Vestibular Disorder and Visuo-spatial Functions

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT02533739
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibular Diseases; Vertigo	Behavioral: Cognitive and neuropsychological assesment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Impact Des déficits Vestibulaires Sur le développement Des Fonctions Visuo-spatiales.
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient group This group will consist of vestibular patients and/or participants with vertigo.	Behavioral: Cognitive and neuropsychological assesment
Sham Comparator: Control group This group will consist of participants without vestibular/vertigo impairments.	Behavioral: Cognitive and neuropsychological assesment

Outcome Measures

Primary Outcome Measures

1. Vestibular questionnaire (Newly developed to evaluate cognitive abilities) [Within one week after recruitment]

   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.

2. Standard computerized cognitive assessment (For example : Test of attentional performance, digit span, visuo-spatial span, line bisection task,...) [Within one week after recruitment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques universitaires Saint-Luc-UCL	Bruxelles		Belgium	1200

Sponsors and Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

• Study Director: Naïma Deggouj, Cliniques universitaires Saint-Luc-UCL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT02533739
• Other Study ID Numbers: 2014/28MAR/143
• First Posted: Aug 27, 2015
• Last Update Posted: Apr 10, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Vertigo; Vestibular Diseases

Study Results

No Results Posted as of Apr 10, 2019