Neuromodulation as a Therapeutic Intervention to Improve Cancer Related Fatigue and Weakness
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Fatigue task duration
研究概览
简要总结
This pilot study investigates the effectiveness of non-invasive brain stimulation (tDCS) in alleviating cancer-related fatigue (CRF) and muscle weakness. Using a randomized, double-blind crossover design, participants perform fatiguing muscle tasks with and without tDCS, and outcomes include task endurance, maximal voluntary contraction force, and neuromuscular markers. Neural mechanisms will be assessed via EEG, TMS, and MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Active tDCS
1.5-2.0 mA stimulation over motor cortex during fatigue task.
干预措施: Active tDCS + elbow flexion exercise (Device)
Sham tDCS
Stimulation for 30 seconds with ramping to mimic active sensation.
干预措施: Sham tDCS + elbow flexion exercise (Drug)
结局指标
主要结局
Fatigue task duration
时间窗: Immediately post-intervention in each experimental session.
Duration (in seconds) that participants are able to maintain a submaximal isometric contraction (20-40% of maximal voluntary contraction) during a fatigue-inducing task, performed with and without transcranial direct current stimulation (tDCS).
Muscle Strength
时间窗: Immediately after each stimulation session
Peak muscle force (in Newtons) generated during a maximal voluntary contraction (MVC) of the arm muscles, assessed immediately before and after the fatiguing isometric contraction task. Comparison is made across active tDCS and sham conditions to determine the acute effects of neuromodulation on post-fatigue strength. Force is measured using a calibrated force sensor.
次要结局
- Interpolated Twitch Force (Peripheral Fatigue Index)(Immediately after each stimulation session)
- EEG Functional Connectivity(Immediately after each stimulation session)
- EMG root mean squared amplitude(Immediately after each stimulation session)
- Motor Evoked Potential (MEP) Amplitude(Immediately after each stimulation session)
研究者
Guang Yue
Director
Kessler Foundation