Prophylactic nimodipine treatment for hearing preservation after surgery of medium to large sized vestibular schwannomas: a randomized multi-centre phase III trial

• Applicant: Professor Dr. Christian Scheller
• Subject Area: Clinical Neurology; Neurosurgery and Neuroradiology
• Term: since 2019
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 389145064

Vestibular schwannomas (VS), also known as acoustic neuromas, comprise 6-8% of all intracranial tumors with a incidence of 1-2 per 100.000. Deterioration of cochlear nerve functions is a common complication following VS surgery. Except for dexamethasone there is a lack of neuroprotective medication in neurosurgical interventions. Several retro- and prospective clinical trials point to a beneficial effect of nimodipine – a well-tolerated calcium antagonist indicated in patients with aneurysmal subarachnoid hemorrhage – on outcome of cranial nerve functions following surgery. In Germany, nimodipine is widely used in VS surgery (off-label use), however, sufficient significant evidence by randomized controlled trials of a clear neuroprotective efficacy is still missing. This randomized, two-armed, multicentric phase III trial investigates the efficacy and safety of prophylactic nimodipine for hearing preservation in VS surgery. Adults with the indication for microsurgical removal of VS are assigned to either therapy or control group. Patients of the interventional group are treated with intravenous nimodipine from the day before surgery until the fifth postoperative day additionally to standard care, the control group will get standard care alone. Hearing function will be determined by pre- and postoperative audiometry with speech discrimination and brainstem auditory evoked potentials, which will be evaluated by a blinded expert reviewer. Furthermore patient-reported outcomes using standardized questionnaires will be analysed.

• DFG Programme: Clinical Trials