NCT05739994

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 9, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 5, 2025

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

February 13, 2023

Results QC Date

November 15, 2025

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Assessed at 2 timepoints during the 2-hour main session: pre-cTBS ("Pre") and post-cTBS ("Post").

Study Arms (3)

Dorsolateral prefrontal cortex (DLPFC)

EXPERIMENTAL

Theta burst transcranial magnetic stimulation (cTBS) will be applied over dorsolateral prefrontal cortex (DLPFC).

Other: Theta burst transcranial magnetic stimulation

Supramarginal gyrus (SMG)

EXPERIMENTAL

Theta burst transcranial magnetic stimulation (cTBS) will be applied over the supramarginal gyrus (SMG).

Other: Theta burst transcranial magnetic stimulation

Sham control group

SHAM COMPARATOR

Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex.

Other: Sham theta burst transcranial magnetic stimulation

Interventions

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.

Dorsolateral prefrontal cortex (DLPFC)Supramarginal gyrus (SMG)

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.

Sham control group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Bloomington

Bloomington, Indiana, 47405, United States

Location

Limitations and Caveats

Fatigue is known to impair task performance and motor skill learning. Each participant took approximately 2 hours to complete the main session, which could have resulted in fatigue and poor attention during or by the end of it, even with breaks.

Results Point of Contact

Title
Dr. Hannah Block
Organization
Indiana University Bloomington

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 22, 2023

Study Start

June 9, 2023

Primary Completion

December 19, 2024

Study Completion

December 19, 2024

Last Updated

December 5, 2025

Results First Posted

December 5, 2025

Record last verified: 2025-11

Locations