Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Steroids therapy, Placebo.
- Who it may be relevant to
- Registry conditions: Vestibular Schwannoma, Facial Nerve Paralysis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Steroids Treatment for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients (SAF-NRVS): a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial
Overview
The purpose of this study is to evaluate the efficacy and safety of steroids treatment compared with placebo in preserving facial nerve function after craniotomy in patients with vestibular schwannoma who have not received preoperative treatment and have good intraoperative facial nerve function.
Detailed description
Vestibular schwannoma (VS) is a benign tumor arising from the vestibular nerve. Surgical resection is a common treatment, and intraoperative neurophysiological monitoring (IONM) is widely used to protect facial nerve function. However, postoperative facial nerve paralysis remains a common complication, affecting patients' appearance, confidence, and quality of life.
Steroids are often used to reduce inflammation and edema in idiopathic facial palsy, but their efficacy and safety in post-surgical VS patients remain uncertain. The mechanism of post-surgical facial nerve dysfunction is more complex than idiopathic palsy and may involve physical traction, vascular compromise, or inflammatory injury.
This study (SAF-NRVS) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Patients aged 18 to 60 years with a clinically confirmed untreated unilateral vestibular schwannoma will be enrolled. Eligible patients must have no preoperative facial paralysis (grade I according to the House-Brackmann grading system), and have good intraoperative facial nerve function as determined by intraoperative neurophysiological monitoring. Participants will be randomly divided into two groups in a 1:1 ratio. Intervention group (Steroids group) will receive 80 mg of methylprednisolone sodium succinate powder dissolved in 100 ml of sodium chloride (NaCl) solution by intravenous infusion once daily from the day of surgery to day 3, followed by 20 mg of prednisone acetate oral intake once daily from day 4 to day 10. Control group (Placebo group) will receive methylprednisolone sodium succinate placebo powder dissolved in 100 ml of NaCl solution by intravenous infusion once daily from the day of surgery to day 3, followed by prednisone acetate placebo oral intake once daily from day 4 to day 10. The primary outcome measure is the proportion of patients with good facial nerve function recovery at 90 days after surgery, defined as grade 1 or 2 according to House-Brackmann grading system.
Interventions
- Drug Steroids therapy
Methylprednisolone sodium succinate 80 mg powder dissolved in 100 mL of sodium chloride solution (intravenous infusion, once daily) from the day of surgery to day 3, followed by 20 mg of prednisone acetate (oral intake, once daily) from day 4 to day 10. - Drug Placebo
Methylprednisolone sodium succinate placebo powder dissolved in 100 mL of sodium chloride solution (intravenous infusion, once daily) from the day of surgery to day 3, followed by prednisone acetate placebo (oral intake, once daily) from day 4 to day 10.
Primary outcome measures
- Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery [Time frame: at 90 (±7) days after surgery]
Secondary outcome measures (9)
- Good facial nerve function (House-Brackmann grade I or II) at 10 days after surgery [Time frame: at 10 days after surgery]
- Complete facial nerve function recovery (House-Brackmann grade I) at 90 days after surgery [Time frame: at 90 (±7) days after surgery]
- Complete facial nerve function recovery (House-Brackmann grade I) at 10 days after surgery [Time frame: at 10 days after surgery]
- Complete facial nerve function recovery (Sunnybrook scale 100 score) at 90 days after surgery [Time frame: at 90 (±7) days after surgery]
- Complete facial nerve function recovery (Sunnybrook scale 100 score) at 10 days after surgery [Time frame: at 10 days after surgery]
- Adverse events within 90 days [Time frame: Within 90 (±7) days after surgery]
- Serious adverse events within 90 days [Time frame: Within 90 (±7) days after surgery]
- Adverse events within 10 days [Time frame: Within 10 days after surgery]
- Serious adverse events within 10 days [Time frame: Within 10 days after surgery]
Eligibility criteria
Inclusion criteria
- Age between 18 and 60 years
- Diagnosed with untreated unilateral vestibular schwannoma
- No facial palsy before surgery (House-Brackmann grade I)
- Intraoperative neurophysiological monitoring confirms good facial nerve function preservation, defined as: a）Post-tumor resection, evoked compound muscle action potential amplitude >420 μV under 0.05 mA stimulation；and b）The amplitude is >60% of baseline value measured before dural opening
- Signed informed consent
Exclusion criteria
- Contraindications for craniotomy
- Patients requiring corticosteroids during the perioperative period, or with known corticosteroid contraindications
- Patients or first-degree relatives with a confirmed diagnosis of neurofibromatosis type 2 (NF2)
- Karnofsky Performance Status (KPS) score <90 before disease onset
- Pregnant or planning to become pregnant during the study period
- Participation in other interventional clinical trials
- Judged unsuitable by the investigators
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tiantan Hospital — Beijing
Identifiers
NCT: NCT07116811 · KY2025-137-02