Not Yet RecruitingPhase 3

Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients

China364 participantsStarted 2025-09-01

Plain-language summary

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.

Who can participate

Age range18 Years – 60 Years

SexALL

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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

What they're measuring

Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery

Timeframe: at 90 (±7) days after surgery

Trial details

NCT IDNCT07116811

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Wang Jia, PhD

8615510033866 jwttyy@126.com

View on ClinicalTrials.gov More Vestibular Schwannoma trials