Bell's PalsyPhase 2/3NCT03508440
Intratympanic Steroid for Bell's Palsy
A Phase 2/3 study testing Intratympanic injection and Prednisone in people with Bell's Palsy and Facial Nerve Paresis, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Facial nerve paralysis is due to inflammation around the facial nerve. Current treatment for facial nerve paralysis is a 10 day course of oral steroids (which will reduce the inflammation), with electrodiagnostic testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bell's Palsy, Facial Nerve Paresis
- What is being tested?
- Intratympanic injection and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 1 Jun 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- English as primary language
- Acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less.
- Moderate to severe facial palsy [House-Brackmann grade IV or greater]
Who cannot join
- Another cause of facial nerve paralysis that is not idiopathic
- Otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay Hunt syndrome.
- Systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose steroid therapy.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intratympanic Steroid Injection for Treatment of Idiopathic Facial Nerve Paralysis
Facial nerve paralysis is due to inflammation around the facial nerve. Current treatment for facial nerve paralysis is a 10 day course of oral steroids (which will reduce the inflammation), with electrodiagnostic testing. There have been limited studies on the use of intratympanic steroid injection, in addition to oral steroid, in the recovery of facial nerve paralysis. There are indications that the use of intratympanic injections, in addition to the oral steroids, will speed up the recovery rate of the facial nerve paralysis, as well as improve the complete recovery of the facial nerve paralysis. This study will randomize patients with facial nerve paralysis into two groups: 1) oral steroid only and 2) oral steroid plus a 3 intratympanic steroid injections spaced out over three weeks. There are a subset of patients that are unable to take oral steroids for medical reasons (such as diabetes); these patients will be placed into a third group and only receive 3 intratympanic steroid injections space out over three weeks. Subjects that are to receive the intratympanic injection will receive pre- and post-hearing exams as part of their standard of care. Patients will be evaluated via videorecording by two blinded investigators as well as in person evaluations by the unblinded treating physician.
Subjects will be followed until complete facial nerve paralysis recovery or one year post-treatment, whichever comes first.
Read the detailed description
Facial nerve paralysis is due to inflammation surrounding the facial nerve. Current clinical practice guidelines for treatment of facial nerve paralysis recommend a 10 day course of oral steroids +/- oral acyclovir. Treatment should begin within 72 hours of symptom onset. In patients with complete facial paralysis, electrodiagnostic testing should be offered to the patient (1-2). In patients with 90% degeneration on electroneuronography (ENoG) testing, facial nerve decompression may be considered but is not a current recommendation.
In 1973, Bryant reported on ten cases where intratympanic steroid injection was used for the treatment of Bell's palsy (3). All but one of these patients had complete recovery of their facial nerve function. The remaining patient had 75% recovery. None of these patients suffered complications from the injections. The next study published on intratympanic steroid injection for Bell's palsy was not published until 2014 (4). It was a randomized control trial that divided patients into standard treatment (oral steroids and acyclovir) versus standard treatment with intratympanic steroid injection. There was not a statistically significant difference between the complete recovery rate of the control group and of the intratympanic steroid group; however, the time to recovery was significantly shorter in the intratympanic steroid injection group as compared to the control group. Limitations of this study include small sample size and high attrition rate.
There have not been any other studies published in the literature looking at improving facial nerve recovery in idiopathic facial nerve paralysis with the use of intratympanic steroid injections.
- Conditions
- Bell's Palsy, Facial Nerve Paresis
- Being tested
- Intratympanic injection, Prednisone
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intratympanic injectionProcedure or surgery
Injection will be up to 1cc of dexamethasone 24mg/mL. The procedure will be performed at supine position under a microscope. Local anesthesia will be achieved with topical phenol. A myringotomy will be made in the tympanic membrane. A 1 mL syringe connected to a needle will be used to slowly inject between 0.2 cc and 1.0 cc of solution through the myringotomy, with the subject's head turned 45 degrees to the opposite side. The subject will be asked to maintain positioning for at least 30 minutes and refrain from swallowing. The dose administered will vary due to subject-specific factors.
PrednisoneDrug
Also called Prednisolone
Oral Steroid
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Oral steroids (prednisone or prednisolone) 60mg per day for 10 days or 60mg/day for 5 days followed by a 5 day taper Receives: Drug: Prednisone |
| SOC + injection | Experimental | Oral steroids as described above + intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks. Receives: Procedure: Intratympanic injection; Drug: Prednisone |
| Injection only | Other | Only Intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks Receives: Procedure: Intratympanic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Nerve Recovery
Time (in days) from the diagnosis or start of treatment to complete recovery of paralysis, defined as house brackman score of 1
Measured: Up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start31 Jan 2018
- Primary completion22 Nov 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bell's PalsyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One arm will receive standard of care (SOC) in the form of high dose oral steroids for 10 days. The second arm will receive SOC plus 3 intratympanic steroid injections (space 7 days apart). Arm 3 is for patients who can not, for medical reasons, receive SOC; these patients will receive 3 intratympanic steroid injections (space 7 days apart).
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaldo L. Rivera, University of Missouri-Columbia
- Investigators
- Arnaldo Rivera, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508440
- Sponsor's protocol ID
- 2007139
- Status last verified
- Oct 2024
- First submitted
- 16 Apr 2018
- Last updated
- 5 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable...we do not plan to share individual participant data with other researchers so that we can maintain the privacy of our participants.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratympanic Steroid Injection for Treatment of Idiopathic Facial Nerve Paralysis
- ClinicalTrials.gov ID
- NCT03508440
- Acronym / sponsor ID
- 2007139
- Conditions
- Bell's Palsy, Facial Nerve Paresis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Facial nerve paralysis is due to inflammation around the facial nerve. Current treatment for facial nerve paralysis is a 10 day course of oral steroids (which will reduce the inflammation), with electrodiagnostic testing. There have been limited studies on the use of intratympanic steroid injection, in addition to oral steroid, in the recovery of facial nerve paralysis. There are indications that the use of intratympanic injections, in addition to the oral steroids, will speed up the recovery rate of the facial nerve paralysis, as well as improve the complete recovery of the facial nerve paralysis. This study will randomize patients with facial nerve paralysis into two groups: 1) oral steroid only and 2) oral steroid plus a 3 intratympanic steroid injections spaced out over three weeks. There are a subset of patients that are unable to take oral steroids for medical reasons (such as diabetes); these patients will be placed into a third group and only receive 3 intratympanic steroid injections space out over three weeks. Subjects that are to receive the intratympanic injection will receive pre- and post-hearing exams as part of their standard of care. Patients will be evaluated via videorecording by two blinded investigators as well as in person evaluations by the unblinded treating physician.
Subjects will be followed until complete facial nerve paralysis recovery or one year post-treatment, whichever comes first.
Detailed description
Facial nerve paralysis is due to inflammation surrounding the facial nerve. Current clinical practice guidelines for treatment of facial nerve paralysis recommend a 10 day course of oral steroids +/- oral acyclovir. Treatment should begin within 72 hours of symptom onset. In patients with complete facial paralysis, electrodiagnostic testing should be offered to the patient (1-2). In patients with 90% degeneration on electroneuronography (ENoG) testing, facial nerve decompression may be considered but is not a current recommendation.
In 1973, Bryant reported on ten cases where intratympanic steroid injection was used for the treatment of Bell's palsy (3). All but one of these patients had complete recovery of their facial nerve function. The remaining patient had 75% recovery. None of these patients suffered complications from the injections. The next study published on intratympanic steroid injection for Bell's palsy was not published until 2014 (4). It was a randomized control trial that divided patients into standard treatment (oral steroids and acyclovir) versus standard treatment with intratympanic steroid injection. There was not a statistically significant difference between the complete recovery rate of the control group and of the intratympanic steroid group; however, the time to recovery was significantly shorter in the intratympanic steroid injection group as compared to the control group. Limitations of this study include small sample size and high attrition rate.
There have not been any other studies published in the literature looking at improving facial nerve recovery in idiopathic facial nerve paralysis with the use of intratympanic steroid injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- One arm will receive standard of care (SOC) in the form of high dose oral steroids for 10 days. The second arm will receive SOC plus 3 intratympanic steroid injections (space 7 days apart). Arm 3 is for patients who can not, for medical reasons, receive SOC; these patients will receive 3 intratympanic steroid injections (space 7 days apart).
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: PrednisoneOral steroids (prednisone or prednisolone) 60mg per day for 10 days or 60mg/day for 5 days followed by a 5 day taper |
| SOC + injection | Experimental | Procedure: Intratympanic injection, Drug: PrednisoneOral steroids as described above + intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks. |
| Injection only | Other | Procedure: Intratympanic injectionOnly Intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English as primary language
- Acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less.
- Moderate to severe facial palsy [House-Brackmann grade IV or greater]
Key exclusion criteria (4 listed)
- Another cause of facial nerve paralysis that is not idiopathic
- Otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay Hunt syndrome.
- Systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose steroid therapy.
- Pregnancy
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 |
|---|---|---|
| Intratympanic injectionInjection will be up to 1cc of dexamethasone 24mg/mL. The procedure will be performed at supine position under a microscope. Local anesthesia will be achieved with topical phenol. A myringotomy will be made in the tympanic membrane. A 1 mL syringe connected to a needle will be used to slowly inject between 0.2 cc and 1.0 cc of solution through the myringotomy, with the subject's head turned 45 degrees to the opposite side. The subject will be asked to maintain positioning for at least 30 minutes and refrain from swallowing. The dose administered will vary due to subject-specific factors. | Procedure or surgery | Injection only, SOC + injection |
| PrednisoneAlso: PrednisoloneOral Steroid | Drug | SOC + injection, Standard of Care |
Primary outcome
Facial Nerve Recovery
Time frame: Up to 365 days
Time (in days) from the diagnosis or start of treatment to complete recovery of paralysis, defined as house brackman score of 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not applicable...we do not plan to share individual participant data with other researchers so that we can maintain the privacy of our participants.
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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.
Arnaldo Rivera, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intratympanic injection and Prednisone in people with Bell's Palsy and Facial Nerve Paresis, run by University of Missouri-Columbia at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 5 Nov 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Nerve Recovery (time frame: Up to 365 days). 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 5 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.