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Clinical Trials/NCT02574026
NCT02574026
Completed
Phase 1

MagnetoEncephaloGraphy Study of Cerebral Activations Induced by Psychomotor Tasks for Target Localisation in View of BCI Clinical Trial

University Hospital, Grenoble1 site in 1 country37 target enrollmentAugust 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Functional Brain Mapping
Sponsor
University Hospital, Grenoble
Enrollment
37
Locations
1
Primary Endpoint
MEG records for functional brain mapping
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal volunteers by tapping the finger .

Detailed Description

Normal healthy (20) volunteers and tetraplegic patients(10) will be submitted to the temporo-spatial mapping of their brain activity, both sensory and motor, induced by a simple behavioral task, consisting on tapping with the finger on a detection pad. This will be done in a light and then dark environment, on a rythm spontaneous and then paced by sound bips. Accelerometric recording will provide the three dimensionnal displacements of the finger as well as the time code. Brain activity is simultaneously recorded using MEG (306 channels) and EEG (64 channels. Data will be processed by an INPLS algorithm to detect the predictors of activity, their location and time-course. 3D mapping data will be matched with the patient's anatomy provided by 1.5T MRI previously performed. The aim of the study is to prepare the strategy of implantation of multielectrodes ECoG implants to restore motility in tetraplegic patients in a human BCI protocol currently under development.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
July 31, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or Female between 18 and 70 years
  • Informed consent
  • Benefiting from Social Security
  • French or english speaking, to understand study procedure
  • Tetraplegic patients : traumatic injury of the cervical spine with retained respiratory autonomy and without associated head injury

Exclusion Criteria

  • Contra-indication to MRI
  • Claustrophobia
  • Mental disorders
  • All categories of protected persons

Outcomes

Primary Outcomes

MEG records for functional brain mapping

Time Frame: one hour study

This study is not a therapeutic clinical study. No treatment is being delivered.

Secondary Outcomes

  • MEG measurements during psychomotor tasks(one hour study)
  • EEG measurements during psychomotor tasks(one hour study)

Study Sites (1)

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