Closed-loop rTMS-EEG During Visuomotor Integration.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
repetitive transcranial magnetic stimulation (rTMS)
DevicerTMS will be applied time-locked to the intrinsic brain rhythms to individually-defined brain regions
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: state-dependent repetitive transcranial magnetic stimulation (rTMS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
90 minutes2
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).
Time frame
90 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov