NCT02168413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed
Last Updated

December 8, 2021

Status Verified

October 1, 2018

Enrollment Period

7 years

First QC Date

May 23, 2014

Last Update Submit

December 7, 2021

Conditions

Cortical ExcitabilityRobotized TMS

Keywords

cortical excitabilityrobotized TMSEEGEMG

Outcome Measures

Primary Outcomes (1)

  • Electromyographic activity (EMG)

    Participants' electromyographic activity will be recorded during an average of one hour.

    One hour

Secondary Outcomes (1)

  • Electroencephalographic activity (EEG)

    One hour

Other Outcomes (1)

  • Oculometry : saccadic eye movement

    One hour

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ealthy subjects

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMS CNRS 3552 IRMaGe

Grenoble, RA, 38000, France

Location

Study Officials

  • Thierry BOUGEROL, PUPH

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

June 20, 2014

Study Start

May 14, 2014

Primary Completion

May 12, 2021

Study Completion

May 12, 2021

Last Updated

December 8, 2021

Record last verified: 2018-10

Locations

FR(1)