Actively Recruiting
Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults
Led by University Hospital, Montpellier · Updated on 2024-08-20
130
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bell's palsy (idiopathic peripheral facial palsy) is the most common cause of facial palsy, which is related to the inflammation of the facial nerve, possibly induced by herpesvirus reactivation. Its first-line treatment comprises corticosteroids, antiviral therapy and physiotherapy. In most severe cases (grade IV to VI on House-Brackmann scale), facial motricity may remain altered or develop synkinesis or post-paralytic spasm, thus tremendously affecting quality of life. To avoid potential complications, surgical facial nerve decompression could be proposed. To date, however, there are no means to predict if Bell's palsy will evolve with any complications or if the patient will recover entirely. Thus, the invasive facial nerve decompression is equally proposed to subjects who will develop the consequences as well as to subjects able to restore without surgical treatment. This study proposes to search for prognostic blood biomarkers related to the Bell's palsy recovery pattern. Adult patients with severe Bell's palsy will be proposed to have a blood sampling for proteomic analysis in the early stage of the disease. Then 125 biomarkers on a Peptiquant™ kit will be analysed by mass spectrometry, and prognostic biomarkers will be selected regarding to the clinical recovery of Bell's palsy
CONDITIONS
Official 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 first visit after initial corticosteroid treatment
- Age 18 years or older
You will not qualify if you...
- Facial palsy caused by diabetes, syphilis, HIV-1 or HIV-2, Lyme disease, herpes zoster, inflammatory or immune diseases, tumors, craniofacial injury, or other neuropathies
- Current anti-inflammatory, immunomodulating, or immunosuppressive treatments
- Contraindications to MRI scan
- Contraindications to standard treatment with prednisone and valaciclovir
- Unable to undergo facial physiotherapy twice a week plus daily self-therapy
- Pregnancy or breastfeeding
- Participation in another interventional study
- Not affiliated with French Social Security
- Refusal to consent to the study
- Legal restrictions such as judicial detention or guardianship
- Inability to understand the nature and purpose of the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Montpellier
Montpellier, France
Actively Recruiting
Research Team
A
Anne-Lise Fourez, MD
CONTACT
F
Frédéric Venail, MD, PhD
CONTACT
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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