Basic ScienceNCT05079516
Neural Basis of Sensory Learning: Brain Regions
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 sensory and motor areas of the brain work together to keep a person's hand movements accurate (sensorimotor learning). The investigators hope this information may be useful one day to improve rehabilitation techniques in patients with brain lesions. 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
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2021to Dec 2026
- 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 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. Aging has been shown to affect the morphology of sensory and motor nerves, conduction velocities of nerves, and number of motor neurons in the spinal cord; to avoid these confounding factors we will only examine younger-to middle-aged adults.
- There are differences in cortical function and corticospinal projections such that testing the right arm of a right-handed individual is not necessarily equivalent to testing the left arm of a left-handed individual. To eliminate this confound, we will only test right-handed individuals. All these factors will be determined with the initial screening questions.
- Covid has been found to have neurological effects in some people, but mostly the effects on sensorimotor control and neurophysiology are unknown. So we want to reduce the chances of inadvertently testing subjects who have covid. We will therefore only include individuals who are fully vaccinated (2+ weeks past their final vaccine dose) or have a negative Covid test within 4 days of testing. We will further only include individuals who report being free of Covid symptoms in week preceding testing.
Who cannot join
- Determined with initial screening questions, pre-enrollment:
- Potential subjects will be excluded for 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.
- 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.
- Determined on each day of TMS testing:
- 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 and if they haven't been fully vaccinated or obtained a negative Covid test within the past 4 days. If they don't believe they can meet these criteria on another date, they will be excluded.
- Determined during the Familiarization session.
- After giving their consent, participants may be excluded during or after the familiarization session if they are unable to perform the reaching task 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Bloomington
Bloomington, Indiana, 47405
Study Coordinator, 8128554079, blocklab@indiana.edu
About this study
The purpose of this study is to understand how the sensory and motor areas of the brain work together to keep a person's hand movements accurate (sensorimotor learning). The investigators hope this information may be useful one day to improve rehabilitation techniques in patients with brain lesions.
Read the detailed description
To make accurate movements, the brain needs to compensate for the frequent changes in the environment one experiences (lighting conditions, slippery floors, etc). For example, when one reaches to grab an object underwater, there are significant challenges the brain must overcome. Water is more viscous than air, so motor planning must take the increased resistance into account. In addition, light is bent by water, so one sees the underwater hand in a different location from where one feels it with body position sense (proprioception, from sensors in the joints and muscles). While initially movement errors occur in a situation like this, a healthy person quickly learns to compensate. This compensation can take different forms. The brain can shift the proprioceptive estimate closer to the visual estimate of hand position or vice versa (sensory realignment), or the brain can compensate for any movement errors by altering the motor commands to the arm (motor adaptation).
Failure to compensate for such changes 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, the investigators 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 a reaching task known to involve sensory realignment (learning). If performance of the task is affected by cTBS for a given group (relative to the sham, or control, group), it means that brain region plays some role in that type of reaching task.
- Conditions
- Basic Science
- Being tested
- 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
Real or sham continuous theta burst TMS (cTBS) will be delivered to a location on the head, determined by randomized group assignment. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Primary motor cortex--Exp 1 | Experimental | Theta burst transcranial magnetic stimulation (cTBS) will be applied over primary motor cortex. Receives: Other: Theta burst transcranial magnetic stimulation |
| Somatosensory cortex--Exp 1 | Experimental | Theta burst transcranial magnetic stimulation (cTBS) will be applied over primary somatosensory cortex. Receives: Other: Theta burst transcranial magnetic stimulation |
| Vertex sham--Exp 1 | Sham comparator | Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex. Receives: Other: Theta burst transcranial magnetic stimulation |
| Anterior superior parietal lobule--Exp 2 | Experimental | Theta burst transcranial magnetic stimulation (cTBS) will be applied over Anterior superior parietal lobule. Receives: Other: Theta burst transcranial magnetic stimulation |
| Ventral premotor cortex--Exp 2 | Experimental | Theta burst transcranial magnetic stimulation (cTBS) will be applied over Ventral premotor cortex. Receives: Other: Theta burst transcranial magnetic stimulation |
| Cerebellar cortex--Exp 2 | Experimental | Theta burst transcranial magnetic stimulation (cTBS) will be applied over cerebellar cortex. Receives: Other: Theta burst transcranial magnetic stimulation |
| Vertex sham--Exp 2 | Sham comparator | Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex. Receives: Other: Theta burst transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Realignment
Measured by comparing where the subject points on a touchscreen when indicating perceived position of visual and proprioceptive targets early vs. late in the behavioral task.
Measured: 1 day
Secondary outcomes (5)
Visuo-proprioceptive weighting
The degree to which participant relies on vision vs. proprioception when both are available. Measured by comparing where the subject points on a touchscreen when indicating perceived position of visual vs. proprioceptive targets.
Measured: 1 day
Target hand reaching
Location participant points at with no performance feedback.
Measured: 1 day.
Target estimation variance
Variance with which participant estimate visual and proprioceptive target positions. Computed from where subjects point at targets on a touchscreen.
Measured: 1 day
Motor cortex excitability (arms 1-3)
mean motor evoked potential amplitude at SI1mV (stimulus intensity that elicits 1 mV response). Measured pre- and post-cTBS in Arms 1-3 only.
Measured: 1 day
Tactile sensitivity (arms 1-3)
Two-point discrimination threshold on the target index fingertip. Measured pre- and post-cTBS in Arms 1-3 only.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start26 Oct 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- The study includes two experiments. Experiment 1 includes Arms 1-3, and Experiment 2 includes Arms 4-7. Arm assignment will be random within each experiment.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bill Hetrick, Indiana University
- Investigators
- William P Hetrick, PhD, Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079516
- Sponsor's protocol ID
- 12517
- Other IDs
- R01NS112367-01A1
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results published in peer-reviewed journals will be shared. Only de-identified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Basis of Sensory Learning: Brain Regions
- ClinicalTrials.gov ID
- NCT05079516
- Acronym / sponsor ID
- 12517
- Conditions
- Basic Science
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
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 sensory and motor areas of the brain work together to keep a person's hand movements accurate (sensorimotor learning). The investigators hope this information may be useful one day to improve rehabilitation techniques in patients with brain lesions.
Detailed description
To make accurate movements, the brain needs to compensate for the frequent changes in the environment one experiences (lighting conditions, slippery floors, etc). For example, when one reaches to grab an object underwater, there are significant challenges the brain must overcome. Water is more viscous than air, so motor planning must take the increased resistance into account. In addition, light is bent by water, so one sees the underwater hand in a different location from where one feels it with body position sense (proprioception, from sensors in the joints and muscles). While initially movement errors occur in a situation like this, a healthy person quickly learns to compensate. This compensation can take different forms. The brain can shift the proprioceptive estimate closer to the visual estimate of hand position or vice versa (sensory realignment), or the brain can compensate for any movement errors by altering the motor commands to the arm (motor adaptation).
Failure to compensate for such changes 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, the investigators 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 a reaching task known to involve sensory realignment (learning). If performance of the task is affected by cTBS for a given group (relative to the sham, or control, group), it means that brain region plays some role in that type of reaching task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- The study includes two experiments. Experiment 1 includes Arms 1-3, and Experiment 2 includes Arms 4-7. Arm assignment will be random within each experiment.
| Arm | Type | Receives |
|---|---|---|
| Primary motor cortex--Exp 1 | Experimental | Other: Theta burst transcranial magnetic stimulationTheta burst transcranial magnetic stimulation (cTBS) will be applied over primary motor cortex. |
| Somatosensory cortex--Exp 1 | Experimental | Other: Theta burst transcranial magnetic stimulationTheta burst transcranial magnetic stimulation (cTBS) will be applied over primary somatosensory cortex. |
| Vertex sham--Exp 1 | Sham comparator | Other: Theta burst transcranial magnetic stimulationSham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex. |
| Anterior superior parietal lobule--Exp 2 | Experimental | Other: Theta burst transcranial magnetic stimulationTheta burst transcranial magnetic stimulation (cTBS) will be applied over Anterior superior parietal lobule. |
| Ventral premotor cortex--Exp 2 | Experimental | Other: Theta burst transcranial magnetic stimulationTheta burst transcranial magnetic stimulation (cTBS) will be applied over Ventral premotor cortex. |
| Cerebellar cortex--Exp 2 | Experimental | Other: Theta burst transcranial magnetic stimulationTheta burst transcranial magnetic stimulation (cTBS) will be applied over cerebellar cortex. |
| Vertex sham--Exp 2 | Sham comparator | Other: 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. Aging has been shown to affect the morphology of sensory and motor nerves, conduction velocities of nerves, and number of motor neurons in the spinal cord; to avoid these confounding factors we will only examine younger-to middle-aged adults.
- There are differences in cortical function and corticospinal projections such that testing the right arm of a right-handed individual is not necessarily equivalent to testing the left arm of a left-handed individual. To eliminate this confound, we will only test right-handed individuals. All these factors will be determined with the initial screening questions.
- Covid has been found to have neurological effects in some people, but mostly the effects on sensorimotor control and neurophysiology are unknown. So we want to reduce the chances of inadvertently testing subjects who have covid. We will therefore only include individuals who are fully vaccinated (2+ weeks past their final vaccine dose) or have a negative Covid test within 4 days of testing. We will further only include individuals who report being free of Covid symptoms in week preceding testing.
Key exclusion criteria (7 listed)
- Determined with initial screening questions, pre-enrollment:
- Potential subjects will be excluded for 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.
- 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.
- Determined on each day of TMS testing:
- 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 and if they haven't been fully vaccinated or obtained a negative Covid test within the past 4 days. If they don't believe they can meet these criteria on another date, they will be excluded.
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 stimulationReal or sham continuous theta burst TMS (cTBS) will be delivered to a location on the head, determined by randomized group assignment. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz. | Other | Anterior superior parietal lobule--Exp 2, Cerebellar cortex--Exp 2, Primary motor cortex--Exp 1, Somatosensory cortex--Exp 1, Ventral premotor cortex--Exp 2, Vertex sham--Exp 1, Vertex sham--Exp 2 |
Primary outcome
Realignment
Time frame: 1 day
Measured by comparing where the subject points on a touchscreen when indicating perceived position of visual and proprioceptive targets early vs. late in the behavioral task.
5 secondary outcomes
Visuo-proprioceptive weighting
Time frame: 1 day
Target hand reaching
Time frame: 1 day.
Target estimation variance
Time frame: 1 day
Motor cortex excitability (arms 1-3)
Time frame: 1 day
Tactile sensitivity (arms 1-3)
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results published in peer-reviewed journals will be shared. Only de-identified data will be shared.
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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.
William P Hetrick, PhD principal investigator
Indiana University, Bloomington
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 7 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: looking for participants now, as of the sponsor's last update on 4 May 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 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?
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?
Contact William P Hetrick, PhD (8128552620, whetrick@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Realignment (time frame: 1 day). 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 4 May 2026.