Actively Recruiting

Age: 10Years - 17Years
All Genders
Healthy Volunteers
NCT03838107

Markers of Trajectory in Pediatric CRPS

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2024-02-07

126

Participants Needed

1

Research Sites

418 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Complex Regional Pain Syndrome (CRPS) is a severe and complex chronic pain condition in children. Many psychosocial factors impact its development and recovery. CRPS has a strong central component, which is reflected by structural and functional changes in the brain. However, the interaction between these cerebral changes and trajectory of recovery has been seldom investigated to date. Furthermore, interactions between cerebral changes and psychosocial factors, which might affect trajectory of recovery, are unknown. The aim of this study is to identify the psychosocial factors and cerebral changes that predict the trajectory of recovery from CRPS. Children between the ages of 10 and 17 years will be enrolled with one of their parents or legal guardians for this study. Three populations will be recruited: patients with CRPS undergoing treatment at the Functional Independence Restoration Program (FIRST), patients with CRPS undergoing treatment at the Pain Management Center and matching healthy controls. Participants will undergo three sessions: the first session will be scheduled immediately before or as soon as possible at the beginning of the patients' treatment; the second session will take place at the end of the patients' treatment; the last session will be scheduled six months post-treatment. The timing of the sessions of the healthy participants will follow a schedule similar to the FIRST patients. Each session will last approximately three hours and include acquisition of psychosocial, psychophysical, and brain imaging data in the child participants, as well as acquisition of psychosocial data in the parent participants.

CONDITIONS

Official Title

Markers of Trajectory in Pediatric CRPS

Who Can Participate

Age: 10Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 10 to 17 years
  • Fluent in English
  • Inpatients must have a CRPS diagnosis, previous unsuccessful treatment, and be starting inpatient treatment at FIRST clinic
  • Outpatients must have a CRPS diagnosis and be starting outpatient treatment at the pain management clinic
  • Healthy children must have no diagnosis of chronic pain
  • Parents must be fluent in English and have a child participating in the study
Not Eligible

You will not qualify if you...

  • Child's weight or size incompatible with MRI scanner
  • Presence of brain, neurological, or severe psychiatric abnormalities beyond those linked to chronic pain
  • Documented developmental delays or impairments
  • Any MRI contraindications such as metal implants, pregnancy, or claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

Loading map...

Research Team

M

Marie-Eve Hoeppli, PhD

CONTACT

G

Geraldine Schulze, BSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here