VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY

Healthy Volunteers Clinical Trial

— VEMP  

Official title:

VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03562676
• Other study ID #: 17-161
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2018
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: December 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• weightlessness
parabolic flight

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vestibular-evoked myogenic potentials (P13-N23)	amplitude and treshold	baseline