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
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|
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|
|Estimated Enrollment :||135 participants|
|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|
- Electromyographic activity (EMG) [ Time Frame: One hour ]Participants' electromyographic activity will be recorded during an average of one hour.
- Electroencephalographic activity (EEG) [ Time Frame: One hour ]Participants' electroencephalographic activity will be recorded during an average of one hour.
- Oculometry : saccadic eye movement [ Time Frame: One hour ]Participants' saccadic eye movements will be recorded during an average of one hour.
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
|Contact: Sylvain Harquel, MS||+33607815939||sylvain.harquel@upmf-grenoble.Fr|
|UMS CNRS 3552 IRMaGe||Recruiting|
|Grenoble, RA, France, 38000|
|Contact: Sylvain Harquel, MS +33607815939 sylvain.harquel@upmf-grenoble.Fr|
|Principal Investigator: Thierry Bougerol, Dr|
|Principal Investigator:||Thierry BOUGEROL, PUPH||University Hospital, Grenoble|