Using nimodipine to protect nerves during vestibular schwannoma surgery
Intraoperative Application of Nimodipine to the Facial and Cochlear Nerves During Vestibular Schwannoma Resection to Avoid Spasm-related Postoperative Facial Paralysis and Deafness - a Prospective Randomized Pilot Study
This study is testing if using nimodipine during surgery for vestibular schwannomas can help protect the facial and hearing nerves to reduce the chances of paralysis and hearing loss afterward.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT04801953 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of nimodipine, a medication known for its neuroprotective properties, when applied directly to the facial and cochlear nerves during the surgical removal of vestibular schwannomas. It is a prospective, randomized, placebo-controlled, double-blinded trial aimed at determining whether nimodipine can reduce the risk of postoperative facial paralysis and hearing loss. Participants will be randomly assigned to receive either nimodipine or a placebo during their surgery, with outcomes assessed postoperatively.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with vestibular schwannomas measuring between 10 and 25 mm in diameter.
Not a fit: Patients with vestibular schwannomas smaller than 10 mm or larger than 25 mm, or those with contraindications for nimodipine, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of facial paralysis and deafness in patients undergoing vestibular schwannoma resection.
How similar studies have performed: Previous studies have suggested positive effects of nimodipine on nerve function preservation, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18a * Vestibular schwannoma with maximum diameter of 10-25mm on MRI * Pre-operative audiogram * Informed consent Exclusion Criteria: * Contraindication for nimodipine application * Vestibularis schwannoma diameter \<10mm or \>25mm on MRI
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Dorian Hirschmann, MD — University Clinic of Neurosurgery
- Study coordinator: Dorian Hirschmann, Dr
- Email: dorian.hirschmann@meduniwien.ac.at
- Phone: +434040025780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.