How Are the Muscles Affected in Cerebral Palsy? A Study of Muscle Biopsies Taken During Orthopaedic Surgery.

NCT05506228 | Recruiting

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

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.

Conditions

Cerebral Palsy; Muscle; Muscle Contracture; Muscle Spasticity

Keywords

Cerebral Palsy; Upper Limb; Lower Limb; Muscle Biopsy; Plasma

Outcome Measures

Primary Outcomes (3)

• Muscle/tendon morphology

  morphology classification

  2002- 2027

• Muscle metabolism

  NADH staining classification

  2002- 2027

• Fiber area

  um 2, square micrometer

  2002- 2027

Secondary Outcomes (1)

• Clinical data, Contracture

  Pre-OP

Study Arms (2)

Cerebral Palsy (CP) / Acquired Brain Injury (ABI)

Children and adolescents with cerebral palsy and acquired brain injury.

Other: No intervention

TD (Typically Developed)

Typically developed children and adolescents.

Other: No intervention

Interventions

No intervention OTHER

Cerebral Palsy (CP) / Acquired Brain Injury (ABI); TD (Typically Developed)

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled for clinically needed orthopaedic surgery.

You may qualify if:

• Children and adolescents undergoing clinically needed orthopaedic surgery
• with Cerebral Palsy or Acquired Brain Injury
• Typically developed children and adolescents (control)

You may not qualify if:

• for CP/ABI: Progressive neurological disease, other metabolic or muscle disease
• for TD (Control): Cerebral Palsy, Acquired Brain injury, other metabolic or muscle diseases

Sponsors & Collaborators

• Eva Ponten: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Muscle and tendon biopsies. Blood samples for serum and plasma analyses

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: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 18, 2022
• Study Start: January 15, 2002
• Primary Completion (Estimated): December 15, 2032
• Study Completion (Estimated): December 15, 2033
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

SE (1)