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Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Caloric Vestibular Stimulation
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Pain focused on measuring Caloric Vestibular Stimulation, Functional Imaging

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy
  • 18-65

Exclusion Criteria:

  • Contraindication to Magnetic Resonance Imaging

Sites / Locations

  • Lawson Health Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Caloric Vestibular Stimulation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 23, 2012
Last Updated
November 2, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01659073
Brief Title
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
Official Title
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 9, 2012 (Actual)
Primary Completion Date
January 30, 2013 (Actual)
Study Completion Date
September 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
There has been recent success in utilizing the non-invasive caloric vestibular stimulation as a means of modulating chronic pain. Caloric stimulation involves cooling the ear canal with either water or a cooling probe to induce vestibular stimulation. This is a technique frequently performed as part of a neurologic exam. The current theory of how caloric vestibular stimulation regulates pain is by thermosensory disinhibition. Temperatures below 25 C activate both cold thermoreceptors (Aδ fibers) and also C-nociceptors. These inputs pass in the spinothalamic tract to the thalamus, where the C-fiber input goes to the anterior cingulate cortex (ACC) and the Aδ fiber input passes to the thermosensory cortex in the dorsal posterior insula (dpIns). It is proposed that CVS reduces central pain by activating the parieto-insular vestibular cortex. As this area is anatomically adjacent to dorsal posterior insula, it may cross-activate it to suppress the ACC, or given both these cortical areas share pathways in the brainstem this may be the mechanism by which pain is suppressed. Our team has successfully demonstrated arterial spin labeling (ASL), among other functional magnetic resonance imaging modalities, to capture functional changes in cerebral processing related to pain. This utilizes the principle that increases in cerebral blood flow to a specific region of the cortex is a marker for increased functioning of this region, conversely a decrease of blood flow to a specified region is a correlate of down regulation of this specific region. We propose that ASL will be able to capture functional changes associated with caloric vestibular stimulation and better delineate the etiology of the pain augmentation. All functional studies will be conducted on a 3 Tesla scanner equipped with an 8-element, receive-only head coil. Each subject will lay in a supine position on the MRI table with their head immobilized by foam padding and a chinstrap. Every study will begin by collecting high-resolution anatomical images using a three-dimensional spoiled GRASS (Gradient Recalled Acquisition in Steady State) sequence. These structural images will be used for placement of the functional images and for anatomical atlas transformation in the image processing. The perfusion-weighted images will be acquired with a pulsed arterial spin labeling (non-invasive) approach. Once the baseline perfusion weighted functional images have been attained a continual functional image acquisition sequence will begin. During this phase the subject will have a series of three 30 second cooled ear canal irrigations separated by 60 seconds. The water will be cooled to 18 degrees Celsius using an ice water combination and standard thermometer. The irrigation will be administered at 2cc per second (total of 30cc per ear over 30 seconds) via an MRI compatible infusion pump through a modified stethoscope with perforations to ensure there is no possibility of pressure build-up within the canal. Following this series, perfusion weighted images will be collected for a subsequent 10minutes. Subjects will be welcome to discontinue from the study at any time they see fit. Each functional study will comprise 24.5 minutes. 10 minutes of baseline imaging 5.5 minutes of initial functional imaging, 4.5 min of caloric vestibular stimulation and 5.5 minutes of repeat functional imaging. Images are to be reconstructed using software written in IDL (Interactive Data Language, Research Systems, Boulder, CO). Functional image pre-processing and statistical analyses will be performed with Statistical Parametric Mapping software (SPM2, Wellcome Department of Imaging Neuroscience, University College London, UK, http://www.fil.ion.ucl.ac.uk/spm). The end data will be a measurement, in percentage change, of blood flow to specific anatomic regions of the cortex.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Caloric Vestibular Stimulation, Functional Imaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caloric Vestibular Stimulation
Arm Type
Experimental
Arm Description
Caloric vestibular stimulation performed by a modified stethescope ear attachment attached to an MRI compatible infusion pump.
Intervention Type
Procedure
Intervention Name(s)
Caloric Vestibular Stimulation
Other Intervention Name(s)
Caloric vestibular stimulation performed by a modified stethescope ear attachment attached to an MRI compatible infusion pump.
Primary Outcome Measure Information:
Title
Percent alteration to cerebral blood flow in specific anatomic regions of the cortex.
Description
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.
Time Frame
During caloric vestibular stimulation and 10min following.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy 18-65 Exclusion Criteria: Contraindication to Magnetic Resonance Imaging
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Collin F Clarke, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

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Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation

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