NCT02358954

Brief Summary

The goal is to establish the practical usefulness of vestibular stimulation for modulating pain perception and to describe the possible mechanisms that could underlie neural vestibular-somatosensory interactions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

January 22, 2015

Last Update Submit

July 11, 2015

Conditions

Healthy

Keywords

quantitative sensory testingcontact heat evoked potentialsvection stimulation3D-turntableVolunteers

Outcome Measures

Primary Outcomes (1)

  • Pain thresholds

    The change in heat or cold pain threshold after physical vestibular stimulation and vection stimulation

    After study inclusion, Day1

Study Arms (1)

Vestibular Pain interactions

EXPERIMENTAL
Procedure: Quantitative sensory testingProcedure: CHEPSProcedure: 3D TurntableProcedure: Vection stimulation

Interventions

Quantitative sensory testingPROCEDURE

Measurement of warm and cold detection and pain thresholds

Also known as: QST
Vestibular Pain interactions
CHEPSPROCEDURE

Measurement of amplitude and latency of cortically evoked potentials

Also known as: Contact heat evoked potentials
Vestibular Pain interactions
3D TurntablePROCEDURE
Vestibular Pain interactions
Vection stimulationPROCEDURE
Vestibular Pain interactions

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Weight: 50 - 100 kg
  • Height: 155 - 185 cm
  • Male subjects 18 years to 60 years of age
  • Sufficient command of German language
  • Written informed consent by the participant after information about the project
  • Without any known history of neurological disease (especially motor, somatosensory disorders, peripheral neuropathies).
  • Right-handedness

You may not qualify if:

  • Intellectually or mental impaired subjects
  • Drug abuse
  • Chronic alcohol consumption
  • No use of marihuana 24h before measurements.
  • No history of vestibular or auditory disorders.
  • Diabetes mellitus
  • Participants of other studies during study period and 30 days prior to study begin
  • Any regular concomitant medication
  • Abnormal QST parameters at the baseline measurement.
  • Absent CHEPs-Potentials at the baseline measurement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Zurich

Zurich, Canton of Zurich, CH-8091, Switzerland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lucian M Macrea

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 9, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations

CH(1)