VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY

NCT ID: NCT03562676

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-13
• Study Completion Date: 2019-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

weightlessness

Group Type: EXPERIMENTAL

weightlessness

Intervention Type: OTHER

parabolic flight

Interventions

weightlessness

parabolic flight

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Caen University Hospital

Caen, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Pierre Denise, MD, PhD

Role: primary

pierre.denise@unicaen.fr

0231068132 ext. +33

Other Identifiers

17-161

Identifier Type: -

Identifier Source: org_study_id