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Completed

NCT Number: NCT05403034

Study of the Biological Function of Muscle Satellite Cells From Patients With Obstetric Brachial Plexus Palsy

The purpose of this prospective work is to study the consequences of obstetrical brachial plexus paralysis on the rotator muscles of the shoulder. The hypothesis is that shoulder stiffness of these children is due to an impairment of the shoulder rotator muscles. The investigators want to test the regenerative capacities of these muscles. The development of a cellular model of this pathology will allow to test new therapeutic perspectives and to validate our hypothesis.

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Key information

About this study

During delivery, there can be a lesion of the nerve roots of the brachial plexus (cervical C5-C8 and/or thoracic T1 roots). The newborn presents at birth a paralysis of the arm (Obstetrical Brachial Plexus Paralysis: OBPP). One third of children with OBPP will have sequelae despite daily rehabilitation. The most frequent disability is shoulder stiffness. The current hypothesis is that this stiffness is due to a permanent imbalance between the affected shoulder muscles (lateral rotators) and the muscles less affected by the paralysis (medial rotators). Because of this imbalance, the injured shoulder is spontaneously positioned in medial rotation. This position would lead to retractions at the front of the joint despite rehabilitation. In case of incomplete recovery, growth disorders of the shoulder joint (dysplasia) appear as well as a functional handicap.

The management, from the age of 2 years, in case of shoulder stiffness and dysplasia, is surgery (arthrolysis) to regain mobility. During this operation, a muscle transfer can also be performed to strengthen the lateral rotator muscles.

However, despite surgery, mobility deficits often recur within a few years. To understand the origin of the lateral and medial rotation deficits, the investigators conducted an anatomopathological study of the rotator muscles in these children. The preliminary results show a significant damage of the rotator muscles with the presence of fibrosis which could explain the rotational stiffness and the functional impairment. To better understand the pathophysiological mechanisms, the investigatorswill set up an OBPP model in cell culture to understand the regenerative capacities and to test new pharmacological approaches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • OBPP children with a planned shoulder surgery (arthrolysis and/or muscle transfer).

Exclusion criteria

  • other neurological disorders, post-traumatic shoulder stiffness

Treatment and study plan

Muscle biopsy

Procedure

Peroperative muscle biopsy will be performed during a planned shoulder surgery (arthrolysis and/or muscle transfer)

Other names: Shoulder arthrolysis, Shoulder muscle transfer

Primary outcomes

  1. Assessment of muscle regeneration capacity: proliferation capacity

    Time frame: 30 days

    Proliferation capacity of satellite cells assessed by immunofluorescence: percentage of Pax 7 positive cells/total desmin positive cells

  2. assessment of muscle regeneration capacity: differenciation capacity

    Time frame: 30 days

    Differentiation capacity of satellite cells assessed by histology: fusion index (number of nuclei in a myotubule compared to total number of nuclei in the sample) in percentage

Secondary outcomes

  1. Effect of botulinum toxin on the proliferation potential of satellite cells: proliferation capacity

    Time frame: 30 days

    Proliferation capacity of satellite cells assessed by immunofluorescence: percentage of Pax 7 positive cells/total desmin positive cells.

  2. Effect of botulinum toxin on the proliferation potential of satellite cells: differentiation capacity

    Time frame: 30 days

    Differentiation capacity of satellite cells assessed by histology: fusion index (number of nuclei in a myotubule compared to total number of nuclei in the sample) in percentage

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Study of the Biological Function of Muscle Satellite Cells From Patients With Obstetric Brachial Plexus Palsy Satellite Cell Obstetrical PlExus (SCOPE)

Acronym: SCOPE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2022
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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