Brain, Brainstem, and Spinal Cord fMRI

Chronic Pain Clinical Trial

Official title:

Investigating Pain Processing in the Brain, Brainstem, and Spinal Cord With fMRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356315
• Other study ID #: STU00067625
• Secondary ID: 5F32AT007800-03
• Status: Completed
• Phase: N/A
• First received: February 2, 2015
• Last updated: December 18, 2015
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Pain
• Neck Pain

Intervention

Other:
• Functional Magnetic Resonance Imaging
Functional magnetic resonance imaging will be performed to measure brain, brainstem, and spinal cord activity.

Locations

Country	Name	City	State
United States	Center for Translational Imaging, Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional magnetic resonance imaging	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	No