Tapfinger Psychomotor Target

Functional Brain Mapping Clinical Trial

— TAPFINGER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574026
• Other study ID #: 2010-A00421-38
• Status: Completed
• Phase: Phase 1
• Start date: August 2010
• Est. completion date: July 31, 2020

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Functional Brain Mapping

Intervention

Behavioral:
• Psychomotor tasks
the acquisition of data will be performed in one unique session no drug administration no surgery

Locations

Country	Name	City	State
France	CLINATEC	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Commissariat A L'energie Atomique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MEG records for functional brain mapping	This study is not a therapeutic clinical study. No treatment is being delivered.	one hour study
Secondary	MEG measurements during psychomotor tasks	MEG records induced by finger tapping will be performed either randomly or following sound bips pacing.	one hour study
Secondary	EEG measurements during psychomotor tasks	EEG records induced by finger tapping will be performed either randomly or following sound bips pacing.	one hour study