Effects of rTMS on Brain Plasticity and Motor Learning in Healthy People.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Motor performance in consolidation test
研究概览
简要总结
Recent studies have identified new neurobiological biomarker (i.e. functional connectivity of the parietal cortex) of motor learning among healthy people. This enables to refine our current model of motor learning wherein specific cortical processes are key factors for motor acquisition. Furthermore, recent evidence suggests that new technical approaches such as repetitive magnetic stimulation (rTMS) can efficiently influence this key factor. However, up to now, no rTMS studies have target this new biomarker. Therefore, the effect of rTMS are unknown. Hence, the investigators want to develop a new rTMS setup able to induce specific brain processes in healthy individuals that are likely to benefit. This has the potential to obtain critical information in order to improve treatment of motor re-learning in patients with neurological diseases.
详细描述
Participants will participate in 1 session of neuronavigated (TMS Navigator, Localite, Schloss Birlinghoven, D-53757, Sankt Augustin, Germany ) iTBS (patterned form of rTMS) coupled with motor learning. Participants will be randomly assigned to one of 2 groups: real iTBS over parietal cortex and sham iTBS over the parietal cortex.
One day before (Day1) and after the motor learning (Day 2), participants will undergo high-density 128-channel resting state electroencephalography (EEG) and motor evoked potential (MEP) in order to characterize the effects of rTMS on our markers of plasticity. Performance on the task will be measure immediately after learning (Day 2) and again 24h later (Day 3) in order to test for retention and offline consolidation (time and errors). The task will consist in realizing a computerized mirror-drawing task, in which right-left movements of the mouse were reversed on the screen.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •man or woman aged between 18-40 years,
- •ability to give informed consent,
- •ability to follow protocol instructions,
- •normal or corrected-to-normal vision,
排除标准
- •history of epileptic seizure (ci. TMS),
- •skull breach (ci. TMS),
- •metallic object in the brain (ci. TMS),
- •pacemaker (ci. TMS),
- •severe co-morbidity (ex, traumatic, rheumatologic, neurodegenerative diseases),
- •pregnancy.
研究组 & 干预措施
Intermittent theta burst stimulation
Volunteers will be submitted to non-invasive parietal stimulation before a mirror drawing task.
A transcranial magnetic stimulator (MagPro X100, Medtronic Functional Diagnostics, Skovlunde, Denmark) will deliver interrmittent bursts of bipolar magnetic pulses exerting an excitation on the underlying brain tissue (iTBS). The stimulation coil will be placed over the parietal cortex. Stimulation consisted of a burst of three pulses administered at 50Hz, repeated at a frequency of 5Hz, delivered in 2 s trains followed by an 8 s interval for a total of 600 pulses12. Stimulation intensity was set at 70% of RMT.
Each session will consist of two spaced neuronavigated iTBS applications, separated by 15 minutes.
干预措施: rTMS device (Device)
Sham intermittent theta burst stimulation
For sham iTBS, the protocol is the same, except the sham coil produces no magnetic field.
干预措施: rTMS device (Device)
结局指标
主要结局
Motor performance in consolidation test
时间窗: after training (Day 3)
Difference in error rate and speed improvement in active and sham groups (learned task)
次要结局
- Resting state EEG connectivity in active and sham groups(Before (Day 1) and after training (Day 2))
- Motor Evoked Potential (MEPs) Amplitudes (peak to peak)(Before (Day 1) and after training (Day 2))
研究者
Pierre Nicolo
Principal Investigator
University of Geneva, Switzerland