Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 23, 2014
First Posted Date June 20, 2014
Last Update Posted Date January 7, 2019
Actual Study Start Date May 14, 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2014)
Electromyographic activity (EMG) [ Time Frame: One hour ]
Participants' electromyographic activity will be recorded during an average of one hour.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 19, 2014)
Electroencephalographic activity (EEG) [ Time Frame: One hour ]
Participants' electroencephalographic activity will be recorded during an average of one hour.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 19, 2014)
Oculometry : saccadic eye movement [ Time Frame: One hour ]
Participants' saccadic eye movements will be recorded during an average of one hour.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Cortical Excitability Using Robotised and Neuronavigated Transcranial Magnetic Stimulation
Official Title Development of New Cortical Excitability Methodologies Using Robotised and Neuronavigated Transcranial Magnetic Stimulation.
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Ealthy subjects
Condition
  • Cortical Excitability
  • Robotized TMS
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 19, 2017)
135
Original Estimated Enrollment
 (submitted: June 19, 2014)
75
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sylvain Harquel, MS +33607815939 sylvain.harquel@upmf-grenoble.Fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02168413
Other Study ID Numbers 2013-A01734-41
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor University Hospital, Grenoble
Collaborators Centre National de la Recherche Scientifique, France
Investigators
Principal Investigator: Thierry BOUGEROL, PUPH University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date October 2018