- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04788134
Post- Rotatory Nystagmus Test: Normative Data for Spanish Adolescents and Adults
Normative Data for Post-rotatory Nystagmus Test at Spanish Adolescent and Adult Population: a Transversal Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The vestibulo-ocular reflex (VOR) is the motor response of our eyes in the opposite direction to a translational or rotational movement of our head. The post-rotational nystagmus test (PRN) assesses the integrity of this reflex, thus assessing the perception of the vestibular system. This system has an important role in our balance, stabilization of the visual field when our head moves, awareness of the position of our head in space, postural control and functions of the Autonomous Nervous System.
The duration of this reflex after administering this test has been widely studied in children from 2 months to 12 years and 11 months of age. However, there is a knowledge gap from that age that the present study seeks to address. This article aims to explore the use of the PRN test for adolescent and adults, to prove if the duration of the VOR is longer in these population than in children. It will be also recollected personal data to study whether exposure to vestibular input influences its reactivity and perception.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Vico Rocío
- Phone Number: +34 658144741
- Email: rociovicoquesada@gmail.com
Study Contact Backup
- Name: Pedrero Yolanda
- Phone Number: + 34 697355054
- Email: yolandapedmar@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- People over 13 years of age.
- Spanish-speaking population.
- Signature of the informed consent.
Exclusion Criteria:
- Diagnosis of a neurodevelopmental or neurological disorder.
- Being in occupational therapeutic treatment for balance or vestibular problems.
- Practice of sports in one previous hour.
- Adverse reaction to vestibular input such as vomiting, discoloration, feeling of unpleasantness or any other type of negative reaction before / during / after the administration of the NPR.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of vestibular-ocular reflex after the administration of nystagmus post-rotatory test in adolescent and adult population
Time Frame: End of the nystagmus post rotatory test and end of the vestibular-ocular reflex
|
The post rotatory nystagmus test evaluates the duration of the vestibular-ocular reflex: how long its lats gives information about the perception of vestibular system.
This reflex reflects the role of the vestibular system in ocular mechanisms (Mailloux et al., 2014).
It is administered twice: clockwise and counterclockwise.After the administration the physiologic nystagmus appears, it is our vestibular-ocular reflex, and the examiner has to register the duration of it.
|
End of the nystagmus post rotatory test and end of the vestibular-ocular reflex
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vico Rocío, Quesada, Rocío Vico
- Principal Investigator: Pedrero Yolanda, Quesada, Rocío Vico
- Principal Investigator: Zisa Nerina, Quesada, Rocío Vico
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010395
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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