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

ConditionBell Palsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling

    Diagnostic test

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

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: Adult patients with severe Bell's palsy1 intervention

Trial outcomes

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.

Time frame
Visit 0, Visit 1, Visit 2 and Visit 3 (3 months)

Secondary outcomes

1

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

Time frame
Visit 0, Visit 1, Visit 2 and Visit 3
2

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

Time frame
Visit 0
3

Diagnostic value of selected biomarkers

specificity, positive and negative predictive value

Time frame
Visit 0, Visit 1, Visit 2 and Visit 3

Other outcomes

Sponsors and contacts

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