VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY

NCT03562676 | Unknown

• 1 other identifier: 17-161
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• vestibular-evoked myogenic potentials (P13-N23)

  amplitude and treshold

  baseline

Study Arms (1)

weightlessness

EXPERIMENTAL

Other: weightlessness

Interventions

weightlessness OTHER

parabolic flight

weightlessness

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women (urine pregnancy test for women of childbearing potential)

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

MeSH Terms

Interventions

Weightlessness

Intervention Hierarchy (Ancestors)

Hypogravity; Gravity, Altered; Gravitation; Astronomical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 19, 2018
• Study Start: November 13, 2017
• Primary Completion: November 30, 2019
• Study Completion: December 30, 2019
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)