Bell Palsy Clinical Trial
— BIOFIPSOfficial title:
Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults Using Proteomic Analysis by Quantitative Mass Spectroscopy
NCT number | NCT05582915 |
Other study ID # | RECHMPL22_0036 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 3, 2023 |
Est. completion date | August 2024 |
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
Status | Recruiting |
Enrollment | 130 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Visit 0, Visit 1, Visit 2 and Visit 3 (3 months) | |
Secondary | 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 | Visit 0, Visit 1, Visit 2 and Visit 3 | |
Secondary | 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 | Visit 0 | |
Secondary | Diagnostic value of selected biomarkers | specificity, positive and negative predictive value | Visit 0, Visit 1, Visit 2 and Visit 3 |
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