Basic ScienceNCT05739994
Frontal and Parietal Contributions to Proprioception and Motor Skill Learning
A study testing Theta burst transcranial magnetic stimulation in people with Basic Science, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Science
- What is being tested?
- Theta burst transcranial magnetic stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2023to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Potential subjects must be between the ages of 18-45 years old and right-handed.
- We will only test right-handed individuals.
- We will only include individuals who report being free of Covid symptoms in week preceding testing.
Who cannot join
- Current vision problems, other than needing glasses or contacts.
- Subjects will also be excluded if they currently suffer from frequent severe headaches, glaucoma, heart or respiratory disease, hypertension, psychiatric conditions, or learning or attention conditions.
- They will also be excluded for current or past: visual, hearing, or balance impairments; stroke, seizure/epilepsy (including family history), or severe head trauma; fainting; or diabetes.
- Subjects will be excluded for metal implants in the head other than titanium; cochlear implants; implanted neurostimulator; cardiac pacemaker; intracardiac lines; or a medication infusion device.
- Because TMS does not penetrate deeply into the head, we cannot test subjects whose hair does not permit contact between the TMS coil and the scalp. We will therefore exclude subjects with dreadlocks, weaves, or hair extensions.
- To protect the data from extraneous peripheral influences, we will also exclude subjects who have had serious injury to the bones, joints, or muscles of either hand or arm, and have not fully recovered. For the purpose of this study, "fully recovered" means they no longer notice any pain, weakness, or loss of sensation in the injured area, and have no mobility limitations.
Show all 12Show fewer
- For the validity of our data, we will exclude subjects taking medications or drugs that are known to affect cortical excitability and possibly seizure risk in an rTMS study. These medications/drugs are (Rossi et al., 2009): imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel's dust), ketamine, gamma-hydroxybutyrate (GHB), theophylline, mianserin, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, reboxetine, venlafaxine, duloxetine, bupropion, mirtazapine, fluphenazine, pimozide, haloperidol, olanzapine, quetiapine, aripiprazole, ziprasidone, risperidone, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, BCNU, lithium, anticholinergics, antihistamines, sympathomimetics.
- Participants will also be excluded if they have metallic, mechanical, or magnetic implants; are claustrophobic, or are unable to remain still for long periods of time; or use an intra-uterine device (IUD) whos MR compatibility has not been established.
- Women who are pregnant or think they might be pregnant will also be excluded, as effects of fMRI on the unborn are not known.
- People who have a BMI over 30 will be excluded as it may be uncomfortable or impossible to lay in the MRI scanner.
- Potential subjects will be invited to reschedule if they would otherwise be eligible (according to the initial screening), but the day of testing have drunk more than 3 units of alcohol or taken other recreational drugs in the 24 hour period prior to testing; have had more than 3 cups of coffee in the last hour; are sleep deprived (<4 hours sleep the previous night); or have participated in another brain stimulation experiment the same day. These are standard in the TMS literature to protect the validity of the data and keep seizure risk minimal. In addition, we will invite invite subjects to reschedule if they have any of the common Covid symptoms within the last week. If they don't believe they can meet these criteria on another date, they will be excluded.
- After giving their consent, participants may be excluded during or after the familiarization session if they are unable to perform the tasks or follow instructions, or if their TMS stimulation parameters cannot be reliably determined by the experimenter, or if TMS is not well tolerated.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Bloomington
Bloomington, Indiana, 47405
About this study
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.
Read the detailed description
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.
- Conditions
- Basic Science
- Being tested
- Theta burst transcranial magnetic stimulation, Sham theta burst transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta burst transcranial magnetic stimulationOther
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.
Sham theta burst transcranial magnetic stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dorsolateral prefrontal cortex (DLPFC) | Experimental | Theta burst transcranial magnetic stimulation (cTBS) will be applied over dorsolateral prefrontal cortex (DLPFC). Receives: Other: Theta burst transcranial magnetic stimulation |
| Supramarginal gyrus (SMG) | Experimental | Theta burst transcranial magnetic stimulation (cTBS) will be applied over the supramarginal gyrus (SMG). Receives: Other: Theta burst transcranial magnetic stimulation |
| Sham control group | Sham comparator | Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex. Receives: Other: Sham theta burst transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed at 2 timepoints during the 2-hour main session: pre-cTBS ("Pre") and post-cTBS ("Post").
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start9 Jun 2023
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Basic ScienceStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Justine Block, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739994
- Sponsor's protocol ID
- 17096
- Other IDs
- R01NS112367-01A1
- Status last verified
- Nov 2025
- First submitted
- 13 Feb 2023
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontal and Parietal Contributions to Proprioception and Motor Skill Learning
- ClinicalTrials.gov ID
- NCT05739994
- Acronym / sponsor ID
- 17096
- Conditions
- Basic Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Posted 5 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dorsolateral prefrontal cortex (DLPFC) | Experimental | Other: Theta burst transcranial magnetic stimulationTheta burst transcranial magnetic stimulation (cTBS) will be applied over dorsolateral prefrontal cortex (DLPFC). |
| Supramarginal gyrus (SMG) | Experimental | Other: Theta burst transcranial magnetic stimulationTheta burst transcranial magnetic stimulation (cTBS) will be applied over the supramarginal gyrus (SMG). |
| Sham control group | Sham comparator | Other: Sham theta burst transcranial magnetic stimulationSham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Potential subjects must be between the ages of 18-45 years old and right-handed.
- We will only test right-handed individuals.
- We will only include individuals who report being free of Covid symptoms in week preceding testing.
Key exclusion criteria (12 listed)
- Current vision problems, other than needing glasses or contacts.
- Subjects will also be excluded if they currently suffer from frequent severe headaches, glaucoma, heart or respiratory disease, hypertension, psychiatric conditions, or learning or attention conditions.
- They will also be excluded for current or past: visual, hearing, or balance impairments; stroke, seizure/epilepsy (including family history), or severe head trauma; fainting; or diabetes.
- Subjects will be excluded for metal implants in the head other than titanium; cochlear implants; implanted neurostimulator; cardiac pacemaker; intracardiac lines; or a medication infusion device.
- Because TMS does not penetrate deeply into the head, we cannot test subjects whose hair does not permit contact between the TMS coil and the scalp. We will therefore exclude subjects with dreadlocks, weaves, or hair extensions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theta burst transcranial magnetic stimulationContinuous 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. | Other | Dorsolateral prefrontal cortex (DLPFC), Supramarginal gyrus (SMG) |
| Sham theta burst transcranial magnetic stimulationContinuous 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. | Other | Sham control group |
Primary outcome
Motor Skill
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").
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.
Proprioception
Time frame: Assessed at 2 timepoints during the 2-hour main session: pre-cTBS ("Pre") and post-cTBS ("Post").
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta burst transcranial magnetic stimulation in people with Basic Science, run by Indiana University at 1 site in United States.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 5 Dec 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Motor Skill (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").). The study lists 2 primary outcomes in all. 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 5 Dec 2025.