NCT02979314

Brief Summary

Corroboratory behavioral evidence showed interaction effects between vestibular stimulation and egocentric transformation. The investigators here examine in healthy participants, whether there are shared brain mechanisms underlying galvanic vestibular stimulation, illusory self-motion and egocentric transformation, as well as their interaction. It is hypothesized that the GVS induced illusory self-motion dampens the ability to perform egocentric mental transformation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2017

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

August 23, 2016

Last Update Submit

October 29, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Oxygen-Level Dependent (BOLD) -signal change in response to egocentric mental transformation

    The Relative BOLD-signal change in response to egocentric mental transformation during GVS versus mental transformation during sham stimulation will be measured in an functional Magnetic Resonance Imaging (fMRI) paradigm

    one day

Study Arms (1)

Galvanic Vestibular Stimulation

EXPERIMENTAL

A standard placement of the electrodes will be used for GVS and sham, placed on the mastoids. Weak currents up to maximally 3 mA will be used (tested before in each participant individually, and expected mean current will be around 1.5 mA). Previous studies have used Magnetic Resonance (MR) compatible GVS without reporting any discomfort for the participants, however weak sensations of nausea could be possible and in case that they are disturbing for the participants the experiment will be aborted. Continuous stimulation for up to 30min with intensities of 1-1.5 mA is generally considered as safe and free of any considerable side effects.

Device: Galvanic Vestibular Stimulation

Interventions

The investigators aim to study the influence of Galvanic Vestibular Stimulation on the brain mechanisms underlying illusory self-motion and its influence on egocentric mental transformation. As a control condition sham stimulation will be applied by the same device within the same participants in different trials. Participants should not note the difference.

Galvanic Vestibular Stimulation

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Written informed consent by the participant
  • Right handed

You may not qualify if:

  • possession of metallic implants, cardiac pacemakers, neuro-stimulators, metal splinter injuries
  • claustrophobia
  • no ability to lie still in the scanner, e.g. a cold leading to frequent sneezing and subsequent head movements
  • history of neurological or psychiatric disorder
  • hearing problems
  • concomitant medication
  • strong motion sensitivity
  • vestibular deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Lars Michels, MD

    University Hospital Zurich, Div. of Neuroradiology

    PRINCIPAL INVESTIGATOR

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

August 23, 2016

First Posted

December 1, 2016

Study Start

December 1, 2016

Primary Completion

May 26, 2017

Study Completion

May 26, 2017

Last Updated

October 31, 2018

Record last verified: 2018-10