An observational study in Bell Palsy, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by University Hospital, Montpellier · Observational
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
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. The recovery of Bell's palsy is currently evaluated either by Sunnybrook Facial Grading System, House-Brackmann scale or Chevalier's method. It is nonetheless unpredictable, especially at the early stage of the disease.
If the first-line treatment fails to provide a fast recovery, facial nerve decompression surgery may be proposed. Being rather complex and risky, this technique shows a lower efficiency if delayed from the onset. Surgical indication is based upon clinical and radiological criteria as well as electrophysiological measurements (electromyography - EMG and electromyoneurography - EMNG). EMG and ENMG methods have a somewhat limited predictive value, since 20 to 40% patients with severe Bell's palsy can recover without surgical treatment. Moreover, these measurements are not widely accessible and, in severe cases, they should be performed between 9 and 20 days from the onset. The surgery, in order to increase its success rate, should be performed in maximum 30 days, ideally in 14 days from the onset.
Therefore, diagnostic and treatment of severe Bell's palsy face a double challenge: a narrow time window to provide a diagnostic and therapeutic strategy, and the need of a reliable prognostic methods to exclude the possibility of spontaneous recovery and thus to justify the surgical approach.
Mass Spectrometry assay allows simultaneous detection of numerous proteins, to screen for inflammatory and neurodegenerative biomarkers at acute stage of Bell's palsy. Some of these proteins might appear of a prognostic value and will help to develop more reliable and personalised treatment approach of severe Bell's palsy.
The primary objective of the study is to identify prognostic blood biomarkers related to the facial motricity recovery at 3 months from onset of severe Bell's palsy in adults.
The secondary objectives are identification of the biomarkers related to the recovery speed in the first three months, and to the initial severity of Bell's palsy; evaluation of diagnostic performance of selected biomarkers; creation of a blood collection for further research on selected biomarkers.
130 patients referred by accident and emergency department will be enrolled during their appointments at the ENT Department of the University Hospital of Montpellier. BIOFIPS study implies 4 visits, with the overall duration of 3 months per patient. After patient information and consent, routine clinical examination, audiometric testing, tympanometry, acoustic reflex testing and Bell's palsy scoring will be performed. Patients will receive a medical prescription for a blood test an MRI to exclude other causes of facial palsy. At time of inclusion and 1 month after, they will be proposed to have a blood sampling for proteomic analysis. 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.
85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.
This study's planned enrollment of 130 is above the median of 80 across 13 observational studies indexed under Bell Palsy.
Browse Bell Palsy studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults recently diagnosed with severe Bell's palsy and referred to the ENT department by A\&E or general practitionner.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diabetes, syphilis, -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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
4 ml of blood will be collected into EDTA tube for proteomic analysis at visit 0 and visit 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)
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
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
Diagnostic value of selected biomarkers
specificity, positive and negative predictive value
Time frame: Visit 0, Visit 1, Visit 2 and Visit 3
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier →