Migraine in ChildrenSCPNCT05814497
Supraspinal Processing of Sensory Aspects of Pain
A study testing Multisensory Task, Graphesthesia and Divided attention in people with Migraine in Children and Complex Regional Pain Syndromes, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine in Children, Complex Regional Pain Syndromes, Musculoskeletal Pain
- What is being tested?
- Multisensory Task, Graphesthesia and Divided attention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hannah Schildmeyer, BS contact
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Catherine Jackson, MSc, 513-636-0669, Catherine.Jackson@cchmc.org
Hannah Schildmeyer, BS, Hannah.Schildmeyer@cchmc.org
About this study
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
Read the 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.
- Conditions
- Migraine in Children, Complex Regional Pain Syndromes, Musculoskeletal Pain, Functional Abdominal Pain Syndrome, Fibromyalgia
- Being tested
- Multisensory Task, Graphesthesia, Divided attention
- Keywords
- chronic pain
- Medical subject headings
- Complex Regional Pain Syndromes, Musculoskeletal Pain, Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory TaskOther
Reversing checkerboard, tones, and finger opposition.
GraphesthesiaOther
Trace numbers on skin.
Divided attentionOther
Divide attention between two noxious stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | Healthy controls with no history of chronic pain. Receives: Other: Multisensory Task; Other: Graphesthesia; Other: Divided attention |
| Headache and Migraine | Experimental | Individuals who have migraine with headaches. Receives: Other: Multisensory Task; Other: Graphesthesia; Other: Divided attention |
| Functional Abdominal Pain Disorder (FAPD) | Experimental | Individuals who have functional abdominal pain disorder. Receives: Other: Multisensory Task; Other: Graphesthesia; Other: Divided attention |
| Localized and Diffuse/Widespread Musculoskeletal Pain (MSK) | Experimental | Individuals with chronic musculoskeletal pain. Receives: Other: Multisensory Task; Other: Graphesthesia; Other: Divided attention |
| Complex Regional Pain Syndrome (CRPS) | Experimental | Individuals with complex regional pain syndrome. Receives: Other: Multisensory Task; Other: Graphesthesia; Other: Divided attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMRI: BOLD resting connectivity of the amygdala
BOLD resting connectivity of the amygdala
Measured: Baseline
Resting Cerebral Blood Flow (CBF)
CBF derived from resting arterial spin labeled MRI
Measured: Baseline
FMRI: Multisensory task activity
BOLD activation during multisensory task
Measured: Baseline
FMRI: Spatial task activity
BOLD activation during spatial summation and divided attention
Measured: Baseline
FMRI: BOLD resting connectivity of the posterior parietal cortex
BOLD resting connectivity of the posterior parietal cortex
Measured: Baseline
FMRI: Graphesthesia Activation
BOLD activation during graphesthesia task
Measured: 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.
Measured: 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.
Measured: 1 Year Followup
Spatial Distribution of Pain
Body map assessment of location of pain
Measured: Baseline
Spatial Distribution of Pain
Body map assessment of location of pain
Measured: 1 Year Followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 May 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Principal investigator, Robert Coghill, Children's Hospital Medical Center, Cincinnati
- Investigators
- Robert Coghill, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814497
- Sponsor's protocol ID
- 2022-0556
- Acronym
- SCP
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supraspinal Processing of Sensory Aspects of Pain
- ClinicalTrials.gov ID
- NCT05814497
- Acronym / sponsor ID
- SCP / 2022-0556
- Conditions
- Migraine in Children, Complex Regional Pain Syndromes, Musculoskeletal Pain, Functional Abdominal Pain Syndrome, Fibromyalgia
- Keywords
- chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Other: Multisensory Task, Other: Graphesthesia, Other: Divided attentionHealthy controls with no history of chronic pain. |
| Headache and Migraine | Experimental | Other: Multisensory Task, Other: Graphesthesia, Other: Divided attentionIndividuals who have migraine with headaches. |
| Functional Abdominal Pain Disorder (FAPD) | Experimental | Other: Multisensory Task, Other: Graphesthesia, Other: Divided attentionIndividuals who have functional abdominal pain disorder. |
| Localized and Diffuse/Widespread Musculoskeletal Pain (MSK) | Experimental | Other: Multisensory Task, Other: Graphesthesia, Other: Divided attentionIndividuals with chronic musculoskeletal pain. |
| Complex Regional Pain Syndrome (CRPS) | Experimental | Other: Multisensory Task, Other: Graphesthesia, Other: Divided attentionIndividuals with complex regional pain syndrome. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisensory TaskReversing checkerboard, tones, and finger opposition. | Other | Complex Regional Pain Syndrome (CRPS), Functional Abdominal Pain Disorder (FAPD), Headache and Migraine, Healthy Controls, Localized and Diffuse/Widespread Musculoskeletal Pain (MSK) |
| GraphesthesiaTrace numbers on skin. | Other | Complex Regional Pain Syndrome (CRPS), Functional Abdominal Pain Disorder (FAPD), Headache and Migraine, Healthy Controls, Localized and Diffuse/Widespread Musculoskeletal Pain (MSK) |
| Divided attentionDivide attention between two noxious stimuli. | Other | Complex Regional Pain Syndrome (CRPS), Functional Abdominal Pain Disorder (FAPD), Headache and Migraine, Healthy Controls, Localized and Diffuse/Widespread Musculoskeletal Pain (MSK) |
Primary outcome
FMRI: BOLD resting connectivity of the amygdala
Time frame: Baseline
BOLD resting connectivity of the amygdala
Resting Cerebral Blood Flow (CBF)
Time frame: Baseline
CBF derived from resting arterial spin labeled MRI
FMRI: Multisensory task activity
Time frame: Baseline
BOLD activation during multisensory task
FMRI: Spatial task activity
Time frame: Baseline
BOLD activation during spatial summation and divided attention
FMRI: BOLD resting connectivity of the posterior parietal cortex
Time frame: Baseline
BOLD resting connectivity of the posterior parietal cortex
FMRI: Graphesthesia Activation
Time frame: Baseline
BOLD activation during graphesthesia task
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.
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.
Spatial Distribution of Pain
Time frame: Baseline
Body map assessment of location of pain
Spatial Distribution of Pain
Time frame: 1 Year Followup
Body map assessment of location of pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannah Schildmeyer, BS contact
Robert Coghill, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory Task, Graphesthesia and Divided attention in people with Migraine in Children and Complex Regional Pain Syndromes, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Jackson, MSc (5136360669, Catherine.Jackson@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMRI: BOLD resting connectivity of the amygdala (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.