NCT02533739

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 12, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

August 12, 2015

Last Update Submit

April 8, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Within one week after recruitment

  • 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.

    Within one week after recruitment

Study Arms (2)

Patient group

EXPERIMENTAL

This group will consist of vestibular patients and/or participants with vertigo.

Behavioral: Cognitive and neuropsychological assesment

Control group

SHAM COMPARATOR

This group will consist of participants without vestibular/vertigo impairments.

Behavioral: Cognitive and neuropsychological assesment

Interventions

Control groupPatient group

Eligibility Criteria

Age2 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Vestibular disorder (with or without vertigo)
  • Deafness / hard of hearing

You may not qualify if:

  • Neurological or psychiatric conditions
  • Cochlear Implant (for functional magnetic resonance imaging study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc-UCL

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Vestibular DiseasesVertigo

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Naïma Deggouj

    Cliniques universitaires Saint-Luc-UCL

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 27, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations