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NCT Number: NCT07249801

Closed-loop rTMS-EEG During Visuomotor Integration.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

About this study

There is a need for oscillatory or repetitive neuromodulatory tools and methods that are effective in entraining intrinsic neural rhythms to improve inefficient functional coupling within neural circuits. The goal of the proposed study is to develop a closed-loop application of repetitive transcranial magnetic stimulation (rTMS) and electroencephalography (EEG) suitable for use in multidomain precision neural-circuit based rehabilitation studies that permits the time-locked application of rTMS pulses to the phase of the intrinsic neural oscillation (personalized state-based application) in a defined behavioral context (e.g., goal-directed eye-hand control).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

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

Other names: non-invasive brain stimulation

Primary outcomes

  1. Change of whole hand grip force precision

    Time frame: 90 minutes

    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.

  2. Change of functional brain connectivity.

    Time frame: 90 minutes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kirstin-Friederike Heise, PhD

CONTACT

[email protected]

843-792-3435

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

State-dependent Entrainment of Intrinsic Brain Rhythms to Improve Interregional Functional Coupling.

Acronym: SYNC

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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