Home-Based Neuromodulation in Major Depressive Disorder: Proliv™Rx Pivotal Study Findings

Background: TMS for Major Depressive Disorder (MDD) is typically restricted to the clinical setting and thus poses a substantial accessibility barrier for many patients.ProlivRx, a novel neuromodulation system employing external combined occipital and trigeminal afferent stimulation (eCOT-AS), may address this challenge by delivering physician-supervised therapy in the patient's home.Methods: This randomized, double-blind, multicenter, shamcontrolled trial assessed the safety and efficacy of ProlivRx in adults with MDD (HDRS21 20) who didn't adequately respond to antidepressants.Participants were randomized to receive either active ProlivRx therapy or sham stimulation for 8 weeks, followed by an 8-week open-label active therapy phase.Results: The modified, intent to treat analysis included 97 of 124 enrolled participants.Mean Baseline HDRS17 scores for both groups was 22.At 8 weeks, active therapy demonstrated an HDRS17 reduction of 8.6 points compared to 6 points in the sham group (p = 0.02).Remission rates were notably higher in the active therapy group (21.3% vs. 6%), as were clinically meaningful improvement rates (62% vs. 32%).By the end of the 8-week, open-label phase, both groups exhibited further improvement, achieving remission rates of 32% in the continued-active group and 22% in the initially sham group.Patient adherence to treatment was excellent, as was blinding (90% of participants unable to guess their group assignment), and no serious unanticipated adverse events were reported.Discussion: ProlivRx therapy demonstrated robust efficacy and safety in treating patients with treatment-resistant MDD.This study highlights the potential to transition neuromodulation therapy from clinical settings to the home, under physician supervision.