MAP-EFNI: Adjustment Exploratory Protocols and Functional Evaluation of New Non Invasive Devices in Healthy Volunteers

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02790411
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Duration (Months): 96
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Parameters, sequences or paradigms optimisation in view of data quality and relevancy improvement.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Device: Imaging devices; Device: New Non Invasive Devices	N/A

Detailed Description

Various tests are needed for methodological optimization of the several devices (per-operative MRI, MEG, EEG, SPECT-CT, motor platform) of the technological platform.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Adjustment Exploratory Protocols (MagnetoEncephaloGraphy Study : MEG, ElectroEncephaloGram : EEG, Magnetic Resonance Imaging : MRI, Functional MRI : MRIf, Motor Platform) and Functional Evaluation of New Non Invasive Devices (REX BIONICS Exoskeleton) in Healthy Volunteers
• Study Start Date: May 1, 2013
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: healthy volunteers Imaging devices New Non Invasive Devices	Device: Imaging devices; technological adjustment tests; Device: New Non Invasive Devices; Tests with REX BIONICS Exoskeleton

Outcome Measures

Primary Outcome Measures

1. Magnetic brain activity [2 hours]

   MEG records

2. Brain imaging [2 hours]

   MRI and SPECT-CT records

3. Electrical brain activity [2 hours]

   EEG records

4. Motor activity parameters [2 hours]

   Motor platform records

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteers

• Male or female aged over 18 years

• Registered in the French social security scheme

• Signed informed consent

Exclusion Criteria:

• Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)

• Contraindication to Magnetic resonance imaging (MRI)

• All categories of protected persons

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CLINATEC	Grenoble		France	38000

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT02790411
• Other Study ID Numbers: MAP-EFNI
• First Posted: Jun 3, 2016
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Mar 25, 2020