Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults

Recruiting now

Conditions studied: Bell Palsy

In brief

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

Key facts

Study ID

NCT05582915

Run by

University Hospital, Montpellier

People needed

130

Starts

2023-01-03

Expected to finish

2026-07-01

Last updated by the study team

2024-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe Bell's palsy (House-Brackmann more or equal to IV)
• Disease developed between 5 and 15 days before V0 (after initial corticotherapy)
• 18 years and older

You may not qualify if…

• Facial palsy (central or peripheral) of a following cause suspected at V0:
• Diabetes, syphilis, HIV-1 or HIV-2 infection, Lyme disease, herpes zoster infection of the geniculate ganglion; Inflammatory or immune pathology, acute or chronic; Intracranial, parotid or facial nerve tumor; Craniofacial injury; Other peripheral neuropathy
• Anti-inflammatoty, immunomodulating, immunosuppressive treatment
• Contraindications for an MRI scan
• Contraindications for a standard medical treatment: prednisone 1 mg per kg a day during 5 days and valaciclovir 3 g a day during 7 days
• Contraindications for or an impossibility of facial physiotheraphy (2 times per week along with everyday self-theraphy)
• Pregnancy or breastfeeding
• Participation to another interventional study
• Patient unaffiliated to French Social Security regime
• Patients' refusal to consent to participation in the study
• Person prived of liberty by judicial or administrative decision
• Person protected by law (under guardianship or curatorship)
• Person not able to understand the nature, the aim and the methodology of the study

Where it is running

• CHU Montpellier — Montpellier, France (enrolling)

Full record on ClinicalTrials.gov

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