Vestibular DiseasesNCT02533739
Vestibular Disorder and Visuo-spatial Functions
A study testing Cognitive and neuropsychological assesment in people with Vestibular Diseases and Vertigo, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Diseases, Vertigo
- What is being tested?
- Cognitive and neuropsychological assesment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Vestibular disorder (with or without vertigo)
- Deafness / hard of hearing
Who cannot join
- Neurological or psychiatric conditions
- Cochlear Implant (for functional magnetic resonance imaging study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Des déficits Vestibulaires Sur le développement Des Fonctions Visuo-spatiales.
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.
- Conditions
- Vestibular Diseases, Vertigo
- Being tested
- Cognitive and neuropsychological assesment
- Medical subject headings
- Vestibular Diseases, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and neuropsychological assesmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | This group will consist of vestibular patients and/or participants with vertigo. Receives: Behavioral: Cognitive and neuropsychological assesment |
| Control group | Sham comparator | This group will consist of participants without vestibular/vertigo impairments. Receives: Behavioral: Cognitive and neuropsychological assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within one week after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naïma Deggouj, Study director, Cliniques universitaires Saint-Luc-UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533739
- Sponsor's protocol ID
- 2014/28MAR/143
- Status last verified
- Apr 2019
- First submitted
- 12 Aug 2015
- Last updated
- 10 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Des déficits Vestibulaires Sur le développement Des Fonctions Visuo-spatiales.
- ClinicalTrials.gov ID
- NCT02533739
- Acronym / sponsor ID
- 2014/28MAR/143
- Conditions
- Vestibular Diseases, Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Behavioral: Cognitive and neuropsychological assesmentThis group will consist of vestibular patients and/or participants with vertigo. |
| Control group | Sham comparator | Behavioral: Cognitive and neuropsychological assesmentThis group will consist of participants without vestibular/vertigo impairments. |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Vestibular disorder (with or without vertigo)
- Deafness / hard of hearing
Key exclusion criteria (2 listed)
- Neurological or psychiatric conditions
- Cochlear Implant (for functional magnetic resonance imaging study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive and neuropsychological assesment | Behavioural | Control group, Patient group |
Primary outcome
Vestibular questionnaire (Newly developed to evaluate cognitive abilities)
Time frame: 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.
Standard computerized cognitive assessment (For example : Test of attentional performance, digit span, visuo-spatial span, line bisection task,...)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Related trials for Vestibular Diseases
Not yet recruitingPhase 2
Selumetinib for NF2-Related Schwannomatosis
Neurofibromatosis Type 2, NF2
RecruitingPhase 2
Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
Neurofibromatosis Type 2, Vestibular Schwannoma
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Recruiting
Mapping of Vestibular Centers Activation Using fMRI in Patients With Vestibular Schwannoma
Vestibular Schwannoma, Unilateral Vestibular Deficit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naïma Deggouj study director
Cliniques universitaires Saint-Luc-UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and neuropsychological assesment in people with Vestibular Diseases and Vertigo, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular questionnaire (Newly developed to evaluate cognitive abilities) (time frame: Within one week after recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.