About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Adults recently diagnosed with severe Bell's palsy and referred to the ENT department by A\&E or general practitionner.
Trial design
Other
Prospective
Treatments tested in this trial
Blood sampling
Diagnostic test4 ml of blood will be collected into EDTA tube for proteomic analysis at visit 0 and visit 1
Treatment groups
Trial outcomes
Primary outcomes
Area under the ROC curve of biomarkers (from initial sampling) for prognosis of facial motricity recovery at 3 months
"no recovery" group: gain (Visit 3-Visit 0) \<40% on Chevalier score vs. "recovery" group: gain (Visit 3-Visit 0) ≥40% on Chevalier score. Chevalier score is a clinical scale that evaluates the percentage of facial motricity regarding 15 facial muscles.
Secondary outcomes
Biomarkers related to the speed of recovery in the first 3 months
Biomarkers (value or kinetic between Visit 0 and Visit 1 samples) related to the speed of recovery in the first 3 months: no recovery vs. recovery of PFPI
Biomarkers related to the initial severity of Bell's palsy
Biomarkers at Visit 0 related to the initial severity of Bell's palsy (House and Brackmann score): HB IV vs. IPF HB V vs. IPF HB VI
Diagnostic value of selected biomarkers
specificity, positive and negative predictive value
Sponsors and contacts
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