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Supraspinal Processing of Sensory Aspects of Pain (SCP)

Primary Purpose

Migraine in Children, Complex Regional Pain Syndromes, Musculoskeletal Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multisensory Task
Graphesthesia
Divided attention
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Migraine in Children focused on measuring chronic pain

Eligibility Criteria

10 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cincinnati Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Healthy Controls

Headache and Migraine

Functional Abdominal Pain Disorder (FAPD)

Localized and Diffuse/Widespread Musculoskeletal Pain (MSK)

Complex Regional Pain Syndrome (CRPS)

Arm Description

Healthy controls with no history of chronic pain.

Individuals who have migraine with headaches.

Individuals who have functional abdominal pain disorder.

Individuals with chronic musculoskeletal pain.

Individuals with complex regional pain syndrome.

Outcomes

Primary Outcome Measures

FMRI: BOLD resting connectivity of the amygdala
BOLD resting connectivity of the amygdala
Resting Cerebral Blood Flow (CBF)
CBF derived from resting arterial spin labeled MRI
FMRI: Multisensory task activity
BOLD activation during multisensory task
FMRI: Spatial task activity
BOLD activation during spatial summation and divided attention
FMRI: BOLD resting connectivity of the posterior parietal cortex
BOLD resting connectivity of the posterior parietal cortex
FMRI: Graphesthesia Activation
BOLD activation during graphesthesia task
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.
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.
Spatial Distribution of Pain
Body map assessment of location of pain
Spatial Distribution of Pain
Body map assessment of location of pain

Secondary Outcome Measures

Full Information

First Posted
February 10, 2023
Last Updated
September 12, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05814497
Brief Title
Supraspinal Processing of Sensory Aspects of Pain
Acronym
SCP
Official Title
Supraspinal Processing of Sensory Aspects of Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
University of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine in Children, Complex Regional Pain Syndromes, Musculoskeletal Pain, Functional Abdominal Pain Syndrome, Fibromyalgia
Keywords
chronic pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
Healthy controls with no history of chronic pain.
Arm Title
Headache and Migraine
Arm Type
Experimental
Arm Description
Individuals who have migraine with headaches.
Arm Title
Functional Abdominal Pain Disorder (FAPD)
Arm Type
Experimental
Arm Description
Individuals who have functional abdominal pain disorder.
Arm Title
Localized and Diffuse/Widespread Musculoskeletal Pain (MSK)
Arm Type
Experimental
Arm Description
Individuals with chronic musculoskeletal pain.
Arm Title
Complex Regional Pain Syndrome (CRPS)
Arm Type
Experimental
Arm Description
Individuals with complex regional pain syndrome.
Intervention Type
Other
Intervention Name(s)
Multisensory Task
Intervention Description
Reversing checkerboard, tones, and finger opposition.
Intervention Type
Other
Intervention Name(s)
Graphesthesia
Intervention Description
Trace numbers on skin.
Intervention Type
Other
Intervention Name(s)
Divided attention
Intervention Description
Divide attention between two noxious stimuli.
Primary Outcome Measure Information:
Title
FMRI: BOLD resting connectivity of the amygdala
Description
BOLD resting connectivity of the amygdala
Time Frame
Baseline
Title
Resting Cerebral Blood Flow (CBF)
Description
CBF derived from resting arterial spin labeled MRI
Time Frame
Baseline
Title
FMRI: Multisensory task activity
Description
BOLD activation during multisensory task
Time Frame
Baseline
Title
FMRI: Spatial task activity
Description
BOLD activation during spatial summation and divided attention
Time Frame
Baseline
Title
FMRI: BOLD resting connectivity of the posterior parietal cortex
Description
BOLD resting connectivity of the posterior parietal cortex
Time Frame
Baseline
Title
FMRI: Graphesthesia Activation
Description
BOLD activation during graphesthesia task
Time Frame
Baseline
Title
Pain Ratings
Description
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.
Time Frame
Baseline
Title
Pain Ratings
Description
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.
Time Frame
1 Year Followup
Title
Spatial Distribution of Pain
Description
Body map assessment of location of pain
Time Frame
Baseline
Title
Spatial Distribution of Pain
Description
Body map assessment of location of pain
Time Frame
1 Year Followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Jackson, MSc
Phone
5136360669
Email
Catherine.Jackson@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Schildmeyer, BS
Email
Hannah.Schildmeyer@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Coghill, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Jackson, MSc
Phone
513-636-0669
Email
Catherine.Jackson@cchmc.org
First Name & Middle Initial & Last Name & Degree
Hannah Schildmeyer, BS
Email
Hannah.Schildmeyer@cchmc.org
First Name & Middle Initial & Last Name & Degree
Robert Coghill, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Supraspinal Processing of Sensory Aspects of Pain

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