Brain, Brainstem, and Spinal Cord fMRI

NCT ID: NCT02356315

Last Updated: 2015-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neck Pain Chronic Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Brain Brain Stem Spinal Cord Neurophysiology Magnetic Resonance Imaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy subjects

Functional magnetic resonance imaging of healthy subjects

Functional Magnetic Resonance Imaging

Intervention Type OTHER

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

Intervention Type OTHER

Functional magnetic resonance imaging will be performed to measure brain, brainstem, and spinal cord activity.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Functional Magnetic Resonance Imaging

Functional magnetic resonance imaging will be performed to measure brain, brainstem, and spinal cord activity.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.


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.

Exclusion Criteria

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Todd Parrish

Professor, Department of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Todd Parrish, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Translational Imaging, Northwestern University

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5F32AT007800-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00067625

Identifier Type: -

Identifier Source: org_study_id