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VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY (VEMP)

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ClinicalTrials.gov Identifier: NCT03562676
Recruitment Status : Unknown
Verified June 2018 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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Brief Summary:

Recently, new clinical testing of saccular and utricular function have been developed and validated, the so-called vestibular-evoked myogenic potentials - VEMP (Brantberg et al. 2009, Cornell et al. 2009, Curthoys 2010, Manzari et al. 2012). Among them, the cervical VEMP (cVEMP) are short-latency electromyographic (EMG) modulations of the contracted sternocleidomastoid muscles in responses to vibration applied on the forehead. The clinical literature suggests that cVEMP are almost entirely saccular in origin (Halmagyi et al 1995).

The aim of our research is to evaluate changes in the otolith function in microgravity and hypergravity using this clinical test. Cervical vestibular-evoked myogenic potentials (cVEMP) will be recorded by surface EMG electrodes in response to bone conducted vibration to specifically assess saccular function (Halmagyi et al 1995). The primary measures will include muscle activity response amplitudes and the stimulus intensity threshold at which the cVEMP is detected.

Given that there is an off-loading of the saccules in microgravity and an increased loading in hypergravity, we hypothesize that there will be a reduction in cVEMP amplitude in microgravity and an increase in cVEMP amplitude in hypregravity compared to normal gravity. These changes in amplitude will be accompanied by changes in the threshold of the stimulus level required to elicit a cVEMP.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: weightlessness Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 30, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: weightlessness Other: weightlessness
parabolic flight


Outcome Measures
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Primary Outcome Measures :
  1. vestibular-evoked myogenic potentials (P13-N23) [ Time Frame: baseline ]
    amplitude and treshold


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers (men or women)
  • Aged from 18 to 67
  • Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
  • Who accepted to take part in the study
  • Who have given their written stated consent
  • With normal cVEMP
  • Who have passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Exclusion Criteria:

  • Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated
  • Pregnant women (urine pregnancy test for women of childbearing potential)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562676


Locations
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France
Caen University Hospital Recruiting
Caen, France
Contact: Pierre Denise, MD, PhD    0231068132 ext +33    pierre.denise@unicaen.fr   
Sponsors and Collaborators
University Hospital, Caen
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03562676    
Other Study ID Numbers: 17-161
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No