HealthyVPINCT02358954
Vestibular Pain Interactions
A study testing Quantitative sensory testing, CHEPS and 3D Turntable in people with Healthy, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Quantitative sensory testing, CHEPS and 3D Turntable
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University hospital Zurich
Zurich, Canton of Zurich, CH-8091
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Quantitative sensory testing, CHEPS, 3D Turntable, Vection stimulation
- Keywords
- quantitative sensory testing, contact heat evoked potentials, vection stimulation, 3D-turntable, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative sensory testingProcedure or surgery
Also called QST
Measurement of warm and cold detection and pain thresholds
CHEPSProcedure or surgery
Also called Contact heat evoked potentials
Measurement of amplitude and latency of cortically evoked potentials
3D TurntableProcedure or surgery
Vection stimulationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Pain interactions | Experimental | Not described Receives: Procedure: Quantitative sensory testing; Procedure: CHEPS; Procedure: 3D Turntable; Procedure: Vection stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain thresholds
The change in heat or cold pain threshold after physical vestibular stimulation and vection stimulation
Measured: After study inclusion, Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucian Macrea, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358954
- Sponsor's protocol ID
- VPI01
- Acronym
- VPI
- Status last verified
- Jul 2015
- First submitted
- 22 Jan 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Pain Responses by Vestibular Stimulation. A Contact Heat Evoked Potential Study.
- ClinicalTrials.gov ID
- NCT02358954
- Acronym / sponsor ID
- VPI / VPI01
- Conditions
- Healthy
- Keywords
- quantitative sensory testing, contact heat evoked potentials, vection stimulation, 3D-turntable, Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vestibular Pain interactions | Experimental | Procedure: Quantitative sensory testing, Procedure: CHEPS, Procedure: 3D Turntable, Procedure: Vection stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Intellectually or mental impaired subjects
- Drug abuse
- Chronic alcohol consumption
- No use of marihuana 24h before measurements.
- No history of vestibular or auditory disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative sensory testingAlso: QSTMeasurement of warm and cold detection and pain thresholds | Procedure or surgery | Vestibular Pain interactions |
| CHEPSAlso: Contact heat evoked potentialsMeasurement of amplitude and latency of cortically evoked potentials | Procedure or surgery | Vestibular Pain interactions |
| 3D Turntable | Procedure or surgery | Vestibular Pain interactions |
| Vection stimulation | Procedure or surgery | Vestibular Pain interactions |
Primary outcome
Pain thresholds
Time frame: After study inclusion, Day1
The change in heat or cold pain threshold after physical vestibular stimulation and vection stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative sensory testing, CHEPS and 3D Turntable in people with Healthy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain thresholds (time frame: After study inclusion, Day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.