Tapfinger Psychomotor Target (TAPFINGER)

May 17, 2022 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • CLINATEC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Pregancy
  • All categories of protected persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychomotor tasks
20 healthy subjects and 10 tetraplegic patients will participate to acquisition of MEG, EEG, MRI data during a motor tasks
Behavioral: Psychomotor tasks
the acquisition of data will be performed in one unique session no drug administration no surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MEG records for functional brain mapping
Time Frame: one hour study
This study is not a therapeutic clinical study. No treatment is being delivered.
one hour study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MEG measurements during psychomotor tasks
Time Frame: one hour study
MEG records induced by finger tapping will be performed either randomly or following sound bips pacing.
one hour study
EEG measurements during psychomotor tasks
Time Frame: one hour study
EEG records induced by finger tapping will be performed either randomly or following sound bips pacing.
one hour study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Commissariat A L'energie Atomique

Investigators

  • Principal Investigator: Alim L Benabid, MD, PhD, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-A00421-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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