Abstract
BackgroundTranscranial magnetic stimulation (TMS) is an effective treatment for major depressive disorder (MDD). The rest time between pulse trains is the inter-train interval (ITI). Since 2016, some TMS clinicians have adopted a stimulation protocol with shorter ITIs than were used in regulatory clinical trials. ObjectiveTo contrast treatment outcomes with the Standard TMS protocol (38.5 min per session) and the “Dash” protocol, which, at the shortest ITI, has a session duration of 18.75 min. MethodsRegistry data were collected at 103 practice sites. Of 7759 participants, 5010 were included in an intent-to-treat (ITT) sample, defined as a primary MDD diagnosis, age ≥ 18, and completion of the PHQ-9 before TMS and with at least one PHQ-9 assessment after baseline. Completers (N = 3814) were responders or had received ≥ 20 sessions and had an end of acute treatment PHQ-9 assessment. Within the ITT sample, 613 patients were treated with the Standard NeuroStar 38-min protocol and 1493 patients with the new Dash protocol. CGI-S ratings were obtained in smaller samples. Treatment outcomes were also examined in subgroups considered Completers, as well as the subgroups who met criteria for Full Adherence to the Standard or Dash protocol parameters. ResultsIn the ITT, Completer, and Fully Adherent samples, response (58–72%) and remission (28–53%) rates were notably high across PHQ-9 and CGI-S ratings. The Standard and Dash protocols did not differ in number of treatment sessions, and both manifested strong antidepressant effects. ConclusionsThe Standard and Dash protocols did not meaningfully differ in efficacy.
Highlights
Transcranial Magnetic Stimulation (TMS) is widely regarded as an effective treatment for episodes of major depressive disorder (MDD) [1e4]
Treatment parameters were captured at each treatment session passively with the NeuroStar TMS software which was synchronized to the TrakStar® Cloud software, and included session date, treatment location of stimulation [i.e., left dorsolateral prefrontal cortex (DLPFC), right DLPFC, or both], motor threshold (MT), number of pulses per treatment location or session, TMS intensity, pulse frequency (e.g., 10 Hz vs. 1 Hz), and the number of treatment sessions during the acute phase treatment course
Clinical Global Impression e Severity scale (CGI-S) ratings were obtained in considerably fewer patients; when analyzing CGI-S data, we found larger antidepressant effects in the Dash treatment group manifested as lower final CGI-S scores
Summary
Transcranial Magnetic Stimulation (TMS) is widely regarded as an effective treatment for episodes of major depressive disorder (MDD) [1e4]. The original device “label” described a stimulation protocol targeting the left dorsolateral prefrontal cortex (DLPFC), and specified stimulation parameters that were used to establish effectiveness and safety in the pivotal regulatory clinical trials [5e7] This “default” prescription stipulated 10 Hz stimulation at 120% intensity (relative to resting motor threshold), 4 s train duration, with each train separated by a 26 s inter-train “rest” interval (ITI), and 75 pulse trains, resulting in a total of 3000 pulses per session. Those same treatment parameters were used to confirm the efficacy and safety of TMS in a subsequent NIMH-supported randomized shamcontrolled trial by George et al [8]. Conclusions: The Standard and Dash protocols did not meaningfully differ in efficacy
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