Clincosm LogoSign in Get a demo

VISUO-CEREBRO: Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04920461
Collaborator
(none)
42
Enrollment
1
Location
1
Arm
14.5
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Additional MRI sequences
  • Other: Neuropsychological assessment
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes
Actual Study Start Date :
Apr 16, 2020
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Additional MRI sequences

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

Other: Neuropsychological assessment
Neurovisual function assessed with neuropsychological tests

Outcome Measures

Primary Outcome Measures

  1. Presence of Neuro-Visual Disorder [Month 3]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Signed informed consent form

  • Being able to pass initial neuropsychological tests within 10 days after stroke

Exclusion Criteria:

  • Previous central neural system/psychiatric/eye disease (including severe cranial trauma)

  • Chronic alcoholism

  • MRI contraindication.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Besançon Besançon France 25000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Eloi MAGNIN, MD, PhD, CHU de Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT04920461
Other Study ID Numbers:
  • P/2019/423
First Posted:
Jun 9, 2021
Last Update Posted:
Jun 9, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke
Ischemic Stroke
Perceptual Disorders

Study Results

No Results Posted as of Jun 9, 2021