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VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY

VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03562676
Acronym
VEMP
Enrollment
9
Registered
2018-06-19
Start date
2017-11-13
Completion date
2019-12-30
Last updated
2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

OTHERweightlessness

parabolic flight

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
vestibular-evoked myogenic potentials (P13-N23)baselineamplitude and treshold

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026