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RecruitingNCT05518565CPMuscleSLUpdated Aug 26, 2022

The Muscle in Cerebral Palsy; Sarcomere Length in Vivo and Microscopic Characterization of Biopsies.

An observational study in Cerebral Palsy, Muscle Contracture and Spasticity, Muscle, sponsored by Eva Ponten. Recruiting at 3 sites in Sweden. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-08-26.

Sponsored by Eva Ponten · Observational

From the registry’s dates

  • Started Jan 2002; still recruiting 24 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
2 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Cerebral Palsy with a site in Sweden — 9 open to participants now, 10 under way, none of them phase 3. Cerebral Palsy · Sweden.

Started
2002
with 1 other
Observational
9 of 19
6 open now
Registered
11th of 19
by date
Lead sponsor
3 of 19
Eva Ponten

Among the 19 studies in Cerebral Palsy with a site in Sweden, this one is one of 2 that started in 2002, is one of 9 observational ones, and was the 11th registered.

By phase

19 studies; the count open now beside each. This study's row is marked.

No phase9 · 3 open
Observationalthis study9 · 6 open
Phase 21 · 0 open

By the year they started

First in 2002; this study’s year is marked. 2 started in 2002.

What they test

Size and results

Median enrollment 28 across the 10 interventional studies, 150 across the 9 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.

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02

Study 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.

Read the detailed description

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.

Research questions:

  • Is the muscle in CP different from muscle from typically developed children regarding architecture, protein expression and sarcomere length?
  • Is there a difference between extensors and flexors?
  • Are the contractile proteins (myosins) more altered in children with more severe CP, with a negative impact on endurance?
  • Is growth potential negatively affected?
  • Are the muscle fibers short and stretched out, contributing to poor muscle force?
  • Is an increased amount of collagen in the muscle contributing to stiffness and changes in sarcomere length? The most important measurements: Sarcomere length in vivo, muscle fiber area, histochemical morphometry, muscle fiber types (immunohistochemistry), quantification of myosins with SDH gel electrophoresis, satellite cell detection, qRT-PCR and Western blotting to exploring gene expression.
  • During surgeries that are planned according to clinical routines, muscles are that are necessary to expose in order to perform the surgery are investigated. Laser diffraction measurements are performed through the range of motion of adjacent joints. Muscle specimens 3x3 mm are taken at least 1 cm away from where the laser diffraction device (Myometer) was used.
  • The muscle specimens are snap frozen and stored at -80°C until analyzed. The expression of different myosin heavy chain (MyHC) isoforms is assessed by using the monoclonal antibodies (mAb) N2.261, mAb A4.840 against slow MyHC I, mAb F1.652 against embryonic MyHC, and mAb NCL-MHCn against fetal (=neonatal) MyHC)(Tiger, Champliaud et al. 1997; Wewer, Thornell et al. 1997). Satellite cells will be identified with mAb against N-CAM (neural cell adhesion molecule). The fibers are typed according to the content of MyHCs.

Significance: Children with cerebral palsy have a motor impairment and progressive contractures that we often treat late; when tendon and bony surgery are the only options to realign the joints. More information on the muscle architecture, composition and growth potential will give more knowledge the reasons for increasing flexion contractures in children with cerebral palsy. With this knowledge, hopefully new treatment regimens and improved surgical techniques for this patient group can be developed.

03

Conditions studied

  • Cerebral Palsy
  • Muscle Contracture
  • Spasticity, Muscle

Keywords

  • Cerebral Palsy
  • Muscle biopsy
  • Laser diffraction
  • Sarcomere Length
  • Muscle contracture
04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Children who due to clinical indications need surgery of the arm or the lower leg. Patients are consecutively recruited.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Celebral Palsy or Aquired Brain Injury

Exclusion criteria

Exclusion Criteria:

  • Progressive neurological disease
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Sarcomere lenght measurements intraooperatively in vivo with laser diffraction

    micrometer

    Time frame: One hour

  2. Muscle biopsy structure, fiber area

    square mm

    Time frame: one hour

  3. Muscle biopsy gene expression and protein content

    percentage %

    Time frame: one hour

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2002 (actual). Primary completion is estimated for Dec 2032, 371 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2022
First posted
Aug 26, 2022
StartActual
Jan 15, 2002
Primary completionEst.
Dec 15, 2032
CompletionEst.
Dec 15, 2033
Last update
Aug 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05518565
Lead sponsor
Eva Ponten
Responsible party
Eva Ponten (MD PhD Ass Prof, Region Stockholm) — Sponsor-investigator
First posted
Aug 26, 2022
Start date
Jan 15, 2002
Primary completion
Dec 15, 2032 (estimated)
Completion
Dec 15, 2033 (estimated)
Last update
Aug 26, 2022

Study contacts

Eva M Pontén, MD PhD
Contact
eva.ponten@ki.se
+46706303052
Ferdinand von Walden, MD PhD
Contact
Ferdinand.vonWalden@ki.se
Eva M Pontén, MD PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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