Vestibular Pain Interactions | NCT02358954

Studies
Vestibular Pain Interactions

NCT02358954

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jul 14, 2015Estimated

Enrollment

26Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Quantitative sensory testing
CHEPS
3D Turntable
Vection stimulation

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jan 22, 2015

First Submission Date that Met QC Criteria

Feb 3, 2015

First Posted Date

Feb 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2015

Last Update Posted Date

Jul 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vestibular Pain interactions	Experimental		Procedure: Quantitative sensory testing Procedure: CHEPS Procedure: 3D Turntable Procedure: Vection stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quantitative sensory testing	Procedure	Measurement of warm and cold detection and pain thresholds	Vestibular Pain interactions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain thresholds	The change in heat or cold pain threshold after physical vestibular stimulation and vection stimulation	After study inclusion, Day1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Zurich		Zurich	Canton of Zurich	CH-8091	Switzerland