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

NCT05518565 | Recruiting

• 1 other identifier: CP muskel OP laser
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Cerebral Palsy; Muscle Contracture; Spasticity, Muscle

Keywords

Cerebral Palsy; Muscle biopsy; Laser diffraction; Sarcomere Length; Muscle contracture

Outcome Measures

Primary Outcomes (3)

• Sarcomere lenght measurements intraooperatively in vivo with laser diffraction

  micrometer

  One hour

• Muscle biopsy structure, fiber area

  square mm

  one hour

• Muscle biopsy gene expression and protein content

  percentage %

  one hour

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Celebral Palsy or Aquired Brain Injury

You may not qualify if:

• Progressive neurological disease

Sponsors & Collaborators

• Eva Ponten: lead

Study Sites (3)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

Karolinska University Hospitla

Stockholm, 17176, Sweden

RECRUITING

Karolinska

Stockholm, 17176, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Muscle biopsies taken during surgery

MeSH Terms

Conditions

Cerebral Palsy; Contracture; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva M Pontén, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva M Pontén, MD PhD

CONTACT

+46706303052; eva.ponten@ki.se

Ferdinand von Walden, MD PhD

CONTACT

Ferdinand.vonWalden@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD Ass Prof

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 26, 2022
• Study Start: January 15, 2002
• Primary Completion (Estimated): December 15, 2032
• Study Completion (Estimated): December 15, 2033
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

SE (3)