- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160235
Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Voluntary Patients (MAP-PV)
October 19, 2021 updated by: University Hospital, Grenoble
Studies that will be carried out on healthy volunteers will have as main objective the development and optimization of the parameters of sequences or the design of the paradigms of stimulation in order to optimize the quality and the relevance of the images realized taking in Taking account of anatomical, functional or metabolic parameters, or integrating new approaches resulting from technical evolutions
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The pathologies that interest us in these refinements concern mainly the chronic (or sequellar) brain disorders which can be degenerative, developmental or vascular.
The patients who will be recruited will be known patients of our Service (University Clinic of Neuroradiology and MRI) that we follow during checks.
The type of examination that will be applied to them, between MRI, EEG and NIRS, will be specified in the consent form.
These examinations will not be invoiced either to the patient or to the social security, and the related costs will be borne by our Federative Research Structure or sometimes, when these explorations are upstream of a defined research protocol and funded, They will be financed under this protocol.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
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
-
-
-
Grenoble, France, 38043
- CHU Grenoble-Alpes
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- major voluntary patients
- socially insured.
- Karnofsky score above 60%.
- given their consent.
- absence of contraindication to the MRI examination
Exclusion Criteria:
- Subjects under the age of 18
- pregnant women
- persons referred to in articles L1121-5 to L1121-8 of the CSP.
- Patients with acute illness
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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Development of MRI protocols
MRI exam to grade differents interventions for future research
|
|
Experimental: Development of EEG protocols
EEF exam to grade differents interventions for future research
|
|
Experimental: Development of NIRS protocols
NIRS exam to grade differents interventions for future research
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Spatial resolution of new MRI imaging sequences MRI scanning.
Time Frame: Two hours
|
Two hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
February 1, 2013
Primary Completion (Actual)
July 8, 2021
Study Completion (Actual)
July 8, 2021
Study Registration Dates
First Submitted
April 24, 2017
First Submitted That Met QC Criteria
May 17, 2017
First Posted (Actual)
May 19, 2017
Study Record Updates
Last Update Posted (Actual)
October 20, 2021
Last Update Submitted That Met QC Criteria
October 19, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 38RC12.239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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