An interventional study of Performing an MRI in Obstetric Brachial Plexus Palsy, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 14 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
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.
147 studies on the registry are indexed under Paralysis; 40 are open to participants now.
This study's planned enrollment of 8 is below the median of 18 across 113 interventional studies indexed under Paralysis.
Browse Paralysis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: 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.
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Extraction of diffusion tensor parameters (measurement of signal anisotropy ) along the different nerves constituting the brachial plexus, reconstructed using tractography.
Time frame: 3 months max.
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Extraction of diffusion tensor parameters, measurement of diffusivity, along the different nerves constituting the brachial plexus, reconstructed using tractography
Time frame: 3 months max.
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
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.
Time frame: 3 months max.
Characterization of the microstructure by MRI diffusion in patients with a history of unoperated obstetrical brachial plexus palsy (OBBP)
Description of FA, MD parameter measurements on tractography sequences along the complete pathway of the brachial plexus nerves
Time frame: 3 months max.
Determination of the anatomical location of POPB lesions (trunk, terminal branches, etc.) in comparison with the contralateral healthy side of the patients
Compare by MRI diffusion anatomical and diffusion measurements between different subjects
Time frame: 3 months max.
Analyze the plexus fibers altered by the neuroma in the affected plexuses
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)
Time frame: 3 months max.
Analyze the plexus fibers altered by the neuroma in the affected plexuses
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)
Time frame: 3 months max.
Establish anatomoclinical relationships with the data from the specific and in-depth clinical examination carried out in consultation
Analysis of the apparent lesions visible on MRI
Time frame: 3 months max.
Analyze the feasibility of the DTI MRI acquisition protocol
Feasibility : acquisition time (the acquisition time required to obtain image quality sufficient for post-MRI analysis),
Time frame: 3 months max.
Analyze the feasibility of the DTI MRI acquisition protocol
Feasibility: imaging quality
Time frame: 3 months max.
Plan to share: No
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Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.
Of 48 non-industry interventional studies with no phase under Paralysis, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 133. This study's planned 12 months is below that.
Counting every sponsor, half of 58 studies reached it within 41 months; a quarter within 12 and three quarters within 133.
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