Development of Diffusion MRI and Tractography Technique for the Detection of Nerve Lesions in Brachial Plexus Injuries (IRM-POPB)
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Manon BACHY-RAZZOUK, PU-PH
- Telefonní číslo: 00 33 1 44 73 69 37
- E-mail: manon.bachy@aphp.fr
Studijní záloha kontaktů
- Jméno: Mathilde PAYEN, PH
- Telefonní číslo: 00 33 2 32 88 89 90
- E-mail: mathilde-payen@hotmail.fr
Studijní místa
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Paris, Francie, 75012
- Nábor
- Service de Chirurgie Orthopédique et Réparatrice de l'Enfant, Hôpital Armand Trousseau AP-HP
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Kontakt:
- Manon BACCHY-RAZZOUK, PU-PH
- Telefonní číslo: 00 33 1 44 73 69 37
- E-mail: manon.bachy@aphp.fr
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Kontakt:
- Mathilde PAYEN, CCA
- E-mail: mathilde-payen@hotmail.fr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: One group
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Časové okno: 3 months max.
|
Extraction of diffusion tensor parameters (measurement of signal anisotropy ) along the different nerves constituting the brachial plexus, reconstructed using tractography.
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3 months max.
|
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Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Časové okno: 3 months max.
|
Extraction of diffusion tensor parameters, measurement of diffusivity, along the different nerves constituting the brachial plexus, reconstructed using tractography
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3 months max.
|
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Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Časové okno: 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.
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3 months max.
|
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Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Časové okno: 3 months max.
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Description of FA, MD parameter measurements on tractography sequences along the complete pathway of the brachial plexus nerves
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3 months max.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Determination of the anatomical location of POPB lesions (trunk, terminal branches, etc.) in comparison with the contralateral healthy side of the patients
Časové okno: 3 months max.
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Compare by MRI diffusion anatomical and diffusion measurements between different subjects
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3 months max.
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Analyze the plexus fibers altered by the neuroma in the affected plexuses
Časové okno: 3 months max.
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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)
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3 months max.
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Analyze the plexus fibers altered by the neuroma in the affected plexuses
Časové okno: 3 months max.
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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)
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3 months max.
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Establish anatomoclinical relationships with the data from the specific and in-depth clinical examination carried out in consultation
Časové okno: 3 months max.
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Analysis of the apparent lesions visible on MRI
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3 months max.
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Analyze the feasibility of the DTI MRI acquisition protocol
Časové okno: 3 months max.
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Feasibility : acquisition time (the acquisition time required to obtain image quality sufficient for post-MRI analysis),
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3 months max.
|
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Analyze the feasibility of the DTI MRI acquisition protocol
Časové okno: 3 months max.
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Feasibility: imaging quality
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3 months max.
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Manon BACHY-RAZZOUK, PU-PH, Assistance Publique - Hôpitaux de Paris
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- APHP211551
- IDRCB: 2024-A02069-38 (Jiný identifikátor: ANSM)
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