NCT04920461

Brief Summary

This study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

April 16, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

June 3, 2021

Last Update Submit

June 3, 2021

Conditions

Stroke, IschemicCerebellar Lesions

Outcome Measures

Primary Outcomes (1)

  • Presence of Neuro-Visual Disorder

    Presence of neuro-visual disorder will be confirmed by obtaining at least 2 pathological scores at following neuropsychological tests: * Rey \& Taylor figures (score from 0 to 36, maximum) * Judgment of Line Orientation (score from 0 to 36, maximum) * Weschler Adult Intelligence Scale (final score is intelligence quotient, with an average score is fixed at 100) * Test of Attentional Performance * Visual Object and Space Perception Battery (eight tests each designed to assess a particular aspect of object or space perception, while minimising the involvement of other cognitive skills) * Visual agnosia assesment protocole (noted on 10 points)

    Month 3

Study Arms (1)

Additional MRI sequences

EXPERIMENTAL
Device: Additional MRI sequencesOther: Neuropsychological assessment

Interventions

Additional MRI sequencesDEVICE

Additional MRI sequences (3D T2 SPACE sequence, 4/5 minutes approximatively)

Additional MRI sequences
Neuropsychological assessmentOTHER

Neurovisual function assessed with neuropsychological tests

Additional MRI sequences

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent form
  • Being able to pass initial neuropsychological tests within 10 days after stroke

You may not qualify if:

  • Previous central neural system/psychiatric/eye disease (including severe cranial trauma)
  • Chronic alcoholism
  • MRI contraindication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Eloi MAGNIN, MD, PhD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice VOILLY, MD

CONTACT

0033381668236avoilly@chu-besancon.fr

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

June 3, 2021

First Posted

June 9, 2021

Study Start

April 16, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

June 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)