An interventional study of Theta burst transcranial magnetic stimulation and Sham theta burst transcranial magnetic stimulation in Basic Science, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Indiana University · Not applicable, Interventional, and Basic science
The purpose of this study is to understand how the different regions of the brain affect our sense of limbs in space (proprioception) and in turn our hand movements (motor skill learning). This information might help us one day to generate better rehabilitation protocols to help patients with movement deficits.
Moving our hands accurately, and learning new movement skills, depends on accurate sensory information. One of the sensory inputs which is crucial to make accurate movements is proprioception (sense of our limbs in space). Failure in estimating hand position results in inaccurate movement, raising the potential for accidents and injuries, but how the healthy brain carries out these functions, and how they could be strengthened in populations with sensory and motor deficits (e.g. stroke), is unknown. With greater understanding of these processes in the healthy brain, it may one day be possible to develop rehabilitation strategies that target a patient's unique mix of sensory and motor deficits.
A robust way to identify whether a brain region plays a role in a behavior is to temporarily modulate its excitability in healthy people using non-invasive brain stimulation. This is commonly done in research with a short sequence of low-intensity transcranial magnetic stimulation (TMS), also known as repetitive TMS (rTMS). rTMS is used clinically to treat conditions such as depression and is considered very low risk provided the generally accepted screening criteria are met. In the research setting, this technique is widely used not only in healthy adults (as in this study) but also in children and people with concussion, stroke, Parkinson's disease, and more.
In separate groups of subjects, we will use rTMS over one of several brain regions of interest before the subject In separate groups of subjects, we will use a 40-second sequence of rTMS called continuous theta burst stimulation (cTBS) over one of several brain regions of interest before the subject performs performs proprioceptive and skill learning tasks known to involve sensory and motor skill (learning). If performance of the task is affected by rTMS for a given group (relative to the sham, or control, group), it means that brain region plays some role in that type of proprioceptive or skill task.
Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Theta burst transcranial magnetic stimulation (cTBS) will be applied over dorsolateral prefrontal cortex (DLPFC).
Other: Theta burst transcranial magnetic stimulation
Theta burst transcranial magnetic stimulation (cTBS) will be applied over the supramarginal gyrus (SMG).
Other: Theta burst transcranial magnetic stimulation
Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex.
Other: Sham theta burst transcranial magnetic stimulation
Continuous theta burst TMS (cTBS) will be delivered to a location on the head. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
Continuous theta burst TMS (cTBS) will be delivered near the head, while an unplugged TMS coil is held at the vertex. No current will be induced in the head with this procedure.
Motor Skill
Assessed by measuring movement accuracy on a maze-tracing task. Accuracy is defined by percent of movement path that falls within the maze. Participants traced the maze 10 times at 3 different speed ranges. Overall performance accuracy was taken as the mean accuracy across the three speed ranges. A change in mean accuracy reflects learning.
Time frame: Assessed 4 times during the 2-hour main session: Pre-cTBS ("Pre"), immediately post-cTBS ("Post1"), after 40 trials of maze-tracing practice ("Post2"), and after 80 trials of maze-tracing practice ("Post 3").
Proprioception
Two-alternative forced choice task where the robot moves the participant's hand in two different positions, and the participant reports whether second position was closer or further than first position. This data is fitted with a logistic regression relating the distance between the two positions and the likelihood that participant reports "further". The outcome measure is the distance at which the participant is equally likely to say "closer" or "further"; this is defined as the point of subjective equality, which indexes proprioceptive accuracy. If the number is small (close to zero), it means the person has high proprioceptive accuracy. If the number is large, it means the person is less accurate.
Time frame: Assessed at 2 timepoints during the 2-hour main session: pre-cTBS ("Pre") and post-cTBS ("Post").
Participants were recruited with flyers posted in the community. They were asked to complete an electronic screening form to determine basic eligibility and, if they appeared eligible, the experimenter scheduled the familiarization session.
| Milestone | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group |
|---|---|---|---|
| Started | 29 | 28 | 30 |
| Completed | 27 | 26 | 26 |
| Not completed | 2 | 2 | 4 |
| Withdrew: Withdrawal by subject | 2 | 2 | 4 |
Assessed by measuring movement accuracy on a maze-tracing task. Accuracy is defined by percent of movement path that falls within the maze. Participants traced the maze 10 times at 3 different speed ranges. Overall performance accuracy was taken as the mean accuracy across the three speed ranges. A change in mean accuracy reflects learning.
| Accuracy (%) | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group |
|---|---|---|---|
| Pre timepoint | 66.6 ± 9.3 | 59.4 ± 8.9 | 59.9 ± 10.6 |
| Post 1 timepoint | 64.9 ± 10.5 | 58.5 ± 9.7 | 63.5 ± 9.1 |
| Post 2 timepoint | 69.4 ± 8.6 | 61.8 ± 8.7 | 65.4 ± 10.9 |
| Post 3 timepoint | 68.2 ± 11.6 | 62.1 ± 10 | 66.3 ± 11.3 |
Two-alternative forced choice task where the robot moves the participant's hand in two different positions, and the participant reports whether second position was closer or further than first position. This data is fitted with a logistic regression relating the distance between the two positions and the likelihood that participant reports "further". The outcome measure is the distance at which the participant is equally likely to say "closer" or "further"; this is defined as the point of subjective equality, which indexes proprioceptive accuracy. If the number is small (close to zero), it means the person has high proprioceptive accuracy. If the number is large, it means the person is less accurate.
| mm | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group |
|---|---|---|---|
| Pre timepoint | 0.9 ± 0.62 | 0.79 ± 0.72 | 0.73 ± 0.56 |
| Post timepoint | 1.2 ± 1.14 | 0.8 ± 0.55 | 0.75 ± 0.79 |
Collected over Adverse events were monitored during each study visit: the familiarization session (about 1 hour), the MRI (about 30 minutes), and the main session (about 2 hours).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dorsolateral Prefrontal Cortex (DLPFC) | 0/28 (0%) | 0/28 (0%) | 5/28 (17.9%) |
| Supramarginal Gyrus (SMG) | 0/28 (0%) | 0/28 (0%) | 7/28 (25%) |
| Sham Control Group | 0/30 (0%) | 0/30 (0%) | 6/30 (20%) |
| Event | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group |
|---|---|---|---|
| Discomfort from TMSGeneral disorders | 4/28 | 7/28 | 5/30 |
| HeadacheNervous system disorders | 1/28 | 0/28 | 1/30 |
These are the participants who did the main session, where baseline measurements were made.
| Age, Continuous(years) | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group | Total |
|---|---|---|---|---|
| Mean | 25.2 ± 7.0 | 22.5 ± 3.6 | 23.1 ± 4.2 | 23.6 ± 5.3 |
| Sex: Female, Male(Participants) | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group | Total |
|---|---|---|---|---|
| Female | 14 | 16 | 12 | 42 |
| Male | 13 | 10 | 14 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 7 | 4 | 14 |
| Not Hispanic or Latino | 24 | 19 | 22 | 65 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 9 | 12 | 11 | 32 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 0 | 2 |
| White | 14 | 11 | 12 | 37 |
| More than one race | 3 | 2 | 3 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group | Total |
|---|---|---|---|---|
| United States | 27 | 26 | 26 | 79 |
| Edinburgh handedness inventory(units on a scale) | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group | Total |
|---|---|---|---|---|
| Mean | 89.2 ± 10.7 | 85.2 ± 16.5 | 78.4 ± 18.9 | 84.3 ± 16.1 |
| Resting Motor Threshold (RMT)(Percent of max stimulator output (%MSO)) | Dorsolateral Prefrontal Cortex (DLPFC) | Supramarginal Gyrus (SMG) | Sham Control Group | Total |
|---|---|---|---|---|
| Mean | 49.3 ± 9.7 | 50.7 ± 8.6 | 50.3 ± 8.0 | 50.1 ± 8.7 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Indiana University