NCT07197346

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Sep 2025Dec 2028

Study Start

First participant enrolled

September 1, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

September 15, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

motor learningrepetitive transcranial magnetic stimulationautonomy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

  • Intrinsic Motivation Inventory (IMI)

    Immediately post-practice on Day 1 and Day 2

  • 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

Study Arms (6)

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.

Behavioral: Self-controlled (autonomy)Device: rTMS- iTBS (Intermittent Theta-Burst Stimulation)

iTBS + Yoked

ACTIVE COMPARATOR

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

Behavioral: Yoked PracticeDevice: rTMS- iTBS (Intermittent Theta-Burst Stimulation)

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.

Device: rTMS - cTBS (Continuous Theta-Burst Stimulation)Behavioral: Self-controlled (autonomy)

cTBS + Yoked

ACTIVE COMPARATOR

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

Device: rTMS - cTBS (Continuous Theta-Burst Stimulation)Behavioral: Yoked Practice

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.

Behavioral: Self-controlled (autonomy)Device: Sham

Sham + Yoked

SHAM COMPARATOR

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

Device: ShamBehavioral: Yoked Practice

Interventions

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.

cTBS + YokedcTBS + autonomy

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.

Sham + autonomycTBS + autonomyiTBS + autonomy
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.

Sham + YokedSham + autonomy
Yoked PracticeBEHAVIORAL

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.

Sham + YokedcTBS + YokediTBS + Yoked

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.

iTBS + YokediTBS + autonomy

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Central Study Contacts

Min Tse Lee, bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 29, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
The IPD will be available after completion of the study (anticipate to be 2028/12/31) for 7 years (2035/12/31)
Access Criteria
Upon reasonable request to the principal investigator

Locations