Synergistic Effects of Aerobic Exercise and Repetitive Transcranial Magnetic Stimulation on Brain Connectivity and Pain Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cortical connectivity
研究概览
简要总结
Participants attend two sessions, one week apart, as part of a randomized crossover study involving either an active or sham intervention. Both sessions follow identical procedures, except for the TMS intervention. Each session includes: three pain pressure threshold measurements, two TMS-EEG recordings, 30 minutes of moderate-intensity exercise on a stationary bike, and two resting-state EEG recordings. Repetitive TMS is administered as an active intervention in one session and as a sham in the other, and more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomization is applied only at the participant level: each participant is randomly assigned to start with either the active or sham condition, with the alternate condition administered in the second session. The study is single-blinded, meaning that participants are blinded to the intervention type (active vs. sham), while the investigators administering the sessions are aware of the allocation.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women aged 18-60 years
- •Speak and understand English
排除标准
- •Pregnant or breastfeeding
- •Regular use of cannabis, opioids, or other drugs
- •Chronic pain (i.e., pain most days within the last three months)
- •Current or previous neurologic or musculoskeletal illnesses, psychiatric diagnoses, or other ilnesses (e.g., brain or spinal cord injuries, degenerative neurological disorders, major depression, cardiovascular disease, chronic lung disease, etc.)
- •Current regular use of analgesic medication or other medication which may affect the trial (including paracetamol and NSAIDs)
- •Recent history of acute pain (i.e., episodic migraine attacks or pain in the lower limbs)
- •Abnormally disrupted sleep in 24 hours preceding experiment
- •Contraindications to TMS application (history of epilepsy, metal implants in head or jaw, etc.)
- •Unable to fulfil the criteria of the "Transcranial Magnetic Stimulation Adult Safety Screen"
- •Presence of implanted hearing aids or metal implants on the face, including permanent makeup or tattoos.
- •Lack of ability to cooperate
研究组 & 干预措施
Aerobic Exercise & rTMS
Each session includes identical procedures, except for the type of repetitive transcranial magnetic stimulation (rTMS) administered. Participants receive active rTMS in one session and sham rTMS in the other, with the order randomized. The intervention arm includes the following procedures (not in order):
Pain pressure threshold (PPT) assessments performed three times per session
TMS-EEG data collection conducted at two time points per session
30 minutes of moderate-intensity cycling on a stationary bike
Resting-state EEG recorded twice per session
Repetitive TMS intervention: active stimulation in one session, sham stimulation in the other
干预措施: repetitive Transcranial Magnetic Stimulation (Device)
Aerobic Exercise & rTMS
Each session includes identical procedures, except for the type of repetitive transcranial magnetic stimulation (rTMS) administered. Participants receive active rTMS in one session and sham rTMS in the other, with the order randomized. The intervention arm includes the following procedures (not in order):
Pain pressure threshold (PPT) assessments performed three times per session
TMS-EEG data collection conducted at two time points per session
30 minutes of moderate-intensity cycling on a stationary bike
Resting-state EEG recorded twice per session
Repetitive TMS intervention: active stimulation in one session, sham stimulation in the other
干预措施: Sham repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Cortical connectivity
时间窗: Day 2
Global and local mean field amplitude
次要结局
- Cortical excitability(Day 2)
- Borg-20(Day 2)
- Pain Pressure Threshold(Day 2)
- Pain Numerical Rating Scale (NRS)(Day 2)
研究者
Enrico De Martino
Principal Investigator
Aalborg University