Neural Basis of Sensory Learning: Brain Regions

NCT05079516 | Recruiting

• 2 other identifiers: 12517R01NS112367-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Basic Science

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (5)

• Visuo-proprioceptive weighting

  1 day

• Target hand reaching

  1 day.

• Target estimation variance

  1 day

• Motor cortex excitability (arms 1-3)

  1 day

• Tactile sensitivity (arms 1-3)

  1 day

Study Arms (7)

Primary motor cortex--Exp 1

EXPERIMENTAL

Theta burst transcranial magnetic stimulation (cTBS) will be applied over primary motor cortex.

Other: Theta burst transcranial magnetic stimulation

Somatosensory cortex--Exp 1

EXPERIMENTAL

Theta burst transcranial magnetic stimulation (cTBS) will be applied over primary somatosensory cortex.

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.

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.

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.

Other: Theta burst transcranial magnetic stimulation

Cerebellar cortex--Exp 2

EXPERIMENTAL

Theta burst transcranial magnetic stimulation (cTBS) will be applied over cerebellar cortex.

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.

Other: Theta burst transcranial magnetic stimulation

Interventions

Theta burst transcranial magnetic stimulation OTHER

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.

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Indiana University Bloomington

Bloomington, Indiana, 47405, United States

RECRUITING

Study Officials

• William P Hetrick, PhD

  Indiana University, Bloomington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William P Hetrick, PhD

CONTACT

8128552620; whetrick@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 15, 2021
• Study Start: October 26, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The data will become available when group results are published in peer-reviewed journals.
• Access Criteria: Data will be available on www.osf.io for anyone who wishes to download it. The relevant osf registry will be cited in the peer-reviewed publication so that interested readers can find it.

Locations

US (1)