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rTMS StimulationNCT07197346

Repetitive Transcranial Magnetic Stimulation Primed Self-controlled Practice on Motor Learning

A study testing rTMS - cTBS (Continuous Theta-Burst Stimulation), Yoked Practice and rTMS- iTBS (Intermittent Theta-Burst Stimulation) in people with rTMS Stimulation and Autonomy, run by National Taiwan University Hospital at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
rTMS Stimulation, Autonomy, Healthy Young Adults
What is being tested?
rTMS - cTBS (Continuous Theta-Burst Stimulation), Yoked Practice and rTMS- iTBS (Intermittent Theta-Burst Stimulation)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteTaiwan
Study dates
1 Sep 2025to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • School and Graduate Institute of Physical Therapy

    Taipei, 100

Other trials in Taiwan

About this study

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

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.

Read more

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.

Being tested
rTMS - cTBS (Continuous Theta-Burst Stimulation), Self-controlled (autonomy), Sham, Yoked Practice, rTMS- iTBS (Intermittent Theta-Burst Stimulation)
Keywords
motor learning, repetitive transcranial magnetic stimulation, autonomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMS - cTBS (Continuous Theta-Burst Stimulation)Device

    Continuous theta-burst stimulation (cTBS) is a patterned form of rTMS consisting of bursts of three pulses at 50Hz, repeated every 200ms (5Hz), administered continuously without breaks. In this study, cTBS is delivered over the target cortical area according to established safety guidelines (e.g., a continuous 40s train for a total of 600 pulses) at an intensity set as a percentage of the resting motor threshold. The procedure is used to induce a transient reduction in cortical excitability as a priming intervention prior to motor practice.

  • Self-controlled (autonomy)Behavioural

    Self-controlled practice is a motor learning intervention in which participants are granted autonomy to make choices about key aspects of their practice sessions (e.g., when to receive feedback, the sequence/timing of trials, or selection of specific practice parameters). This design allows participants to actively control elements of the training experience according to their preference, thereby fostering intrinsic motivation and engagement. The intervention is grounded in the OPTIMAL theory of motor learning, which highlights the role of autonomy support in enhancing learning outcomes and motivation. In this study, participants in the self-controlled practice group make their own decisions regarding practice conditions, in contrast to yoked controls who follow externally assigned parameters.

  • ShamDevice

    Sham TBS involves the application of a sham theta-burst stimulation protocol designed to mimic the sensory experience of active TBS without delivering effective magnetic pulses to the brain. This is typically achieved by angling the coil to prevent cortical stimulation. The procedure controls for placebo effects and participant expectations while ensuring blinding. The sham stimulation session matches the timing and setup of active TBS interventions but does not induce cortical excitability changes.

  • Yoked PracticeBehavioural

    Yoked practice refers to a motor learning protocol in which participants perform tasks under externally controlled practice conditions, matched to the parameters (e.g., feedback) of a paired participant from a self-controlled practice group. This design removes participant autonomy over practice choices, allowing comparison between self-controlled and externally controlled practice to evaluate the effects of autonomy on motor learning and motivation.

  • rTMS- iTBS (Intermittent Theta-Burst Stimulation)Device

    Intermittent theta-burst stimulation (iTBS) is a patterned form of repetitive transcranial magnetic stimulation (rTMS) consisting of bursts of three pulses at 50Hz, repeated every 200ms (5Hz). In this study, iTBS is delivered over the target cortical area using standard protocols (e.g., 2s trains of TBS repeated every 10s for a total of 600 pulses) at an intensity set as a percentage of the resting motor threshold. The procedure aims to facilitate cortical excitability as a priming intervention prior to motor practice.

Study groups in NCT07197346
Study groupRoleWhat they receive
iTBS + autonomyExperimentalParticipants 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.
Receives: Behavioral: Self-controlled (autonomy); Device: rTMS- iTBS (Intermittent Theta-Burst Stimulation)
iTBS + YokedActive comparatorParticipants receive iTBS priming, then perform motor practice with yoked (non-self-controlled) parameters matched to a self-controlled participant.
Receives: Behavioral: Yoked Practice; Device: rTMS- iTBS (Intermittent Theta-Burst Stimulation)
cTBS + autonomyExperimentalParticipants 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.
Receives: Device: rTMS - cTBS (Continuous Theta-Burst Stimulation); Behavioral: Self-controlled (autonomy)
cTBS + YokedActive comparatorParticipants receive cTBS priming, then perform motor practice with yoked practice parameters.
Receives: Device: rTMS - cTBS (Continuous Theta-Burst Stimulation); Behavioral: Yoked Practice
Sham + autonomySham comparatorParticipants 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.
Receives: Behavioral: Self-controlled (autonomy); Device: Sham
Sham + YokedSham comparatorParticipants receive sham TBS priming, then perform motor practice with yoked parameters.
Receives: Device: Sham; Behavioral: Yoked Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Secondary outcomes (3)
  1. Intrinsic Motivation Inventory (IMI)

    Total IMI score assessing task-related intrinsic motivation (e.g., interest/enjoyment, perceived competence, effort/importance, perceived choice). Specify version, item count, and response scale (e.g., 1-7 Likert). Higher scores indicate higher intrinsic motivation.

    Measured: Immediately post-practice on Day 1 and Day 2

  2. Change in Corticospinal Excitability/Inhibition

    We record Motor Evoked Potential (MEP) Amplitude, Resting and Active Motor Thresholds, Cortical Silent Period (CSP), and Short-Interval Intracortical Inhibition (SICI) via TMS. Resting motor threshold (RMT) and active motor threshold (AMT) determined via standard procedures to anchor stimulation intensities. Peak-to-peak MEP amplitude recorded from the target muscle using single-pulse TMS at fixed intensity relative to resting motor threshold (e.g., 120% RMT). CSP duration measured during tonic contraction using suprathreshold single-pulse TMS. Longer CSP reflects stronger GABA-B-mediated inhibition. Paired-pulse TMS determines SICI with a subthreshold conditioning stimulus followed by a suprathreshold test stimulus at a short interstimulus interval (e.g., 2-3ms). Lower conditioned/test ratio indicates stronger GABA-A-mediated inhibition.

    Measured: At baseline before priming, immediately post-practice on Day 2, and on Day 7

  3. Change in Error Estimation Accuracy (EE)

    Subjective estimation of own motor performance error recorded after each trial/block. EE accuracy is defined as the absolute difference between the participant's estimated error and the actual task error (e.g., RMSE) for the same trial/block. Lower values indicate more accurate metacognitive estimation. Outcome is the change from baseline calibration to post-practice.

    Measured: Post-practice on Day 2, and after tests on Day7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start1 Sep 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07197346
Sponsor's protocol ID
202506021RINB
Status last verified
Sep 2025
First submitted
15 Sep 2025
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The IPD collected in this study will be available to other researchers upon reasonable request to the principal investigator after the study has been completed.

Questions about this trial

What is this clinical trial studying?

A study testing rTMS - cTBS (Continuous Theta-Burst Stimulation), Yoked Practice and rTMS- iTBS (Intermittent Theta-Burst Stimulation) in people with rTMS Stimulation and Autonomy, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Motor Task Accuracy (Root Mean Square Error, RMSE) (time frame: Throughout practice on Day1 and Day2, immediately post-practice on Day2, and at the retention and transfer tests on Day 7.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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