NCT05497609 The Muscle in Children With Cerebral Palsy - Longitudinal Exploration of Microscopic Muscle Structure.
| NCT ID | NCT05497609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eva Ponten |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2006-01-15 |
| Primary Completion | 2026-12-15 |
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 50 participants in total. It began in 2006-01-15 with a primary completion date of 2026-12-15.
⚠ 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. Since about 25 years a combination treatment with intramuscular botulinum toxin injections, braces and training has had a tremendous and increasing popularity, although lasting long-term clinical advantage is not yet proven. Muscle morphology of the biceps brachii and the gastrocnemius muscles: * The hypothesis is that care as usual, i.e. training and splinting sessions with botulinum toxin as adjuvant treatment, will reduce (normalize) the expression of the fast fatigable myosin heavy chain MyHC IIx and increase the expression of developmental myosin, as a possible sign of growth. As the biceps in the arm is used irregularly and voluntarily, and the gastrocnemius is activated during automated gait, the adaptations of those muscles will be different. Methods: Baseline muscle biopsies: Percutaneous biopsies are taken just before the first intramuscular botulinum toxin injection is given. The doses and the intervals for the botulinum toxin treatment will follow clinical routines. Biopsies 4-6 months, 12 months and 24 months after the first botulinum toxin injection: The exact same procedure as above will be performed, but the biopsies will be taken 2 cm distant, medial or lateral, from previous biopsy sites * Significance:. More knowledge is warranted regarding the actual molecular process in the muscle leading to a contracture, and its relation to the constant communication with the injured central nervous system. This study will give answers that could result in new, early prophylactic treatment of joint movement restrictions and motor impairment in children with CP.
Eligibility Criteria
Inclusion Criteria: * Cerebral Palsy, Aquired Brain Injury Exclusion Criteria: * Progressive neural disease
Contact & Investigator
Eva M Pontén, MD PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT05497609 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 NCT05497609 currently recruiting?
Yes, NCT05497609 is actively recruiting participants. Contact the research team at eva.ponten@ki.se for enrollment information.
Where is the NCT05497609 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05497609 clinical trial?
NCT05497609 is sponsored by Eva Ponten. The principal investigator is Eva M Pontén, MD PhD at Karolinska Institutet. The trial plans to enroll 50 participants.
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