- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02356315
Brain, Brainstem, and Spinal Cord fMRI
December 18, 2015 updated by: Todd Parrish, Northwestern University
Investigating Pain Processing in the Brain, Brainstem, and Spinal Cord With fMRI
New advances in medical imaging have allowed for the measurement of brain activity related to chronic pain.
In addition to the brain, the investigators aim to use functional magnetic resonance imaging to investigate pain processing in the brainstem and spinal cord in healthy subjects and chronic neck pain patients.
The information gained from this study will increase the investigators understanding of how chronic pain is encoded in the nervous system and assist in developing more effective treatment strategies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The experimental design is an observational (non-interventional) cross-sectional clinical study.
The principal goal of the proposed research is to utilize functional magnetic resonance imaging to further investigate and characterize pain-related neural activity at the level of the brain, brainstem, and spinal cord in healthy subjects and chronic neck pain patients.
Healthy subjects and chronic neck pain patients will be recruited and participate in a single session of data collection.
For both the healthy and chronic neck pain groups, painful thermal stimuli will be applied over the skin of the upper extremity while whole brain, brainstem, and cervical spinal cord functional images are acquired (on separate scans).
For the chronic neck pain group, additional scans (brain, brainstem, and cervical spinal cord) will be acquired while the subjects rate their spontaneous chronic neck pain.
Study Type
Observational
Enrollment (Actual)
13
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
-
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Illinois
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Chicago, Illinois, United States, 60611
- Center for Translational Imaging, Northwestern University
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-
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
21 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy subjects and chronic neck pain patients recruited from the community
Description
Healthy subjects must meet all of the following inclusion criteria to participate in this study:
- Age between 21 and 60 years old
- Right-handed; not currently experiencing significant pain
- No history of a chronic pain syndrome such as fibromyalgia, complex regional pain syndrome, chronic low back pain, etc.
Chronic neck pain patients must meet all of the following inclusion criteria to participate in this study:
- Age between 21 and 60 years old
- Right handed; neck pain > 3 months duration; moderate neck pain score > 30 on VAS (0-100) 3) No history of a chronic pain syndrome (fibromyalgia, complex regional pain syndrome, chronic low back pain, etc.) other than chronic neck pain and its associated symptoms.
Participants meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- Non-English speaking
- Signs of upper extremity sensation loss; history of significant cerebrovascular disease including (but not limited to) epilepsy, stroke, tumor, multiple sclerosis, meningitis
- History of major head trauma with sustained loss of consciousness; history of neurosurgery, ENT surgery, spine surgery, or cardiac surgery
- History of cardiac pacemaker or neurostimulator implantation
- History of significant medical illness including cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, etc.
- History of alcoholism or consistent drug use; current infection or fever; pregnancy (or possible pregnancy)
- History of metal working or injury with shrapnel or metal slivers
- Claustrophobia
- Piercings that are unable to be removed and tattoos older than 30 years
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy subjects
Functional magnetic resonance imaging of healthy subjects
|
Functional magnetic resonance imaging will be performed to measure brain, brainstem, and spinal cord activity.
|
|
Chronic neck pain patients
Functional magnetic resonance imaging of chronic neck pain patients
|
Functional magnetic resonance imaging will be performed to measure brain, brainstem, and spinal cord activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional magnetic resonance imaging
Time Frame: 1.5-2.25 hours
|
Use functional magnetic resonance imaging to characterize brain, brainstem, and spinal cord pain processing in healthy subjects (thermal pain) and chronic neck pain patients (thermal pain and spontaneous clinical pain).
|
1.5-2.25 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Todd Parrish, PhD, Northwestern University
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)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
February 2, 2015
First Submitted That Met QC Criteria
February 4, 2015
First Posted (Estimate)
February 5, 2015
Study Record Updates
Last Update Posted (Estimate)
December 21, 2015
Last Update Submitted That Met QC Criteria
December 18, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00067625
- 5F32AT007800-03 (U.S. NIH Grant/Contract)
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.