Bell PalsyBIOFIPSNCT05582915
Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults
An observational study of Bell Palsy, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Blood sampling
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2023to Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults recently diagnosed with severe Bell's palsy and referred to the ENT department by A\&E or general practitionner.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Montpellier
Montpellier
Anne-Lise Fourez
About this study
Official title: Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults Using Proteomic Analysis by Quantitative Mass Spectroscopy
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
Read the detailed description
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.
- Conditions
- Bell Palsy
- Being tested
- Blood sampling
- Keywords
- Bell's palsy, Proteomics, Biomarkers, Mass spectroscopy, Prognosis
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
4 ml of blood will be collected into EDTA tube for proteomic analysis at visit 0 and visit 1
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
Measured: Visit 0
Diagnostic value of selected biomarkers
specificity, positive and negative predictive value
Measured: Visit 0, Visit 1, Visit 2 and Visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start3 Jan 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582915
- Sponsor's protocol ID
- RECHMPL22_0036
- Acronym
- BIOFIPS
- Status last verified
- Aug 2024
- First submitted
- 5 Oct 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults Using Proteomic Analysis by Quantitative Mass Spectroscopy
- ClinicalTrials.gov ID
- NCT05582915
- Acronym / sponsor ID
- BIOFIPS / RECHMPL22_0036
- Conditions
- Bell Palsy
- Keywords
- Bell's palsy, Proteomics, Biomarkers, Mass spectroscopy, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with severe Bell's palsy | – | Diagnostic Test: Blood samplingAdult patients recently diagnosed with severe Bell's palsy and referred to the ENT Department by A\&E or by general practitionner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults recently diagnosed with severe Bell's palsy and referred to the ENT department by A\&E or general practitionner.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling4 ml of blood will be collected into EDTA tube for proteomic analysis at visit 0 and visit 1 | Diagnostic test | Adult patients with severe Bell's palsy |
Primary outcome
Area under the ROC curve of biomarkers (from initial sampling) for prognosis of facial motricity recovery at 3 months
Time frame: Visit 0, Visit 1, Visit 2 and Visit 3 (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.
3 secondary outcomes
Biomarkers related to the speed of recovery in the first 3 months
Time frame: Visit 0, Visit 1, Visit 2 and Visit 3
Biomarkers related to the initial severity of Bell's palsy
Time frame: Visit 0
Diagnostic value of selected biomarkers
Time frame: Visit 0, Visit 1, Visit 2 and Visit 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bell Palsy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Lise Fourez, MD (+334 67 33 68 90, al-fourez@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the ROC curve of biomarkers (from initial sampling) for prognosis of facial motricity recovery at 3 months (time frame: Visit 0, Visit 1, Visit 2 and Visit 3 (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.