Back to resultsVestibular Disorder and Visuo-spatial Functions
Primary Purpose
Vestibular Diseases, Vertigo
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cognitive and neuropsychological assesment
Sponsored by
About this trial
This is an interventional diagnostic trial for Vestibular Diseases
Eligibility Criteria
For participants of the questionnaire study :
Participants with vertigo complaints versus participants without vertigo complaints.
For patients of the behavioural study :
Inclusion Criteria:
- Vestibular disorder (with or without vertigo)
- Deafness / hard of hearing
Exclusion Criteria:
- Neurological or psychiatric conditions
- Cochlear Implant (for functional magnetic resonance imaging study)
Sites / Locations
- Cliniques universitaires Saint-Luc-UCL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Patient group
Control group
Arm Description
This group will consist of vestibular patients and/or participants with vertigo.
This group will consist of participants without vestibular/vertigo impairments.
Outcomes
Primary Outcome Measures
Vestibular questionnaire (Newly developed to evaluate cognitive abilities)
Participants will be recruited and tested within one week of recruitment. Testing will be online and will take around 20 minutes on average. The new questionnaire will evaluate demographic questions, and different cognition abilities using a likert-scale.
Standard computerized cognitive assessment (For example : Test of attentional performance, digit span, visuo-spatial span, line bisection task,...)
Participants will be recruited and tested within one week of recruitment. Testing will be at the hospital and will take 2 hours maximum. Standard computerized cognitive assessment will be used such as the Test of attentional performance (TAP2.2), digit span, visuo-spatial span, line bisection task, etc. Reaction times, errors and omissions will be recorded.
Secondary Outcome Measures
Full Information
NCT ID
NCT02533739
First Posted
August 12, 2015
Last Updated
April 8, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT02533739
Brief Title
Vestibular Disorder and Visuo-spatial Functions
Official Title
Impact Des déficits Vestibulaires Sur le développement Des Fonctions Visuo-spatiales.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
5. Study Description
Brief Summary
The purpose of these studies is to determine whether vestibular disorders could affect visuo-spatial cognition. Visuo-spatial cognition will be evaluated using a new questionnaire and a new computerized test using a digital tablet in different studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Diseases, Vertigo
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient group
Arm Type
Experimental
Arm Description
This group will consist of vestibular patients and/or participants with vertigo.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
This group will consist of participants without vestibular/vertigo impairments.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive and neuropsychological assesment
Primary Outcome Measure Information:
Title
Vestibular questionnaire (Newly developed to evaluate cognitive abilities)
Description
Participants will be recruited and tested within one week of recruitment. Testing will be online and will take around 20 minutes on average. The new questionnaire will evaluate demographic questions, and different cognition abilities using a likert-scale.
Time Frame
Within one week after recruitment
Title
Standard computerized cognitive assessment (For example : Test of attentional performance, digit span, visuo-spatial span, line bisection task,...)
Description
Participants will be recruited and tested within one week of recruitment. Testing will be at the hospital and will take 2 hours maximum. Standard computerized cognitive assessment will be used such as the Test of attentional performance (TAP2.2), digit span, visuo-spatial span, line bisection task, etc. Reaction times, errors and omissions will be recorded.
Time Frame
Within one week after recruitment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For participants of the questionnaire study :
Participants with vertigo complaints versus participants without vertigo complaints.
For patients of the behavioural study :
Inclusion Criteria:
Vestibular disorder (with or without vertigo)
Deafness / hard of hearing
Exclusion Criteria:
Neurological or psychiatric conditions
Cochlear Implant (for functional magnetic resonance imaging study)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naïma Deggouj
Organizational Affiliation
Cliniques universitaires Saint-Luc-UCL
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc-UCL
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Vestibular Disorder and Visuo-spatial Functions
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