Vestibular Cortex and TMS (CoVest)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01779752
First received: January 17, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

In human, the cerebral cortex forms a network of vestibular cortical areas which functional role remains unknown. In patients with localised cortical lesions the investigator has previously demonstrated that the parieto-temporal cortex could regulate the inertial component of the vestibulo-ocular (VOR) responses whereas more ventral regions including the temporo-occipital cortex would be associated with gain regulation of these VOR responses.

The investigator's main purpose is to investigate the modalities of vestibular integration in these posterior parieto-temporal et temporo-occipital cortical regions. Thus, by using repetitive ttranscranial magnetic stimulation (rTMS) the investigator will induce a transitory inhibition of one of these 2 cortical regions and register its effect on VOR responses. Based on theta burst stimulation (TBS) paradigm, the investigator will stimulate the region of interest by applying on the scalp repetitive burst (at 50 HZ) during 44sec. Then, during the consecutive cortical inhibition lasting for the 15 minutes poststimulation, the investigator will record the subject's VOR responses. The VOR gain will be calculated and the time constant and phase will provide an estimation of the inertial component of the VOR responses. The healthy subjects recruited on the basis of inclusion criteria during medical examination will be divided into two groups of 20 subjects each depending of their sites of stimulation, temporo-parietal or temporo-occipital. Each subject will perform three experimental sessions (of 1h in average each) separated by at least one week and corresponding to : (1) the right cortical stimulation, (2) the left stimulation and (3) the vertex stimulation serving as the control session.

The TMS paradigm is used in routine in hospital and research field and had very few negative consequences (mainly transitory and occasional headache).


Condition
Cortical Organisation of Vestibular Integration.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Organisation of the Vestibular Cortical Pathways in Human: Transcranial Magnetic Stimulation (TMS) Approach

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • changes in gain of vestibulo-ocular reflex (VOR) [ Time Frame: Day 1, Day 7, Day 14, Day 21 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Subjects

Criteria

Inclusion Criteria:

  • Male and/or female healthy volunteers between 20 and 35 years old.
  • Considered healthy subject after medical examination and MRI images analysis
  • With social security affiliation
  • After informed and voluntary consent to participate to the study (signed written consent)
  • With normal ocular responses with a gain not less than 0.5 during preliminary VOR registration.

Exclusion Criteria:

  • Persons under guardianship, curatorship or any other administrative or judicial deprivation of rights and freedom
  • Persons with a medical history, or any acute or chronic disease which may affect the test results, or creating a risk to the subject in the protocol, in particular:

    • with personal or family history of seizure disorders
    • with previous or current psychiatric disease or schizotypal signs (RISC questionary)
    • with previous or current neurology or otology (audition or equilibrium) history
    • with visual corrected visual acuity inferior to 8/10
    • having taken hypnotics, psychotropic or other central nervous system depressants (opiates, barbiturates, antiepileptics, antidepressants, sedatives, antihistamines, anxiolytics, neuroleptics, clonidine and related) during the 8 months prior to experimentation
    • consuming more than 150 mg of caffeine per day (15 small cups of Italian coffee)
    • with a contra-indication for MRI: pacemaker or neural surgical clips ferromagnetic and metallic implants, intraocular foreign bodies, claustrophobia
    • pregnancy (diagnosed by a urine test)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779752

Contacts
Contact: Pierre DENISE, MD denise-p@phycog.org

Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01779752     History of Changes
Other Study ID Numbers: C12-20, 2012-A00839-34
Study First Received: January 17, 2013
Last Updated: January 28, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

ClinicalTrials.gov processed this record on September 15, 2014