NCT05814497 · Children's Hospital Medical Center, Cincinnati
Supraspinal Processing of Sensory Aspects of Pain
(SCP)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Multisensory Task
Reversing checkerboard, tones, and finger opposition.
OTHER
Graphesthesia
Trace numbers on skin.
OTHER
Divided attention
Divide attention between two noxious stimuli.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Cincinnati, Ohio
Collaborators
University of Barcelona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations