Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Two Cerebellar Targets (Lobule VIII vs. CRUS I/II)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Resting-State Functional Connectivity (RSFC) Measured by functional Magnetic Resonance Imaging (fMRI, expressed as Fisher's z-transformed correlation coefficients) within Cerebellar-Thalamo-Frontal and Cerebellar-Parieto-Motor Networks.
研究概览
简要总结
The purpose of this study is to understand how different areas of the cerebellum (a part of the brain) control different functions and how they can be influenced by non-invasive brain stimulation.
While researchers know that repetitive Transcranial Magnetic Stimulation (rTMS) can have positive effects on conditions like stroke and schizophrenia, they do not yet fully understand which specific stimulation settings work best or which exact parts of the cerebellum should be targeted for different symptoms.
This study compares the effects of stimulation on two specific regions:
- Lobule VIII: Linked to movement and motor learning.
- CRUS I/II: Linked to attention, thinking (cognition), and predicting the timing of events.By comparing these areas, researchers hope to gain the information needed to develop better treatments for neurological and psychiatric disorders.
This is a randomized, double-blind study involving 40 healthy volunteers. Participants will be split into two groups:
- Group 1: Receives "exciting" (activity-increasing) stimulation.
- Group 2: Receives "inhibiting" (activity-decreasing) stimulation.
Each participant will attend three different test sessions in a random order:
- rTMS targeting Lobule VIII
- rTMS targeting CRUS I/II
- Placebo (Sham) stimulation that looks and feels like the real thing but does not affect the brain.
During each session, researchers will use brain imaging (fMRI) and computerized tasks to measure changes in brain connectivity and performance in motor and cognitive activities.
There is no direct medical benefit to the participants. However, the results will help scientists create better therapies for patients with brain-related health issues The risks are considered minimal. Common side effects of rTMS include temporary mild headaches or a clicking sound during stimulation. MRI scans can sometimes cause mild discomfort or a feeling of closed-in spaces (claustrophobia). Researchers have put safety measures in place, such as hearing protection and constant medical supervision during scans, to minimize these risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the personnel specifically operating the rTMS platform will have knowledge of the type of stimulation (active target VIII, active target Crus I/II, or Sham) being administered to each participant. This ensures that both the volunteer and the research team evaluating the behavioral and imaging data remain unaware of the intervention assignment until the end of the analysis phase.
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
- •Subject, male or female, aged between 18 and 60 years inclusive
- •Subject affiliated with or a beneficiary of a social security health insurance scheme
- •Subject has dated and signed the informed consent form prior to the start of any trial-related procedures
- •For women of childbearing potential, a negative urinary pregnancy test and the use of effective contraception throughout the duration of the study
排除标准
- •Subject with substance use disorders (as defined by the DSM-5)
- •Subject having taken benzodiazepines and related compounds (within the period preceding inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (within the 2 months preceding inclusion), or hallucinogenic substances (within the period preceding inclusion, for a duration equivalent to 5 half-lives of the product)
- •Subject suffering from a neurological pathology or sequelae
- •Subject with Attention-Deficit/Hyperactivity Disorder (ADHD)
- •Subject with Borderline Personality Disorder
- •Subject presenting with disabling sensory impairments, specifically a visual acuity (corrected, if applicable) < 0.8 (due to the use of visual materials; Freiburg Vision Test, Bach 1996; verified during an examination at the screening visit)
- •Subject deprived of liberty or under legal protection
- •Subject under guardianship or trusteeship
- •Pregnant or breastfeeding woman (verified by a urinary test at the screening visit)
- •Subject within an exclusion period defined by another clinical study or participating in a study likely to impact the results of the research
- •Subject presenting a contraindication for fMRI or rTMS: presence of non-removable ferromagnetic bodies, prostheses, pacemakers, implanted medication pumps, vascular clips or stents, heart valves or ventricular shunts, certain intracerebral clips, cochlear implants, history of seizures (epilepsy), or skin breach/pathology at the point of contact with the electrodes
- •Subject with a history of major neurological or psychiatric disease with current psychotropic medication (i.e., antipsychotics, benzodiazepines and related compounds, or hypnotics)
研究组 & 干预措施
4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory
干预措施: Active rTMS - Lobule VIII (Device)
4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory
干预措施: Active rTMS - Crus I/II (Device)
4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory
干预措施: Sham rTMS (Device)
4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory
干预措施: Active rTMS - Lobule VIII (Device)
5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory
干预措施: Active rTMS - Crus I/II (Device)
5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory
干预措施: Sham rTMS (Device)
5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory
干预措施: Active rTMS - Lobule VIII (Device)
6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory
干预措施: Active rTMS - Crus I/II (Device)
6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory
干预措施: Sham rTMS (Device)
6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory
Participants receive active rTMS to Lobule VIII in the first session, followed by active rTMS to Crus I/II in the second, and Sham stimulation in the third.
干预措施: Active rTMS - Lobule VIII (Device)
1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory
Participants receive active rTMS to Lobule VIII in the first session, followed by active rTMS to Crus I/II in the second, and Sham stimulation in the third.
干预措施: Active rTMS - Crus I/II (Device)
1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory
Participants receive active rTMS to Lobule VIII in the first session, followed by active rTMS to Crus I/II in the second, and Sham stimulation in the third.
干预措施: Sham rTMS (Device)
1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory
Participants receive active rTMS to Lobule VIII in the first session, followed by active rTMS to Crus I/II in the second, and Sham stimulation in the third.
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory
Participants receive active rTMS to Lobule VIII, followed by Sham stimulation, and finally active rTMS to Crus I/II.
干预措施: Active rTMS - Lobule VIII (Device)
2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory
Participants receive active rTMS to Lobule VIII, followed by Sham stimulation, and finally active rTMS to Crus I/II.
干预措施: Active rTMS - Crus I/II (Device)
2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory
Participants receive active rTMS to Lobule VIII, followed by Sham stimulation, and finally active rTMS to Crus I/II.
干预措施: Sham rTMS (Device)
2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory
Participants receive active rTMS to Lobule VIII, followed by Sham stimulation, and finally active rTMS to Crus I/II.
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory
Participants receive active rTMS to Crus I/II, followed by active rTMS to Lobule VIII, and finally Sham stimulation.
干预措施: Active rTMS - Lobule VIII (Device)
3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory
Participants receive active rTMS to Crus I/II, followed by active rTMS to Lobule VIII, and finally Sham stimulation.
干预措施: Active rTMS - Crus I/II (Device)
3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory
Participants receive active rTMS to Crus I/II, followed by active rTMS to Lobule VIII, and finally Sham stimulation.
干预措施: Sham rTMS (Device)
3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory
Participants receive active rTMS to Crus I/II, followed by active rTMS to Lobule VIII, and finally Sham stimulation.
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory
Participants receive active rTMS to Crus I/II, followed by Sham stimulation, and finally active rTMS to Lobule VIII.
干预措施: Active rTMS - Lobule VIII (Device)
4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory
Participants receive active rTMS to Crus I/II, followed by Sham stimulation, and finally active rTMS to Lobule VIII.
干预措施: Active rTMS - Crus I/II (Device)
4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory
Participants receive active rTMS to Crus I/II, followed by Sham stimulation, and finally active rTMS to Lobule VIII.
干预措施: Sham rTMS (Device)
4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory
Participants receive active rTMS to Crus I/II, followed by Sham stimulation, and finally active rTMS to Lobule VIII.
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory
Participants receive Sham stimulation first, followed by active rTMS to Lobule VIII and active rTMS to Crus I/II.
干预措施: Active rTMS - Lobule VIII (Device)
5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory
Participants receive Sham stimulation first, followed by active rTMS to Lobule VIII and active rTMS to Crus I/II.
干预措施: Active rTMS - Crus I/II (Device)
5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory
Participants receive Sham stimulation first, followed by active rTMS to Lobule VIII and active rTMS to Crus I/II.
干预措施: Sham rTMS (Device)
5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory
Participants receive Sham stimulation first, followed by active rTMS to Lobule VIII and active rTMS to Crus I/II.
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory
Participants receive Sham stimulation first, followed by active rTMS to Crus I/II and active rTMS to Lobule VIII
干预措施: Active rTMS - Lobule VIII (Device)
6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory
Participants receive Sham stimulation first, followed by active rTMS to Crus I/II and active rTMS to Lobule VIII
干预措施: Active rTMS - Crus I/II (Device)
6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory
Participants receive Sham stimulation first, followed by active rTMS to Crus I/II and active rTMS to Lobule VIII
干预措施: Sham rTMS (Device)
6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory
Participants receive Sham stimulation first, followed by active rTMS to Crus I/II and active rTMS to Lobule VIII
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory
干预措施: Active rTMS - Lobule VIII (Device)
1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory
干预措施: Active rTMS - Crus I/II (Device)
1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory
干预措施: Sham rTMS (Device)
1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory
干预措施: Active rTMS - Lobule VIII (Device)
2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory
干预措施: Active rTMS - Crus I/II (Device)
2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory
干预措施: Sham rTMS (Device)
2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory
干预措施: Active rTMS - Lobule VIII (Device)
3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory
干预措施: Active rTMS - Crus I/II (Device)
3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory
干预措施: Sham rTMS (Device)
3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory
干预措施: Cognitive and Motor Assessment Battery (Behavioral)
结局指标
主要结局
Change in Resting-State Functional Connectivity (RSFC) Measured by functional Magnetic Resonance Imaging (fMRI, expressed as Fisher's z-transformed correlation coefficients) within Cerebellar-Thalamo-Frontal and Cerebellar-Parieto-Motor Networks.
时间窗: Baseline (Pre-stimulation) and 1-hour post-stimulation
Functional imaging data will be pre-processed according to standard procedures: slice-timing correction, intra-run spatial realignement, inter-run realignement, distortion and motion artifact correction, band-pass filtering to remove physiological noise, and normalization into the MNI common space, followed by smoothing using FSL and SPM12 software.Subsequently, the signal within the networks of interest will be extracted using the "Conn" toolbox and compared using a General Linear Model (GLM). Connectivity maps will be generated from specific "seed" regions of interest (Crus I/II and lobule VIII), where each voxel value corresponds to the correlation with the seed region.
次要结局
未报告次要终点