NCT01659073

Brief Summary

The investigators propose that Arterial Spin Labelling Functional Magnetic Imaging will be able to capture functional changes associated with caloric vestibular stimulation and better delineate the etiology of the pain augmentation that has been documented with this intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Sep 2012

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

September 9, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2013

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

July 23, 2012

Last Update Submit

November 2, 2017

Conditions

Chronic Pain

Keywords

Caloric Vestibular StimulationFunctional Imaging

Outcome Measures

Primary Outcomes (1)

  • Percent alteration to cerebral blood flow in specific anatomic regions of the cortex.

    We will utilize functional imaging to determine what regions of the brain have alterations to cerebral blood flow (as a correlate for function) during caloric vestibular stimulation and then follow these changes for 10min following the intervention. There will be no follow up and no subjective data collection.

    During caloric vestibular stimulation and 10min following.

Study Arms (1)

Caloric Vestibular Stimulation

EXPERIMENTAL

Caloric vestibular stimulation performed by a modified stethescope ear attachment attached to an MRI compatible infusion pump.

Procedure: Caloric Vestibular Stimulation

Interventions

Caloric Vestibular StimulationPROCEDURE
Also known as: Caloric vestibular stimulation performed by a modified stethescope ear attachment attached to an MRI compatible infusion pump.
Caloric Vestibular Stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy

You may not qualify if:

  • Contraindication to Magnetic Resonance Imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lawson Health Research Institute

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Collin F Clarke, MD

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    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

July 23, 2012

First Posted

August 7, 2012

Study Start

September 9, 2012

Primary Completion

January 30, 2013

Study Completion

September 30, 2013

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

CA(1)