Cortical Excitability Using Robotised and Neuronavigated Transcranial Magnetic Stimulation (ROBEXCI)

Development of New Cortical Excitability Methodologies Using Robotised and Neuronavigated Transcranial Magnetic Stimulation.

This study has two main goals :

• to develop the cortcial excitbality (CE) measurement methodology using coupling between transcranial magnetic stimulation (TMS) and physiological recordings such as electroencephalography (EEG) and electromyography (EMG),
• to automatize these measurements using robotized TMS.

Assessing CE is a preliminary and crucial step in any TMS protocol, in either fundamental or clinical research. It is an important indicator which determine the stimulation power applied on the cortical target during the TMS experiment, or during the rTMS cure (patients). CE is in general measured on the motor cortex using EMG activity as the main indicator of the system's response, whatever the real cortical target is located. The present study thus propose to generalize this measurement on other cortical areas in link with the actual targets, and using other external recordings such as EEG. Moreover, as neuronavigation systems significantly improved TMS precision in the past years, CE measurements could significantly gain to become fully automatized using robotized TMS.

Study Overview

• Status: Completed
• Conditions: Cortical Excitability; Robotized TMS

Detailed Description

Eligibility Criteria :

CRITERIA OF INCLUSION

• Major Topic (18 to 75)
• Signed informed consent,
• A medical examination must be done before participation in research,
• Membership or beneficiary of a social security scheme,

CRITERIA OF NON-INCLUSION

• Topic of under 18 and over 75 years.
• Against-indications (CI) to the practice of MRI pacemaker or implantable defibrillator or pacemaker neurosensory (risk of temporary or permanent damage to the device or heating metal parts). Cochlear implants (risk of demagnetization, electrode temperature rise and artifacts). Ocular or cerebral ferromagnetic foreign body close to the nerve structures (risk of displacement and complications such as eye or brain damage). Metal prostheses (possibility of significant artifacts according to their size and their ferromagnetic character, some neurosurgical clips or heart valves can cause problems and require an investigation into the exact model implanted). Topics claustrophobic. Pregnant woman. Neurosurgical ventriculoperitoneal bypass valves. Irremovable metal braces.
• CI practice of TMS: the history of epilepsy or seizures during hyperthermia during childhood are related ICs. Ferrométalliques body presence in the brain, cochlear implants, pacemakers, insulin pumps, during pregnancy, about jet lag or not having slept the night before the session of TMS.
• Existence of a severe condition in general terms: cardiac, respiratory, hematologic, renal, hepatic, cancerous,
• Regular Taking anxiolytics, sedatives, antidepressants, neuroleptics,
• Psychiatric disorder characterized,
• Alcohol ingestion before the examination,
• Persons referred to in Articles L1121-5 to L1121-8 CSP.

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• France
  • RA
    • Grenoble, RA, France, 38000
      • UMS CNRS 3552 IRMaGe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ealthy subjects

Description

Inclusion Criteria:

• adult subjects (18 to 75 years old)
• consent form signed
• medical examination done prior to the experiment
• affiliated to the French social security

Exclusion Criteria:

• Exclusion criteria associated to MRI : pacemaker or neurosensory stimulator or implantable defibrillator. Cochlear implants. Ferromagnetic external bodies. Metal prosthesis. Claustrophobia. Pregnancy. Neurochirurgical bypass valves. Fixed metal dentures.
• Exclusion criteria associated to TMS : seizures antecedent. Pacemaker or neurosensory stimulator or implantable defibrillator. Cochlear implants. Ferromagnetic external bodies. Pregnancy. Insulin pump. Jet-lag or sleep deprivation. Severe medical affliction. Regular doses of anxiolytics, sedatives, antidepressant, neuroleptic. Psychiatric illness. Alcool ingestion prior to the experiment.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyographic activity (EMG)	Participants' electromyographic activity will be recorded during an average of one hour.	One hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalographic activity (EEG)	Participants' electroencephalographic activity will be recorded during an average of one hour.	One hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oculometry : saccadic eye movement	Participants' saccadic eye movements will be recorded during an average of one hour.	One hour

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Centre National de la Recherche Scientifique, France
• Investigators: Principal Investigator: Thierry BOUGEROL, PUPH, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2014
• Primary Completion (Actual): May 12, 2021
• Study Completion (Actual): May 12, 2021

Study Registration Dates

• First Submitted: May 23, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: EMG; EEG; cortical excitability; robotized TMS
• Other Study ID Numbers: 2013-A01734-41