- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02358954
Vestibular Pain Interactions (VPI)
July 11, 2015 updated by: Lucian Macrea, University of Zurich
Modulation of Pain Responses by Vestibular Stimulation. A Contact Heat Evoked Potential Study.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, CH-8091
- University Hospital Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vestibular Pain interactions
|
Measurement of warm and cold detection and pain thresholds
Other Names:
Measurement of amplitude and latency of cortically evoked potentials
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain thresholds
Time Frame: After study inclusion, Day1
|
The change in heat or cold pain threshold after physical vestibular stimulation and vection stimulation
|
After study inclusion, Day1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
January 22, 2015
First Submitted That Met QC Criteria
February 3, 2015
First Posted (Estimate)
February 9, 2015
Study Record Updates
Last Update Posted (Estimate)
July 14, 2015
Last Update Submitted That Met QC Criteria
July 11, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VPI01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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