Digital vertigo therapy: efficacy results of the confirmatory randomized controlled multicenter GEVE II trial

Abstract Vertigo is one of the most common clinical complaints that severely impairs quality of life, but no evidence-based causal drug therapy is available for chronic peripheral vertigo. The recently developed non-invasive, training-based, sensorimotor and optokinetic brain stimulation program VH90D (Vertidisan®) is a CE-marked digital therapeutic that induces central vestibular compensation. We treated 259 patients with peripheral vertigo in a randomized, controlled, single blinded, confirmatory, multicenter clinical trial. VH90D reduced the Vertigo Symptom Score an average 65.36% (p < 0.0001), compared with a reduction of 22.91% in the physiotherapy control group. The confirmatory group comparison showed a highly significant treatment effect (least squares mean [LSMean] difference: − 6.3; p < 0.0001; Cohen's d = 1.1). The Dizziness Handicap Inventory also significantly improved in the VH90D group (39.99% vs. 18.11% in the control group; p < 0.0001; Cohen’s d = 0.87). The results demonstrate a significant clinical benefit of VH90D for patients with peripheral vestibular vertigo. Study registration: WHO International Clinical Trials Registry Platform (ICTRP), DRKS00028026