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Development of Diffusion MRI and Tractography Technique for the Detection of Nerve Lesions in Brachial Plexus Injuries (IRM-POPB)

11 août 2026 mis à jour par: Assistance Publique - Hôpitaux de Paris

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

The brachial plexus is a collection of nerve fibers that provides all sensory and motor functions of the entire upper limb. Its anatomy is particularly complex.

Obstetric brachial plexus palsy (OBP) is defined as flaccid paralysis of the upper limb, occurring at birth, related to forceful manipulation of the fetus for its delivery. This neonatal condition is not uncommon.

While most cases of OBP appear to recover spontaneously, children with incomplete recovery may have significant functional limitations related to muscle weakness, more or less associated with soft tissue retractions. Muscle weakness will induce an imbalance that can affect bone growth and joint development.

Simple stretching or neurapraxia almost always progresses spontaneously and favorably. Avulsion injuries, on the other hand, cannot heal spontaneously and therefore require surgery to restore upper limb function. The aim of this study is that DTI (Diffusion Tensor Imaging) imaging of the brachial plexus allows access to the entire brachial plexus in order to establish a lesion assessment and a powerful tool to aid in the decision for surgical exploration.

To date, there is no standard imaging technique for exploring the brachial plexus.

Diffusion tensor imaging is a new acquisition technique that tracks the movement of water molecules in all three spatial planes.

Tractography, or fiber tracking, is an acquisition and analysis technique performed using diffusion tensor imaging (DTI) MRI data.

An MRI protocol has been developed for analyzing the brachial plexus based on pilot MRI scans performed at the Brain and Spine Institute. Subjects selected for this study will undergo MRI scans using different sequences from this protocol. Image processing and tractography sequences will allow for precise analysis of the function and structure of the brachial plexus nerves and characterization of lesions in affected subjects compared to the unaffected contralateral side. The hypothesis of this research is that DTI imaging of the brachial plexus will allow a better understanding of POPB by establishing a precise lesion assessment in association with clinical data.

This is a single-center, non-randomized feasibility study involving MRI imaging analyses and requiring no changes to the patient's usual care.

Imaging data from each subject will be analyzed and statistically compared. Each patient will serve as their own control (comparison between the healthy and pathological plexus).

Imaging data from each subject can be analyzed and statistically compared.

Type d'étude

Interventionnel

Inscription (Estimé)

8

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Manon BACHY-RAZZOUK, PU-PH
  • Numéro de téléphone: 00 33 1 44 73 69 37
  • E-mail: manon.bachy@aphp.fr

Sauvegarde des contacts de l'étude

Lieux d'étude

  • France
      • Paris, France, 75012
        • Recrutement
        • Service de Chirurgie Orthopédique et Réparatrice de l'Enfant, Hôpital Armand Trousseau AP-HP
        • Contact:
          • Manon BACCHY-RAZZOUK, PU-PH
          • Numéro de téléphone: 00 33 1 44 73 69 37
          • E-mail: manon.bachy@aphp.fr
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Non

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: One group
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Délai: 3 months max.
Extraction of diffusion tensor parameters (measurement of signal anisotropy ) along the different nerves constituting the brachial plexus, reconstructed using tractography.
3 months max.
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Délai: 3 months max.
Extraction of diffusion tensor parameters, measurement of diffusivity, along the different nerves constituting the brachial plexus, reconstructed using tractography
3 months max.
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Délai: 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.
3 months max.
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Délai: 3 months max.
Description of FA, MD parameter measurements on tractography sequences along the complete pathway of the brachial plexus nerves
3 months max.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Determination of the anatomical location of POPB lesions (trunk, terminal branches, etc.) in comparison with the contralateral healthy side of the patients
Délai: 3 months max.
Compare by MRI diffusion anatomical and diffusion measurements between different subjects
3 months max.
Analyze the plexus fibers altered by the neuroma in the affected plexuses
Délai: 3 months max.
Analysis of the qualitative characteristics of the axons studied in the plexus area of the neuroma in affected subjects (visual analysis of the roots affected by the neuroma compared with the healthy side, as well as measurement of the volumes in voxels)
3 months max.
Analyze the plexus fibers altered by the neuroma in the affected plexuses
Délai: 3 months max.
Analysis of the quantitative characteristics of the axons studied in the plexus area of the neuroma in affected subjects (fractional anisotropy, mean diffusion, axial diffusion and radial diffusion)
3 months max.
Establish anatomoclinical relationships with the data from the specific and in-depth clinical examination carried out in consultation
Délai: 3 months max.
Analysis of the apparent lesions visible on MRI
3 months max.
Analyze the feasibility of the DTI MRI acquisition protocol
Délai: 3 months max.
Feasibility : acquisition time (the acquisition time required to obtain image quality sufficient for post-MRI analysis),
3 months max.
Analyze the feasibility of the DTI MRI acquisition protocol
Délai: 3 months max.
Feasibility: imaging quality
3 months max.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Assistance Publique - Hôpitaux de Paris

Les enquêteurs

  • Chercheur principal: Manon BACHY-RAZZOUK, PU-PH, Assistance Publique - Hôpitaux de Paris

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 janvier 2026

Achèvement primaire (Estimé)

1 janvier 2027

Achèvement de l'étude (Estimé)

1 février 2027

Dates d'inscription aux études

Première soumission

24 juin 2025

Première soumission répondant aux critères de contrôle qualité

11 août 2026

Première publication (Réel)

17 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • APHP211551
  • IDRCB: 2024-A02069-38 (Autre identifiant: ANSM)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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