Back to resultsOptimization of MRI Sequences Used in the Study of Neurodegenerative Diseases (IRMtests)
Primary Purpose
Memory Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI sequences testing
Sponsored by
About this trial
This is an interventional other trial for Memory Disorders
Eligibility Criteria
Inclusion Criteria: Healthy volunteers of legal age Affiliation with a social security scheme or beneficiary of such a scheme Signing of the protocol informed consent For women of childbearing age or capacity, a urine pregnancy test before inclusion Exclusion Criteria: Protected persons in accordance with articles L. 1121-5 to L.1121-8 of the Public Health Code: protected adults, pregnant and nursing women Presence of contraindications to MRI examination without contrast agents injection Presence of a chronic neurological or psychiatric condition (including substance use disorder) History of brain disease (vascular, degenerative, malformative, tumour, or head trauma with loss of consciousness for more than one hour) Current or recent use of medications that may interfere with imaging (psychotropic drugs, antihistamines with anticholinergic action, antiparkinsonian drugs, benzodiazepines including muscle relaxants, long-term steroidal anti-inflammatory drugs, antiepileptic drugs, central painkillers)
Sites / Locations
- GIP CyceronRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
Optimization of MRI sequences
TR, TE, Flip Angle, asset phase, asset slice parameters
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05929144
Brief Title
Optimization of MRI Sequences Used in the Study of Neurodegenerative Diseases
Acronym
IRMtests
Official Title
Optimization of MRI Sequences Used in the Study of Neurodegenerative Diseases at Inserm U1237 NeuroPresage Team, Cyceron Center in Caen
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
July 2028 (Anticipated)
Study Completion Date
July 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Inserm NeuroPresage team has been using MRI for more than 20 years in the study of normal ageing and memory pathologies to further the understanding and the characterization of early diagnosis and the cerebral substrates of cognitive deficits in patients, particularly in the context of neurodegenerative diseases.
Two years ago, a new 3T MRI camera was installed at the Cyceron centre. It is more efficient and should make it possible to obtain better quality images and/or to reduce the time required to acquire these images.
In this context, it seems important to test the different sequences that we classically use in our studies, or that we plan to implement in our next studies (learning and text retrieval fMRI task), in order to optimize them, with a view to integrating them in our future studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
MRI sequences testing
Intervention Description
Testing different MRI sequences in order to optimize them
Primary Outcome Measure Information:
Title
Optimization of MRI sequences
Description
TR, TE, Flip Angle, asset phase, asset slice parameters
Time Frame
During MRI sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers of legal age
Affiliation with a social security scheme or beneficiary of such a scheme
Signing of the protocol informed consent
For women of childbearing age or capacity, a urine pregnancy test before inclusion
Exclusion Criteria:
Protected persons in accordance with articles L. 1121-5 to L.1121-8 of the Public Health Code: protected adults, pregnant and nursing women
Presence of contraindications to MRI examination without contrast agents injection
Presence of a chronic neurological or psychiatric condition (including substance use disorder)
History of brain disease (vascular, degenerative, malformative, tumour, or head trauma with loss of consciousness for more than one hour)
Current or recent use of medications that may interfere with imaging (psychotropic drugs, antihistamines with anticholinergic action, antiparkinsonian drugs, benzodiazepines including muscle relaxants, long-term steroidal anti-inflammatory drugs, antiepileptic drugs, central painkillers)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Géraldine Poisnel, PhD
Phone
0231470206
Email
poisnel@cyceron.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaël Chételat, PhD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nicolas Cabé, MD, PhD
Organizational Affiliation
CHU Caen Normandie
Official's Role
Principal Investigator
Facility Information:
Facility Name
GIP Cyceron
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Géraldine Poisnel, PhD
Phone
0231470206
Email
poisnel@cyceron.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimization of MRI Sequences Used in the Study of Neurodegenerative Diseases
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