- Stage 2: Is there a change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score?
In stage 2, researchers will compare the group receiving the stimulation vs the group receiving a sham stimulation to see if there is a difference in motor cortex activity and in the ALSFRS-R score
Participants will receive either:
- the TPS treatment
- a sham TPS treatment
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, Investigator)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of sporadic ALS (definite or clinically probable) as defined by the World Federation of Neurology revised El Escorial criteria
- •SVC of 50% or greater of estimated measure and presence of measurable motor evoked potential
- •21 to 80 years old and male or female
排除标准
- •patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below
结局指标
主要结局
Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8.
时间窗: baseline to week 8
Change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score
时间窗: baseline to week 24
The ALS Functional Rating Scale-Revised Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Higher scores mean a better outcome.
次要结局
- Change plasma neurofilament light chain (NfL) levels(baseline to week 4 and 8)
- Changes in muscle strength, assessed by the Medical Research Council (MRC) sum score(baseline to week 4 and 8)
- Changes in hand-held dynamometry(baseline to week 8)
- Differences (treated vs sham) and change in the slow vital capacity (SVC)(from baseline to month 6)
- Differences (treated vs sham) and change in plasma NfL levels(baseline to month 6)
- Change in Motor Evoked Potential (MEP) Amplitudes(baseline to week 4 and 8)
- Change in Resting Motor Threshold(baseline to week 4 and 8)
- Change in Intra-Cortical Facilitation(baseline to week 4 and 8)