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

11 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

8

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Manon BACHY-RAZZOUK, PU-PH
  • Numero di telefono: 00 33 1 44 73 69 37
  • Email: manon.bachy@aphp.fr

Backup dei contatti dello studio

Luoghi di studio

  • Francia
      • Paris, Francia, 75012
        • Reclutamento
        • Service de Chirurgie Orthopédique et Réparatrice de l'Enfant, Hôpital Armand Trousseau AP-HP
        • Contatto:
          • Manon BACCHY-RAZZOUK, PU-PH
          • Numero di telefono: 00 33 1 44 73 69 37
          • Email: manon.bachy@aphp.fr
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: One group
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 3 months max.
Description of FA, MD parameter measurements on tractography sequences along the complete pathway of the brachial plexus nerves
3 months max.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Determination of the anatomical location of POPB lesions (trunk, terminal branches, etc.) in comparison with the contralateral healthy side of the patients
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 3 months max.
Analysis of the apparent lesions visible on MRI
3 months max.
Analyze the feasibility of the DTI MRI acquisition protocol
Lasso di tempo: 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
Lasso di tempo: 3 months max.
Feasibility: imaging quality
3 months max.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigatori

  • Investigatore principale: Manon BACHY-RAZZOUK, PU-PH, Assistance Publique - Hôpitaux de Paris

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 gennaio 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

24 giugno 2025

Primo inviato che soddisfa i criteri di controllo qualità

11 agosto 2026

Primo Inserito (Effettivo)

17 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • APHP211551
  • IDRCB: 2024-A02069-38 (Altro identificatore: ANSM)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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