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Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes (VISUO-CEREBRO)

Primary Purpose

Stroke, Ischemic, Cerebellar Lesions

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional MRI sequences
Neuropsychological assessment
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke, Ischemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de BesançonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Additional MRI sequences

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
June 3, 2021
Last Updated
June 3, 2021
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT04920461
Brief Title
Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes
Acronym
VISUO-CEREBRO
Official Title
Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Cerebellar Lesions

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Additional MRI sequences
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Additional MRI sequences
Intervention Description
Additional MRI sequences (3D T2 SPACE sequence, 4/5 minutes approximatively)
Intervention Type
Other
Intervention Name(s)
Neuropsychological assessment
Intervention Description
Neurovisual function assessed with neuropsychological tests
Primary Outcome Measure Information:
Title
Presence of Neuro-Visual Disorder
Description
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)
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice VOILLY, MD
Phone
0033381668236
Email
avoilly@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eloi MAGNIN, MD, PhD
Organizational Affiliation
CHU de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VOILLY Alice, MD
Email
avoilly@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Eloi MAGNIN, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes

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