Identifying blood biomarkers for predicting recovery in severe Bell's palsy
Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults Using Proteomic Analysis by Quantitative Mass Spectroscopy
This study is trying to find blood markers that can help predict how well adults with severe Bell's palsy will recover.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05582915 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify prognostic blood biomarkers that can predict recovery patterns in adults suffering from severe Bell's palsy. The research focuses on patients with a House-Brackmann score of IV or higher, who have developed the condition within 5 to 15 days prior to enrollment. By analyzing blood samples, the study seeks to improve the understanding of recovery outcomes and potentially guide treatment decisions, such as the need for surgical intervention. The study is conducted at the University Hospital in Montpellier.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with severe Bell's palsy diagnosed within 5 to 15 days.
Not a fit: Patients with facial palsy due to other underlying conditions or those contraindicated for standard treatments will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction of recovery outcomes for patients with severe Bell's palsy, potentially reducing unnecessary surgical interventions.
How similar studies have performed: While there have been studies on Bell's palsy, the specific approach of identifying blood biomarkers for prognostic purposes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montpellier
- CHU Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Anne-Lise Fourez, MD
- Email: al-fourez@chu-montpellier.fr
- Phone: +334 67 33 68 90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.