Clinical trial NCT02356315: Brain, Brainstem, and Spinal Cord fMRI
Official title: Investigating Pain Processing in the Brain, Brainstem, and Spinal Cord With fMRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Chronic Pain
Keywords: Brain
Brain Stem
Spinal Cord
Neurophysiology
Magnetic Resonance Imaging
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-02-05
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects and chronic neck pain patients recruited from the community

Brief summary: 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.

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.

Eligibility criteria: Healthy subjects must meet all of the following inclusion criteria to participate in this study:

1. Age between 21 and 60 years old
2. Right-handed; not currently experiencing significant pain
3. 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:

1. Age between 21 and 60 years old
2. 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:

1. Non-English speaking
2. Signs of upper extremity sensation loss; history of significant cerebrovascular disease including (but not limited to) epilepsy, stroke, tumor, multiple sclerosis, meningitis
3. History of major head trauma with sustained loss of consciousness; history of neurosurgery, ENT surgery, spine surgery, or cardiac surgery
4. History of cardiac pacemaker or neurostimulator implantation
5. 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.
6. History of alcoholism or consistent drug use; current infection or fever; pregnancy (or possible pregnancy)
7. History of metal working or injury with shrapnel or metal slivers
8. Claustrophobia
9. Piercings that are unable to be removed and tattoos older than 30 years

Primary outcomes:
measure: Functional magnetic resonance imaging
timeFrame: 1.5-2.25 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Center for Translational Imaging, Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Todd Parrish, PhD
role: PRINCIPAL_INVESTIGATOR
References: