Obstetric Brachial Plexus PalsyIRM-POPBNCT07767708
Development of Diffusion MRI and Tractography Technique for the Detection of Nerve Lesions in Brachial Plexus Injuries
A study testing Performing an MRI in people with Obstetric Brachial Plexus Palsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Obstetric Brachial Plexus Palsy
- What is being tested?
- Performing an MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2026to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Orthopédique et Réparatrice de l'Enfant, Hôpital Armand Trousseau AP-HP
Paris, 75012
Manon BACCHY-RAZZOUK, PU-PH, 00 33 1 44 73 69 37, manon.bachy@aphp.fr
Mathilde PAYEN, CCA, mathilde-payen@hotmail.fr
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Obstetric Brachial Plexus Palsy
- Being tested
- Performing an MRI
- Keywords
- obstetric brachial plexus paralysis, magnetic resonance imaging, diffusion tensor imaging, tractography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing an MRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| One group | Other | Not described Receives: Other: Performing an MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 3 months max.
Secondary outcomes (6)
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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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),
Measured: 3 months max.
Analyze the feasibility of the DTI MRI acquisition protocol
Feasibility: imaging quality
Measured: 3 months max.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start9 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Brachial Plexus PalsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manon BACHY-RAZZOUK, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767708
- Sponsor's protocol ID
- APHP211551
- Other IDs
- IDRCB: 2024-A02069-38
- Acronym
- IRM-POPB
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No