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

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ClinicalTrials.gov Identifier: NCT02168413
Recruitment Status : Recruiting
First Posted : June 20, 2014
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Centre National de la Recherche Scientifique, France
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

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.


Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of New Cortical Excitability Methodologies Using Robotised and Neuronavigated Transcranial Magnetic Stimulation.
Actual Study Start Date : May 14, 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. Electromyographic activity (EMG) [ Time Frame: One hour ]
    Participants' electromyographic activity will be recorded during an average of one hour.


Secondary Outcome Measures :
  1. Electroencephalographic activity (EEG) [ Time Frame: One hour ]
    Participants' electroencephalographic activity will be recorded during an average of one hour.


Other Outcome Measures:
  1. Oculometry : saccadic eye movement [ Time Frame: One hour ]
    Participants' saccadic eye movements will be recorded during an average of one hour.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ealthy subjects
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168413


Contacts
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Contact: Sylvain Harquel, MS +33607815939 sylvain.harquel@upmf-grenoble.Fr

Locations
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France
UMS CNRS 3552 IRMaGe Recruiting
Grenoble, RA, France, 38000
Contact: Sylvain Harquel, MS    +33607815939    sylvain.harquel@upmf-grenoble.Fr   
Principal Investigator: Thierry Bougerol, Dr         
Sponsors and Collaborators
University Hospital, Grenoble
Centre National de la Recherche Scientifique, France
Investigators
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Principal Investigator: Thierry BOUGEROL, PUPH University Hospital, Grenoble
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02168413    
Other Study ID Numbers: 2013-A01734-41
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: October 2018
Keywords provided by University Hospital, Grenoble:
cortical excitability
robotized TMS
EEG
EMG