Steroids to protect facial nerve function after skull-base surgery for vestibular schwannoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind study evaluates the safety and effectiveness of perioperative steroids versus placebo in patients undergoing surgical resection of untreated unilateral vestibular schwannoma with good intraoperative facial nerve function. Eligible adults (18-70) with no preexisting facial weakness and adequate nerve preservation by monitoring are randomized to receive intravenous methylprednisolone followed by prednisone versus placebo for a short postoperative course. The primary goal is to determine if steroids improve facial nerve outcomes without unacceptable safety risks. The trial is conducted at Beijing Tiantan Hospital and uses standardized intraoperative neurophysiological criteria to define preserved nerve function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18 and 70 years
2. Diagnosed with untreated unilateral vestibular schwannoma
3. No facial palsy before surgery (House-Brackmann grade I)
4. 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
5. Signed informed consent

Exclusion Criteria:

1. Contraindications for craniotomy
2. Patients requiring corticosteroids during the perioperative period, or with known corticosteroid contraindications
3. Patients or first-degree relatives with a confirmed diagnosis of neurofibromatosis type 2 (NF2)
4. Karnofsky Performance Status (KPS) score \<90 before disease onset
5. Pregnant or planning to become pregnant during the study period
6. Participation in other interventional clinical trials
7. Judged unsuitable by the investigators

Where it's running

• Beijing Tiantan Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Wang Jia, PhD
• Email: jwttyy@126.com
• Phone: 8615510033866

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.