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Brain, Brainstem, and Spinal Cord fMRI

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ClinicalTrials.gov Identifier: NCT02356315
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : December 21, 2015
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Todd Parrish, Northwestern University

Tracking Information
First Submitted Date February 2, 2015
First Posted Date February 5, 2015
Last Update Posted Date December 21, 2015
Study Start Date January 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2015)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02356315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain, Brainstem, and Spinal Cord fMRI
Official Title Investigating Pain Processing in the Brain, Brainstem, and Spinal Cord With fMRI
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.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy subjects and chronic neck pain patients recruited from the community
Condition
  • Neck Pain
  • Chronic Pain
Intervention Other: Functional Magnetic Resonance Imaging
Functional magnetic resonance imaging will be performed to measure brain, brainstem, and spinal cord activity.
Study Groups/Cohorts
  • Healthy subjects
    Functional magnetic resonance imaging of healthy subjects
    Intervention: Other: Functional Magnetic Resonance Imaging
  • Chronic neck pain patients
    Functional magnetic resonance imaging of chronic neck pain patients
    Intervention: Other: Functional Magnetic Resonance Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 18, 2015)
13
Original Estimated Enrollment
 (submitted: February 4, 2015)
30
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02356315
Other Study ID Numbers STU00067625
5F32AT007800-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Todd Parrish, Northwestern University
Study Sponsor Northwestern University
Collaborators National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Todd Parrish, PhD Northwestern University
PRS Account Northwestern University
Verification Date December 2015