NCT05506228 How Are the Muscles Affected in Cerebral Palsy? A Study of Muscle Biopsies Taken During Orthopaedic Surgery.
| NCT ID | NCT05506228 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eva Ponten |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2002-01-15 |
| Primary Completion | 2032-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2002-01-15 with a primary completion date of 2032-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* Cerebral palsy (CP) is a motor disorder caused by an injury to the immature brain. Even though the brain damage does not change, children with CP will have progressively weaker, shorter and stiffer muscles that will lead to contractures, bony deformations, difficulty to walk and impaired manual ability. An acquired brain injury (ABI) later during childhood, such as after a stroke or an injury, will result in similar muscle changes, and will therefore also be included in this study. For simplicity, these participants will in this text be referred to as having CP. * The mechanism for the muscle changes is still unknown. Contractures and the risk for the hips to even dislocate is now treated by tendon lengthening, muscle release and bony surgery. During these surgeries muscle biopsies, tendon biopsies and blood samples will be taken and compared with samples from typically developed (TD) children being operated for fractures, knee injuries, and deformities. The specimens will be explored regarding inflammatory markers, signaling for muscle growth, signaling for connective tissue growth and muscle and tendon pathology. In blood samples, plasma and serum, e.g. pro-inflammatory cytokines and the cytoprotective polypeptide humanin will measured, and will be correlated to the amount humanin found in muscle. With this compound information the mechanism of contracture formation may be found, and hopefully give ideas for treatment that will protect muscle and joint health, including prevention of hip dislocation and general health. * The results will be correlated to the degree of contracture of the joint and the severity of the CP (GMFCS I-V, MACS I-V). * By comparing muscle biopsies from the upper limb with muscle biopsies from the lower limb, muscles that are used in more or less automated gait will be compared to muscles in the upper limb that are used more voluntarily and irregularly. * Muscles that flex a joint, often contracted, will be compared with extensor muscles from the same patient. Fascia, aponeurosis and tendon will also be sampled when easily attainable.
Eligibility Criteria
Inclusion Criteria: * Children and adolescents undergoing clinically needed orthopaedic surgery * with Cerebral Palsy or Acquired Brain Injury * Typically developed children and adolescents (control) Exclusion Criteria: * for CP/ABI: Progressive neurological disease, other metabolic or muscle disease * for TD (Control): Cerebral Palsy, Acquired Brain injury, other metabolic or muscle diseases
Contact & Investigator
Eva M Pontén, MD PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT05506228 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05506228 currently recruiting?
Yes, NCT05506228 is actively recruiting participants. Contact the research team at eva.ponten@ki.se for enrollment information.
Where is the NCT05506228 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05506228 clinical trial?
NCT05506228 is sponsored by Eva Ponten. The principal investigator is Eva M Pontén, MD PhD at Karolinska Institutet. The trial plans to enroll 150 participants.
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