NCT05518565 The Muscle in Cerebral Palsy; Sarcomere Length in Vivo and Microscopic Characterization of Biopsies.
| NCT ID | NCT05518565 |
| 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 impairment due to a brain malformation or a brain lesion before the age of two. Spasticity, hypertonus in flexor muscles, dyscoordination and an impaired sensorimotor control are cardinal symptoms. The brain lesion is non-progressive, but the flexor muscles of the limbs will during adolescence become relatively shorter and shorter (contracted), forcing the joints into a progressively flexed position. This will worsen the positions of already paretic and malfunctioning arms and legs. Due to bending forces across the joints, bony malformations will occur, worsening the function even further. Currently, the initial treatment of choice is the use of braces, which diminishes the shortening somewhat, but eventually lengthenings of tendons and release of aponeuroses around the muscles often is needed, and transfers of wrist flexors to wrist extensors may improve wrist position. But the long-term results are unpredictable- how much does the muscle need to be lengthened? What muscles should be transferred for a better position of the wrist, and at what tension? A method to measure sarcomere length in vivo has been developed. The sarcomere, the distance between two striations, is the smallest contractile unit in the striated muscle. When, during surgery, a muscle fiber bundle is transilluminated with a low energy laser light, a diffraction pattern is formed. This diffraction pattern reflects the sarcomere length, and thereby an instant measure of how the stretch of the muscle is obtained. When performing tendon transfers of e.g. wrist flexors to wrist extensors, the setting of the tension of the transfer is arbitrary, and the long-term result is unpredictable. Laser diffraction measurements will give a guide to a precise setting of tension. It is known that there may be pathological changes in muscle in cerebral palsy that also will affect the long-term results of tendon lengthenings and transfers. In order to also take these changes into account, small muscle biopsies will be taken during the same surgeries. These will be examined with immuno-histochemical and biochemical techniques, gel-electrophoresis as well as electron microscopy.
Eligibility Criteria
Inclusion Criteria: * Celebral Palsy or Aquired Brain Injury Exclusion Criteria: * Progressive neurological disease
Contact & Investigator
Eva M Pontén, MD PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT05518565 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 NCT05518565 currently recruiting?
Yes, NCT05518565 is actively recruiting participants. Contact the research team at eva.ponten@ki.se for enrollment information.
Where is the NCT05518565 trial being conducted?
This trial is being conducted at Stockholm, Sweden, Stockholm, Sweden, Stockholm, Sweden.
Who is sponsoring the NCT05518565 clinical trial?
NCT05518565 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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