Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Steroids therapy
- Placebo
Treatment groups
364 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov