Development of Diffusion MRI and Tractography Technique for the Detection of Nerve Lesions in Brachial Plexus Injuries

NCT07767708 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2026-01-09

Last updated

2026-08-17

Condition(s) studied

Obstetric Brachial Plexus Palsy

Investigational drug(s) / intervention(s)

Performing an MRI

Performing an MRI: Various MRI sequences were performed (without injection) according to a new protocol developed at the ICM. This acquisition protocol consists of anatomical and diffusion sequences lasting approximately 1 hour. The acquisitions were performed in a 3T MRI scanner, in the supine position with the palms facing upwards. Gadolinium was not used in our study.

Study summary

The objective of this prospective study is to contribute to improving the management of patients with obstetric brachial plexus palsy.

The main objective is the characterization of the microstructure by diffusion MRI in patients with a history of unoperated obstetrical brachial plexus palsy.

Eligibility

Sex

ALL

Min age

14 Years

Max age

30 Years

Healthy volunteers

Inclusion Criteria: * Patients aged 14 to 30 years * Consulted by the Orthopedics Department at Armand Trousseau Hospital * Diagnosed and monitored by Armand Trousseau Hospital for obstetrical brachial plexus palsy (OBBP) * Having a single, unoperated lesion (lesions are very different and only exceptionally affect all the roots bilaterally). * Not suffering from bone or neurological pathology unrelated to OBP * Patients affiliated with or entitled to a social security scheme * Patients who have received informed information and have signed, with the investigator, a consent form to participate in the study * Parents/legal guardians who have received informed information and have co-signed, with the investigator, a consent form to participate in the study, for minor patients Exclusion Criteria: * History of rheumatoid pathologies, constitutional bone diseases, past or current pathologies affecting the arm or neck unrelated to the obstetric brachial plexus, any history of neoplasia or radiographic appearance consistent with a neoplastic fracture * Current pregnancy * Inability to perform the MRI examination (presence of a contraindication, incapacitating pain, or claustrophobia) * Large tattoo present in the area of interest (artifacts) * Patients deprived of liberty, or under guardianship/curatorship * Patients receiving medical assistance (AME)

Primary outcome measure(s)

Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP) — 3 months max.
Extraction of diffusion tensor parameters (measurement of signal anisotropy ) along the different nerves constituting the brachial plexus, reconstructed using tractography.
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP) — 3 months max.
Extraction of diffusion tensor parameters, measurement of diffusivity, along the different nerves constituting the brachial plexus, reconstructed using tractography
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP) — 3 months max.
Comparison of metrics (Anitropy Fraction, Mean Diffusion) of healthy versus injured nerves. Each plexus is manually segmented by ITK SNAP in order to extract the nerve pathways of each plexus.
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP) — 3 months max.
Description of FA, MD parameter measurements on tractography sequences along the complete pathway of the brachial plexus nerves

Trial sites (1)

Facility	City	Region	Status
Service de Chirurgie Orthopédique et Réparatrice de l'Enfant, Hôpital Armand Trousseau AP-HP	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07767708 on ClinicalTrials.gov ↗ ← All trials in France