Supraspinal Processing of Sensory Aspects of Pain
SCP
1 other identifier
interventional
350
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
July 1, 2025
January 1, 2025
4.2 years
February 10, 2023
June 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
FMRI: BOLD resting connectivity of the amygdala
BOLD resting connectivity of the amygdala
Baseline
Resting Cerebral Blood Flow (CBF)
CBF derived from resting arterial spin labeled MRI
Baseline
FMRI: Multisensory task activity
BOLD activation during multisensory task
Baseline
FMRI: Spatial task activity
BOLD activation during spatial summation and divided attention
Baseline
FMRI: BOLD resting connectivity of the posterior parietal cortex
BOLD resting connectivity of the posterior parietal cortex
Baseline
FMRI: Graphesthesia Activation
BOLD activation during graphesthesia task
Baseline
Pain Ratings
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
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
Body map assessment of location of pain
Baseline
Spatial Distribution of Pain
Body map assessment of location of pain
1 Year Followup
Study Arms (5)
Healthy Controls
EXPERIMENTALHealthy controls with no history of chronic pain.
Headache and Migraine
EXPERIMENTALIndividuals who have migraine with headaches.
Functional Abdominal Pain Disorder (FAPD)
EXPERIMENTALIndividuals who have functional abdominal pain disorder.
Localized and Diffuse/Widespread Musculoskeletal Pain (MSK)
EXPERIMENTALIndividuals with chronic musculoskeletal pain.
Complex Regional Pain Syndrome (CRPS)
EXPERIMENTALIndividuals with complex regional pain syndrome.
Interventions
Reversing checkerboard, tones, and finger opposition.
Trace numbers on skin.
Divide attention between two noxious stimuli.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Coghill, PhD
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 10, 2023
First Posted
April 18, 2023
Study Start
May 1, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
July 1, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Data will be made available after publication of key papers and will be permanently available with no expiration date.
- Access Criteria
- After publication of key papers, data will be freely available for all researchers.
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