NCT05929144

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
May 2023Jul 2028

Study Start

First participant enrolled

May 5, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 3, 2023

Status Verified

May 1, 2023

Enrollment Period

5.2 years

First QC Date

May 25, 2023

Last Update Submit

June 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Optimization of MRI sequences

    TR, TE, Flip Angle, asset phase, asset slice parameters

    During MRI sessions

Study Arms (1)

Healthy volunteers

OTHER
Other: MRI sequences testing

Interventions

Testing different MRI sequences in order to optimize them

Healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers of legal age
  • Affiliation with a social security scheme or beneficiary of such a scheme
  • Signing of the protocol informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GIP Cyceron

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gaël Chételat, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR
  • Nicolas Cabé, MD, PhD

    CHU Caen Normandie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Géraldine Poisnel, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

July 3, 2023

Study Start

May 5, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations