Comparison of Naturalistic Treatment Outcomes with the Standard 38-Minute Protocol vs. Shortened (“Dash”) Protocol: A NeuroStar® Registry Database Study

Abstract

Background: Optimized Transcranial magnetic stimulation (TMS) protocols for major depressive disorder (MDD) are needed to improve patient convenience and access. The FDA-approved NeuroStar protocol initially required 38 minutes per session (based on 4-second trains and 26-second inter-train-intervals (ITIs)). In 2017, a new (“Dash”) protocol with shorter (11- to 25-second) ITIs was approved, reducing total session times to as short as 19 minutes. We compared naturalistic treatment outcomes for Standard and Shortened “Dash” TMS protocols. Methods: NeuroStar registry data from 103 practice sites represent 7,759 patients. N=5,010 selected for this analysis (intent-to-treat (ITT) sample) had primary MDD diagnoses, age ≥18, baseline PHQ-9 ≥10, and at least one PHQ-9 assessment after treatments began. N=613 received Standard protocol TMS and n=1,493 were treated with Dash. “Completers” (N=3,814) were those who received ≥20 sessions and had a PHQ-9 at end of their acute course. Results: Overall response rate was 57.7% (65.0% for completers) and remission (PHQ-9<5) rate 27.9% (31.7% for completers). No difference was detected between Standard and Dash protocols in longitudinal, mixed-model analyses of PHQ-9 scores. Logistic regression models with/without covariates (e.g., age, motor threshold) did not reveal an effect of protocol on response or remission. PHQ-9 improvement and number of treatments administered were equivalent for both protocols. Conclusions: These large TMS registry outcomes are consistent with other naturalistic data. No efficacy differences were found between Standard and Dash protocols, providing support for use of the quicker protocol in standard clinical practice. Limitations include lack of randomized assignment to protocol group. This study was supported by Neuronetics Inc.