Supraspinal Processing of Sensory Aspects of Pain (SCP)

June 4, 2026 updated by: Robert Coghill, Children's Hospital Medical Center, Cincinnati

The goal of this basic science study is to learn about the brain mechanisms of chronic pain across different chronic pain syndromes in pediatric patients. The main questions it aims to answer are:

  • Are there shared and distinct brain systems engaged by different forms of pediatric chronic pain?
  • What are predictors of recovery from chronic pain?
  • What brain systems are associated with the spread of pain?

For this study participants will undergo:

  • Functional Magnetic Resonance Imaging (fMRI)
  • Quantitative Sensory Testing
  • Psychological Assessments

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic pain affects approximately 20% of both adults and children in the US and is a source of substantial disability and health care costs. Chronic pain can be challenging to diagnose due to the presence of poorly understood symptoms. When diagnosed, current pharmacologic treatments for pain are remarkably ineffective, while effective non-pharmacologic treatments remain under-utilized. These shortcomings in the diagnosis and treatment of pain arise from tremendous gaps in our knowledge about the basic central nervous system systems that process nociceptive information and instantiate an experience of pain. These gaps are further amplified in the case of pediatric chronic pain due to a lack of basic/translational research. The team of basic scientists and clinician scientists is uniquely positioned to perform human pediatric studies integrating functional neuroimaging with quantitative sensory testing and psychological assessments to delineate brain systems engaged during chronic pain. The study will examine four distinct chronic pain syndromes: migraine, complex regional pain syndrome, functional abdominal pain, and musculoskeletal pain. The study seeks to 1) Identify shared and distinct brain systems engaged by different forms of pediatric chronic pain, 2) Determine if predictors of recovery differ across different chronic pain conditions, 3) Delineate brain systems associated with the spread of pain. To accomplish these aims, the study will recruit 400 patients with chronic pain and 100 healthy participants (age range 10-17). The study will follow all participants longitudinally for 1 year after initiation of treatment to assess the degree of recovery and spread of pain. This basic science investigation will provide a critical foundation of basic knowledge for future clinical trials of diagnostic markers for different forms of chronic pain and for the development of new treatments for chronic pain.

Study Type

Interventional

Enrollment (Estimated)

255

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

  • Child

Accepts Healthy Volunteers

Yes

Study Population

Adolescents with chronic pain compared to controls with no chronic health conditions.

Description

Inclusion Criteria:

  • Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), diffuse MSK (widespread MSK pain), or CRPS
  • If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit.
  • Male or female, age 10 -17 (inclusive)
  • English speaking, able to complete interviews and questionnaires in English

Exclusion Criteria:

  • Weight/size incompatible with MRI scanner
  • Orthodontic braces, metallic or electronic implants, or other metal objects in the body which obscure or interfere with the MRI, or pose a risk from heating, movement, or malfunction in the MRI environment
  • Claustrophobia
  • Youth who are pregnant
  • Any comorbid rheumatic disease, diagnosis of epilepsy, other neurological diseases, or medical condition (e.g. diabetes, cancer, IBD)
  • Present psychiatric disease as defined by DSM IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, ADHD, or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study
  • Skin conditions or past skin damage on the arms or legs in or near sites of sensory testing
  • Outside the age range (9 years old or younger; 18 years or older) at the time of consent
  • History of > 1 month opioid treatment.

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Controls
Healthy controls with no history of chronic pain.
Other: Multisensory Task
Reversing checkerboard, tones, and finger opposition.
Other: Graphesthesia
Trace numbers on skin.
Other: Divided attention
Divide attention between two noxious stimuli.
Experimental: Headache and Migraine
Individuals who have migraine with headaches.
Other: Multisensory Task
Reversing checkerboard, tones, and finger opposition.
Other: Graphesthesia
Trace numbers on skin.
Other: Divided attention
Divide attention between two noxious stimuli.
Experimental: Functional Abdominal Pain Disorder (FAPD)
Individuals who have functional abdominal pain disorder.
Other: Multisensory Task
Reversing checkerboard, tones, and finger opposition.
Other: Graphesthesia
Trace numbers on skin.
Other: Divided attention
Divide attention between two noxious stimuli.
Experimental: Localized and Diffuse/Widespread Musculoskeletal Pain (MSK)
Individuals with chronic musculoskeletal pain.
Other: Multisensory Task
Reversing checkerboard, tones, and finger opposition.
Other: Graphesthesia
Trace numbers on skin.
Other: Divided attention
Divide attention between two noxious stimuli.
Experimental: Complex Regional Pain Syndrome (CRPS)
Individuals with complex regional pain syndrome.
Other: Multisensory Task
Reversing checkerboard, tones, and finger opposition.
Other: Graphesthesia
Trace numbers on skin.
Other: Divided attention
Divide attention between two noxious stimuli.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FMRI: BOLD resting connectivity of the amygdala
Time Frame: Baseline
BOLD resting connectivity of the amygdala
Baseline
Resting Cerebral Blood Flow (CBF)
Time Frame: Baseline
CBF derived from resting arterial spin labeled MRI
Baseline
FMRI: Multisensory task activity
Time Frame: Baseline
BOLD activation during multisensory task
Baseline
FMRI: Spatial task activity
Time Frame: Baseline
BOLD activation during spatial summation and divided attention
Baseline
FMRI: BOLD resting connectivity of the posterior parietal cortex
Time Frame: Baseline
BOLD resting connectivity of the posterior parietal cortex
Baseline
FMRI: Graphesthesia Activation
Time Frame: Baseline
BOLD activation during graphesthesia task
Baseline
Pain Ratings
Time Frame: Baseline
Visual analog scale (VAS) ratings of pain intensity and pain unpleasantness. The VAS is a scale of 0-10, with higher scores indicating a worse outcome.
Baseline
Pain Ratings
Time Frame: 1 Year Followup
Visual analog scale (VAS) ratings of pain intensity and pain unpleasantness. The VAS is a scale of 0-10, with higher scores indicating a worse outcome.
1 Year Followup
Spatial Distribution of Pain
Time Frame: Baseline
Body map assessment of location of pain
Baseline
Spatial Distribution of Pain
Time Frame: 1 Year Followup
Body map assessment of location of pain
1 Year Followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

University of Barcelona

Investigators

  • Principal Investigator: Robert Coghill, PhD, Children's Hospital Medical Center, Cincinnati

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 (Actual)

May 1, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data That Will Be Shared:

Data sharing represents a critical dimension of the proposed research. The data will be quite complex with psychological, psychophysical, demographic information collected outside of the scanner, and multiple modalities of MRI information collected during scanning. Accordingly, this rich dataset can be utilized for many secondary analyses. All modalities of data will be shared, with raw data included.

Formatting of Data to Facilitate Sharing:

As data is acquired, it will be named and placed into directory structures according to the BIDS standard (Brain Imaging Database Structure: http://bids.neuroimaging.io/). This standard accommodates all types of neuroimaging data to be acquired in the present proposal, and also allows for the inclusion of non-neuroimaging data such as psychological, psychophysical, and demographic information. Importantly, when data is in this format, it can be readily shared within OpenFMRI and other data warehouses

IPD Sharing Time Frame

Data will be made available after publication of key papers and will be permanently available with no expiration date.

IPD Sharing Access Criteria

After publication of key papers, data will be freely available for all researchers.

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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