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Search / Trial NCT07116811

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

Launched by BEIJING TIANTAN HOSPITAL · Aug 7, 2025

Trial Information

Current as of August 21, 2025

Not yet recruiting

Keywords

Steroids Facial Nerve Function Intraoperative Neurophysiological Monitoring Randomized Controlled Trial Facial Palsy

ClinConnect Summary

This clinical trial is studying whether giving steroids after surgery can help protect the facial nerve in people who have a vestibular schwannoma, which is a non-cancerous tumor near the ear. The facial nerve controls movements in the face, so the goal is to see if steroids can help keep facial movement normal after surgery to remove the tumor. The study will compare patients who receive steroids with those who receive a placebo (a treatment with no active medicine) to see which group has better facial nerve function after surgery.

To join this study, participants need to be between 18 and 60 years old and have a single vestibular schwannoma that has not been treated before. They must have normal facial movement before surgery and good facial nerve function during the operation, confirmed by special monitoring tests. People who need steroids for other reasons, have certain medical conditions, or are pregnant cannot join. Participants will undergo surgery as usual, and then receive either steroids or placebo to see how their facial nerve recovers. This study is not yet recruiting but aims to find better ways to protect facial movement after tumor surgery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age between 18 and 60 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

About Beijing Tiantan Hospital

Beijing Tiantan Hospital, affiliated with Capital Medical University, is a leading medical institution in China renowned for its expertise in neurology, neurosurgery, and various other specialties. As a prominent clinical trial sponsor, the hospital is committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on high-quality clinical trials, Beijing Tiantan Hospital adheres to rigorous ethical standards and regulatory requirements, fostering collaboration with academic institutions and industry partners to facilitate the development of cutting-edge therapies and interventions. Its state-of-the-art facilities and experienced research team enable the hospital to play a pivotal role in the global medical research landscape.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported