Closed-loop rTMS-EEG During Visuomotor Integration.

NCT07249801 | Recruiting DMC FDA Device

• 2 other identifiers: Pro001447821P50HD118628-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims at establishing personalized state-based rTMS for precision neurorehabilitation, we designed a within-subject cross-over study to test closed-loop repetitive transcranial magnetic stimulation and electroencephalography (rTMS-EEG) comparing the targeting of two key nodes in the frontoparietal network during bimanual visuomotor force tracking in persons with upper extremity sensorimotor impairment affecting eye-hand control.

Conditions

Visuomotor Skills; Brain Lesion (General)

Keywords

visuomotor processing; electroencephalography (EEG); transcranial magnetic stimulation (TMS); eye-hand control

Outcome Measures

Primary Outcomes (2)

• Change of whole hand grip force precision

  Force time series will be used to extract two measures for each trial to describe distinct features of visuomotor force adjustment: 1) Root Mean Square Error (RMSE) to characterize the deviation of the actual force from the target force, i.e., over- and undershoot and 2) sample entropy (SmpEn) to quantify the randomness or uncertainty of the sampled force time series. From these measures, the trial-based relative changes in RMSE and SmpEn from baseline (before intervention) will be computed.

  90 minutes

• Change of functional brain connectivity.

  Trial-specific phase-based connectivity will be extracted from the electroencephalography (EEG) time series and computed relative to baseline (before intervention).

  90 minutes

Study Arms (1)

state-dependent repetitive transcranial magnetic stimulation (rTMS)

EXPERIMENTAL

Repetitive TMS will be applied to cortical targets based on task-based (visuomotor) brain activation.

Device: repetitive transcranial magnetic stimulation (rTMS)

Interventions

repetitive transcranial magnetic stimulation (rTMS) DEVICE

rTMS will be applied time-locked to the intrinsic brain rhythms to individually-defined brain regions

Also known as: non-invasive brain stimulation

state-dependent repetitive transcranial magnetic stimulation (rTMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult volunteers (age ≥18 years)
• right-hand dominance (defined with the Edinburg Handedness Scale)
• voluntary whole-hand grip force (Medical Research Council scale for muscle force ≥2)
• capable of repeated grasp and release with 5% of maximum voluntary contraction (standardized with an in-house computer-based assessment involving whole-hand grip force tracking upon visual cues with a digital dynamometer).

You may not qualify if:

• presence of any MRI risk factors (such as an electrically, magnetically, mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips, any other electrically sensitive support system, or claustrophobia)
• presence of any contraindications to repetitive transcranial magnetic stimulation, rTMS (e.g., history of seizures or epileptic activity, currently taking medications that lower seizure thresholds)
• any neurological or psychiatric disorders affecting cognitive function (e.g., established dementia) affecting the ability to understand the purpose of the study and give informed consent or ability to complete cognitive testing
• substance use disorder
• visual impairment that precludes completion of scanner tasks
• uncontrolled hypertension despite treatment
• intake of tricyclic anti-depressants
• musculoskeletal disorders affecting bimanual grasp- and release
• pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). If the participant is a woman of childbearing potential, a urine pregnancy test will be performed on a standard basis.
• severe aphasia affecting particularly of receptive nature (NIH Stroke Scale, NIHSS Language subsection ≥2) affecting the ability to understand the purpose of the study and give informed consent
• pregnancy

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Kirstin-Friederike Heise, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirstin-Friederike Heise, PhD

CONTACT

843-792-3435; heisek@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After primary analyses, anticipated within 12-24 months after study completion.
• Access Criteria: Data will be shared through a secure repository. Requests may require a data use agreement and compliance with institutional and regulatory requirements.

Locations

US (1)