Actively Recruiting
Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults Using Proteomic Analysis by Quantitative Mass Spectroscopy
Led by University Hospital, Montpellier · Updated on 2024-08-20
130
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Bell's palsy is a common cause of facial paralysis caused by inflammation of the facial nerve, possibly due to herpesvirus reactivation. This condition is usually treated with corticosteroids, antiviral drugs, and physiotherapy. Severe cases can lead to lasting facial movement problems or spasms that greatly impact quality of life. This study aims to find blood biomarkers that can predict how well adults with severe Bell's palsy will recover, helping to guide treatment decisions such as surgery. The study involves collecting blood samples from adult patients with severe Bell's palsy at two time points early in their illness. These samples will be analyzed using mass spectrometry to measure 125 different proteins that may relate to inflammation or nerve damage. The study will track the patients' facial movement recovery over three months, aiming to identify biomarkers linked to recovery patterns and severity. Routine clinical exams, hearing tests, MRI scans, and facial grading will also be part of the study visits. Participants will attend four visits over three months, beginning with clinical assessments and blood sampling. They will be monitored for facial movement recovery using established grading scales. Researchers will analyze the blood biomarkers to see how well they predict recovery at three months. Safety and treatment response will be followed, and the study will create a blood sample collection for future research. The total participation time for each patient is approximately three months.
CONDITIONS
Brief Title
Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe Bell's palsy with House-Brackmann grade IV or higher
- Disease onset between 5 and 15 days before the first visit, after initial corticosteroid treatment
- Adults aged 18 years and older
You will not qualify if you...
- Facial palsy caused by conditions such as diabetes, syphilis, HIV-1 or HIV-2 infection, Lyme disease, herpes zoster infection of the geniculate ganglion, inflammatory or immune diseases, tumors, craniofacial injury, or other peripheral neuropathies
- Current treatment with anti-inflammatory, immunomodulating, or immunosuppressive drugs
- Contraindications for MRI scans
- Contraindications for standard medical treatment with prednisone and valaciclovir
- Contraindications or inability to undergo facial physiotherapy twice a week plus daily self-therapy
- Pregnancy or breastfeeding
- Participation in another interventional study
- Not affiliated with the French Social Security system
- Refusal to consent to study participation
- Legal restrictions such as judicial or administrative detention
- Legal protections such as guardianship or curatorship
- Inability to understand the study's nature, purpose, and methods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial visit and up to 1 month
Participants undergo routine clinical examination, audiometric testing, tympanometry, acoustic reflex testing, Bell's palsy scoring, blood test, and MRI to exclude other causes of facial palsy.
4 visits over 3 months
Duration - 3 months
Participants have blood sampling for proteomic analysis at inclusion and 1 month later to identify prognostic biomarkers related to facial motricity recovery.
4 visits over 3 months
Trial Site Locations
Total: 1 location
1
CHU Montpellier
Montpellier, France
Actively Recruiting
Research Team
A
Anne-Lise Fourez, MD
F
Frédéric Venail, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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