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临床试验/NCT07197346
NCT07197346进行中(未招募)不适用

The Effects of Repetitive Transcranial Magnetic Stimulation Primed Self-controlled Practice on Motor Learning and Motivation

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
72
试验地点
1
主要终点
Change in Motor Task Accuracy (Root Mean Square Error, RMSE)

研究概览

简要总结

This study aims to investigate the additive effects of combining self-controlled practice with repetitive transcranial magnetic stimulation (rTMS) pretreatment on motivation enhancement and motor learning performance in healthy young adults. According to the "Optimizing Performance Through Intrinsic Motivation and Attention for Learning" (OPTIMAL) theory, numerous studies have demonstrated that providing learners with autonomy during practice can facilitate intrinsic motivation and motor learning. However, self-controlled practice alone may have limited effects, and further interventions may be required to amplify learning outcomes.

In recent years, non-invasive brain stimulation techniques-particularly high-frequency (facilitatory) rTMS applied to the dorsolateral prefrontal cortex (DLPFC)-have been shown to enhance motivational drive and explicit learning performance by strengthening the connectivity of the DLPFC-midbrain dopamine pathway. For example, 10 Hz high-frequency stimulation can significantly improve learners' accuracy and motivation. Interestingly, several sequence learning studies have found that low-frequency (inhibitory) rTMS, when used as a priming intervention, can instead enhance implicit procedural learning. This effect may occur because inhibiting the lateral prefrontal cortex reduces its top-down suppression of implicit learning systems, thereby releasing procedural learning potential.

Based on the theory of metaplasticity, applying facilitatory or inhibitory stimulation beforehand can alter the threshold of synaptic plasticity, thus influencing subsequent learning outcomes. Therefore, this study designed two DLPFC pretreatments-facilitatory and inhibitory-and combined them with self-controlled practice to systematically examine the interaction between different stimulation protocols on motivation and motor learning.

This cross-sectional experiment plans to recruit 72 healthy participants aged 20 or older, randomly assigned to one of six groups: (1) facilitatory rTMS + self-controlled practice, (2) facilitatory rTMS + yoked control, (3) inhibitory rTMS + self-controlled practice, (4) inhibitory rTMS + yoked control, (5) sham rTMS + self-controlled practice, and (6) sham rTMS + yoked control.

The experiment will last for seven days. On Day 1, participants will complete baseline testing, followed by facilitatory rTMS, inhibitory rTMS, or sham stimulation over the DLPFC. Immediately afterward, they will engage in a trajectory-tracking learning task (manipulating a joystick to reproduce a sine-wave pattern). After practice, participants will complete a motivation assessment. During the trajectory-tracking task, the self-controlled group can choose when to receive feedback to adjust their learning, whereas the yoked control group will receive feedback at time points matched to their paired counterpart.

On Day 2, participants will again receive the assigned rTMS (facilitatory, inhibitory, or sham), complete the trajectory-tracking task, and undergo a motivation assessment. After a five-minute rest, they will perform retention and transfer tests, followed by TMS measurement of cortical excitability. On Day 7, participants will return to the laboratory to complete another retention and transfer test, along with cortical excitability measurement via TMS.

The primary behavioral outcomes are the root mean square error (RMSE) and error estimation (EE) in the trajectory-tracking task. Motivation will be assessed using the Intrinsic Motivation Inventory (IMI). As there have been no prior studies combining DLPFC rTMS pretreatment with practice autonomy, the results of this experimental design are expected to provide new insights and references for enhancing motor learning ability in healthy adults.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy adults aged 18-35 years
  • •Right-handed (per Edinburgh Handedness Inventory)
  • •Normal or corrected-to-normal vision and hearing
  • •Eligible for non-invasive brain stimulation per safety screening (no contraindications to TMS)
  • •Able to understand study procedures and provide written informed consent in Chinese
  • •Willing to comply with all study visits and tasks, including TBS/rTMS and motor practice
  • •For yoked pairing: able to be matched to a counterpart participant for practice parameters

排除标准

  • •History of epilepsy, seizures, or unexplained fainting; family history of epilepsy in first-degree relatives
  • •Any intracranial metal or implanted medical devices (e.g., cochlear implant, deep brain stimulator, aneurysm clips); non-removable metallic objects in head/neck
  • •Cardiac pacemaker or other implanted electronic devices
  • •Current or past major neurological or psychiatric disorders (e.g., stroke, traumatic brain injury, multiple sclerosis, major depression, bipolar disorder, schizophrenia)
  • •Current use of medications lowering seizure threshold or affecting cortical excitability (e.g., tricyclic antidepressants, bupropion, clozapine, lithium, stimulant or sedative-hypnotic abuse); or unstable psychotropic regimens
  • •Active migraine with aura or chronic severe headaches
  • •Pregnancy or planning pregnancy during participation; breastfeeding (if your site policy excludes)
  • •Substance or alcohol use disorder within the past 12 months; positive alcohol/drug screen on visit days
  • •Sleep deprivation (<5 hours) on the day before stimulation, or excessive caffeine (>400 mg) within 6 hours pre-stimulation
  • •Dermatologic conditions or open wounds at stimulation or EMG/electrode sites
  • •Prior extensive training on the specific motor task used in this study (risk of ceiling effects)
  • •Concurrent participation in another interventional study or received brain stimulation (TMS/tDCS) within the past 3 months
  • •Any condition that, in the investigator's judgment, makes participation unsafe or data unreliable

研究组 & 干预措施

iTBS + autonomy

Experimental

Participants receive intermittent theta-burst stimulation (iTBS) as priming, followed by self-controlled practice of a joystick task. The participants will be able to self-select the trials for receiving feedback.

干预措施: Self-controlled (autonomy) (Behavioral)

iTBS + autonomy

Experimental

Participants receive intermittent theta-burst stimulation (iTBS) as priming, followed by self-controlled practice of a joystick task. The participants will be able to self-select the trials for receiving feedback.

干预措施: rTMS- iTBS (Intermittent Theta-Burst Stimulation) (Device)

iTBS + Yoked

Active Comparator

Participants receive iTBS priming, then perform motor practice with yoked (non-self-controlled) parameters matched to a self-controlled participant.

干预措施: rTMS- iTBS (Intermittent Theta-Burst Stimulation) (Device)

iTBS + Yoked

Active Comparator

Participants receive iTBS priming, then perform motor practice with yoked (non-self-controlled) parameters matched to a self-controlled participant.

干预措施: Yoked Practice (Behavioral)

cTBS + autonomy

Experimental

Participants receive continuous theta-burst stimulation (cTBS) as priming, followed by self-controlled practice of a joystick task. The participants will be able to self-select the trials for receiving feedback.

干预措施: rTMS - cTBS (Continuous Theta-Burst Stimulation) (Device)

cTBS + autonomy

Experimental

Participants receive continuous theta-burst stimulation (cTBS) as priming, followed by self-controlled practice of a joystick task. The participants will be able to self-select the trials for receiving feedback.

干预措施: Self-controlled (autonomy) (Behavioral)

cTBS + Yoked

Active Comparator

Participants receive cTBS priming, then perform motor practice with yoked practice parameters.

干预措施: Yoked Practice (Behavioral)

Sham + autonomy

Sham Comparator

Participants receive sham TBS stimulation as priming, followed by self-controlled practice of a joystick task. The participants will be able to self-select the trials for receiving feedback.

干预措施: Self-controlled (autonomy) (Behavioral)

Sham + autonomy

Sham Comparator

Participants receive sham TBS stimulation as priming, followed by self-controlled practice of a joystick task. The participants will be able to self-select the trials for receiving feedback.

干预措施: Sham (Device)

Sham + Yoked

Sham Comparator

Participants receive sham TBS priming, then perform motor practice with yoked parameters.

干预措施: Sham (Device)

Sham + Yoked

Sham Comparator

Participants receive sham TBS priming, then perform motor practice with yoked parameters.

干预措施: Yoked Practice (Behavioral)

cTBS + Yoked

Active Comparator

Participants receive cTBS priming, then perform motor practice with yoked practice parameters.

干预措施: rTMS - cTBS (Continuous Theta-Burst Stimulation) (Device)

结局指标

主要结局

Change in Motor Task Accuracy (Root Mean Square Error, RMSE)

时间窗: Throughout practice on Day1 and Day2, immediately post-practice on Day2, and at the retention and transfer tests on Day 7.

Root Mean Square Error (RMSE) on the target motor task, computed across trials within each assessment block to quantify spatial/temporal accuracy. RMSE is calculated as the square root of the mean of squared deviations between the participant's performance trajectory/output and the predefined target/ideal trajectory/output. Lower RMSE indicates better accuracy. The primary endpoint is the change from baseline, defined as RMSE at the post-practice assessment minus RMSE at baseline. If multiple trials are collected per block, RMSE will be averaged across trials to yield a single value per time point. Outliers and artifact-contaminated trials will be handled according to a prespecified quality-control procedure \[e.g., exclude trials with \>3 SD from block mean or device-detected artifacts\], and the number of excluded trials will be recorded.

次要结局

  • Change in Corticospinal Excitability/Inhibition(At baseline before priming, immediately post-practice on Day 2, and on Day 7)
  • Change in Error Estimation Accuracy (EE)(Post-practice on Day 2, and after tests on Day7)
  • Intrinsic Motivation Inventory (IMI)(Immediately post-practice on Day 1 and Day 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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