Menu
Recruiting NCT07249801

Closed-loop rTMS-EEG During Visuomotor Integration.

No phase Interventional Visuomotor Skills Brain Lesion (General)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: repetitive transcranial magnetic stimulation (rTMS).
Who it may be relevant to
Registry conditions: Visuomotor Skills, Brain Lesion (General). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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).

Interventions

  • Device repetitive transcranial magnetic stimulation (rTMS)
    rTMS will be applied time-locked to the intrinsic brain rhythms to individually-defined brain regions

Primary outcome measures

  • Change of whole hand grip force precision [Time frame: 90 minutes]
  • Change of functional brain connectivity. [Time frame: 90 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT07249801 · Pro00144782 · 1P50HD118628-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗