Clinical trial NCT05403034: Study of the Biological Function of Muscle Satellite Cells From Patients With Obstetric Brachial Plexus Palsy
Official title: Study of the Biological Function of Muscle Satellite Cells From Patients With Obstetric Brachial Plexus Palsy Satellite Cell Obstetrical PlExus (SCOPE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstetrical Brachial Plexus Palsy
Keywords: Brachial plexus
Neonatal brachial plexus palsy
Denervation
Muscle atrophy
Muscle regeneration
Botulinum toxin
Satellite cell
Primary human muscle cell culture
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-06-03
Enrollment: 8
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* other neurological disorders, post-traumatic shoulder stiffness

Primary outcomes:
measure: Assessment of muscle regeneration capacity: proliferation capacity
timeFrame: 30 days
measure: assessment of muscle regeneration capacity: differenciation capacity
timeFrame: 30 days
Secondary outcomes:
measure: Effect of botulinum toxin on the proliferation potential of satellite cells: proliferation capacity
timeFrame: 30 days
measure: Effect of botulinum toxin on the proliferation potential of satellite cells: differentiation capacity
timeFrame: 30 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Chu Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Marion DELPONT, Dr
role: PRINCIPAL_INVESTIGATOR
References: