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

NCT05582915 | Recruiting

• 1 other identifier: RECHMPL22_0036
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Bell Palsy

Keywords

Bell's palsy; Proteomics; Biomarkers; Mass spectroscopy; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Biomarkers related to the speed of recovery in the first 3 months

  Visit 0, Visit 1, Visit 2 and Visit 3

• Biomarkers related to the initial severity of Bell's palsy

  Visit 0

• Diagnostic value of selected biomarkers

  Visit 0, Visit 1, Visit 2 and Visit 3

Study Arms (1)

Adult patients with severe Bell's palsy

Adult patients recently diagnosed with severe Bell's palsy and referred to the ENT Department by A\&E or by general practitionner.

Diagnostic Test: Blood sampling

Interventions

Blood sampling DIAGNOSTIC_TEST

4 ml of blood will be collected into EDTA tube for proteomic analysis at visit 0 and visit 1

Adult patients with severe Bell's palsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults recently diagnosed with severe Bell's palsy and referred to the ENT department by A\&E or general practitionner.

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)
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma collection for proteomic analysis (after veinous blood centrifugation)

MeSH Terms

Conditions

Bell Palsy

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Anne-Lise Fourez, MD

CONTACT

+334 67 33 68 90; al-fourez@chu-montpellier.fr

Frédéric Venail, MD, PhD

CONTACT

+334 67 33 68 90; f-venail@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 17, 2022
• Study Start: January 3, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

FR (1)