NCT04145414

Brief Summary

Assess the reproductibility of PC-MRI for cerebrospinal fluid movements through the interventricular foramina on volunteer subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 13, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

December 7, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

October 29, 2019

Last Update Submit

November 23, 2021

Conditions

CSF Circulation DisorderForamen; Monro, ObstructionMri

Keywords

CSFPC-MRIinterventricular foramina

Outcome Measures

Primary Outcomes (1)

  • PC-MRI procedure reproductibility

    Test-retest reproducibility of double measures (2nd measure at +48 hours minimum +6 weeks maximum) of 4 cerebrospinal liquid (CSL) flow parameters during PC-MRI. CSL flow through interventricular foramina will be measured within healthy volunteers, and 4 intraclass correlation coefficients (ICC) will be calculated. The test-retest coefficient will be considered satisfactory if \> or = to 0.75 .

    week 6

Study Arms (1)

Cerebral magnetic resonance imaging x2

EXPERIMENTAL

Cerebral MRI performed at enrolment visit and at +6 weeks (maximum)

Device: MRI

Interventions

MRIDEVICE

Reproductibility test assessed with MRI for cerebrospinal fluid movements

Cerebral magnetic resonance imaging x2

Eligibility Criteria

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

You may qualify if:

  • Mini-Mental State Examination score \> 28/30

You may not qualify if:

  • MRI contraindication
  • Medical or surgical history related to following pathologies: nervous system disease, cardiac arrhythmia, cardiac or respiratory insufficiency.
  • Long-term medical treatment
  • Ongoing pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Laurent TATU, MD, PhD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

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

October 29, 2019

First Posted

October 30, 2019

Study Start

June 13, 2019

Primary Completion

January 14, 2020

Study Completion

January 14, 2020

Last Updated

December 7, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)