Adjustment Exploratory Protocols and Functional Evaluatio... | NCT02790411

Studies
Adjustment Exploratory Protocols and Functional Evaluation of New Non Invasive Devices in Healthy Volunteers

NCT02790411

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Nov 14, 2022Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

Imaging devices
New Non Invasive Devices

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 21, 2013Actual

Primary Completion Date

May 21, 2021Actual

Completion Date

May 21, 2021Actual

First Submitted Date

May 12, 2016

First Submission Date that Met QC Criteria

May 30, 2016

First Posted Date

Jun 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2022

Last Update Posted Date

Nov 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy volunteers	Experimental	Imaging devices New Non Invasive Devices	Device: Imaging devices Device: New Non Invasive Devices

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imaging devices	Device	technological adjustment tests	healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Magnetic brain activity	MEG records	2 hours
Brain imaging	MRI and SPECT-CT records	2 hours
Electrical brain activity	EEG records	2 hours
Motor activity parameters	Motor platform records	2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CLINATEC		Grenoble		38000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided