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

11. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

8

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Manon BACHY-RAZZOUK, PU-PH
  • Telefonnummer: 00 33 1 44 73 69 37
  • E-post: manon.bachy@aphp.fr

Studer Kontakt Backup

Studiesteder

  • Frankrike
      • Paris, Frankrike, 75012
        • Rekruttering
        • Service de Chirurgie Orthopédique et Réparatrice de l'Enfant, Hôpital Armand Trousseau AP-HP
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: One group
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 3 months max.
Description of FA, MD parameter measurements on tractography sequences along the complete pathway of the brachial plexus nerves
3 months max.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Determination of the anatomical location of POPB lesions (trunk, terminal branches, etc.) in comparison with the contralateral healthy side of the patients
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months max.
Analysis of the apparent lesions visible on MRI
3 months max.
Analyze the feasibility of the DTI MRI acquisition protocol
Tidsramme: 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
Tidsramme: 3 months max.
Feasibility: imaging quality
3 months max.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Assistance Publique - Hôpitaux de Paris

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. januar 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

24. juni 2025

Først innsendt som oppfylte QC-kriteriene

11. august 2026

Først lagt ut (Faktiske)

17. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • APHP211551
  • IDRCB: 2024-A02069-38 (Annen identifikator: ANSM)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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