The NeuroStar Outcomes Registry

NeuroStar transcranial magnetic stimulation (TMS) is an effective acute treatment for patients with major depressive disorder (MDD). In order to further understand use of the NeuroStar in a clinical setting, Neuronetics has established a patient treatment and outcomes registry to collect and analyze utilization information on patients receiving treatment with the NeuroStar.

Individual NeuroStar providers are invited to participate in the registry and agree to provide their de-identified patient treatment data. The NeuroStar has an integrated electronic data management system (TrakStar) which allows for the data collection to be automated. The data collected for the registry include Demographic Elements (age, gender), Treatment Parameters, and Clinical Ratings. Clinical assessments are: Clinician Global Impression - Severity of Illness (CGI-S) and thePatient Health Questionnaire 9-item (PHQ-9). De-identified patient data is uploaded to Registry server; an independent statistical service then creates final data reports.

Over 500 patients have entered the NeuroStar Outcomes Registry since Sept 2016. Mean patient age: 48.0 (SD±16.0); 64% Female. Baseline PHQ-9, mean 18.8 (SD±5.0.) Response/Remission Rate, PHQ-9: 61%/33% CGI-S: 78%/59%.

For the initial 500 patients in the Outcomes Registry, approximately 2/3 patients achieve respond and 1/3 patients achieve remission with an acute course of NeuroStar. These treatment outcomes consistent with NeuroStar open-label study data (Carpenter, 2012). The TrakStar data management system makes large scale data collection feasible. The NeuroStarOutcomes Registry is ongoing, and expected to reach 6000 outpatients from more than 47 clinical sites in 36 months.

Neuronetics, Inc.