3 results
161 The NeuroStar Outcomes Registry
- Miriam Mina, Todd Hutton, Karen Heart
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- Journal:
- CNS Spectrums / Volume 25 / Issue 2 / April 2020
- Published online by Cambridge University Press:
- 24 April 2020, p. 303
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Objective:
NeuroStar® Advanced Therapy System is an effective acute treatment for patients with major depressive disorder (MDD). To further understand the efficacy of the NeuroStar in a clinical setting, Neuronetics has established the largest patient treatment and outcomes registry for Major Depressive Disorder (MDD) to collect and analyze the efficacy of transcranial magnetic stimulation (TMS) on patients receiving NeuroStar treatment.
Methods:Individual NeuroStar providers are invited to participate in the registry and over 100 clinical practice sites have agreed to provide their de-identified patient treatment data. An integrated electronic data management system (TrakStar) allows for large-scale data collection to be automated. The data collected for the registry include Demographic Elements (age, gender), Treatment Parameters, and Clinical Ratings. Clinical assessments performed at baseline and the end of acute treatment are the Patient Health Questionnaire 9-item (PHQ-9) and the Clinician Global Impression - Severity of Illness (CGI-S). De-identified patient data is uploaded to a Registry server; an independent statistical service then creates final data reports.
Results:Over 3300 evaluable patients have entered the NeuroStar Outcomes Registry since September 2016. The population is 64% female with a mean patient age of 47.8 (SD±16.9); Mean baseline PHQ-9 is 19.0 (SD±5.0). Response & remission rate on PHQ-9 is 63% & 33%, and on CGI-S was 76% & 54%, respectively.
Conclusions:For the over 3300 patients in the Outcomes Registry, approximately 2/3 patients achieve response and 1/3 patients achieve remission with an acute course of NeuroStar TMS. These treatment outcomes are consistent with previous open-label study data (Carpenter et al., 2012) using the NeuroStar system. The NeuroStar Outcomes Registry is ongoing and has surpassed Star*D dataset (Rush et al., 2006) with over 3300 evaluable patients from more than 100 clinical sites in 3 years.
Funding Acknowledgements:Funding: Neuronetics, Inc.
160 Optimizing TMS Treatment for Depression - The 19 Minute Dash™ Protocol
- Miriam Mina, David G. Brock, Alvaro Pascual-Leone, Mark A. Demitrak
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- Journal:
- CNS Spectrums / Volume 23 / Issue 1 / February 2018
- Published online by Cambridge University Press:
- 15 June 2018, pp. 97-98
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Title
Optimizing TMS treatment for Depression - The 19 Minute Dash™ protocol
ObjectiveNeuroStar transcranial magnetic stimulation (TMS) is an effective treatment for patients with major depressive disorder. Due to the treatment session duration, a reduced treatment time would promote patients’ comfort and convenience. Also, shorter treatment sessions of retained efficacy and safety would increase access to treatment. This reduction could be accomplished by decreasing the time between TMS pulse sequences, the intertrain interval (ITI).
MethodsMeta-analysis of TMS delivered using varying treatment parameters, particularly the ratio of train duration (“on-time”) to ITI (“off-time”). PubMed and SCOPUS databases were searched through March 30, 2015 using the terms: “transcranial magnetic stimulation”, “TMS”, “rTMS”, “inter-train interval”, “inter-stimulus interval”, and “cortical spread”. Three hundred and one articles were identified comprising a total of 3359 patients. Clinical outcomes were reported as the proportion of patients achieving response defined as 50% reduction in baseline score on the primary outcome measure in each study. Treatment risk was assessed by the frequency of adverse events reported, and specifically considering the incidence of seizures.
ResultsThis analysis confirms prior reports that the variables which impact treatment efficacy are the number of treatmentsessions, the number of pulses per session and the percent motor threshold. Varying the train duration/ITI (on-time/off-time) ratio over a broad range from 2.0 to 14 did not impact efficacy or safety.
ConclusionsShortening the ITI to 11 seconds does not impact the safety and antidepressant effectiveness of the NeuroStar TMS and would result in shortening of each treatment session from approximately 37.5 to 19 minutes.
Funding AcknowledgementsNeuronetics, Inc.
161 The NeuroStar Outcomes Registry
- Miriam Mina, David G. Brock, W. Scott West, Todd Hutton, Kenneth P. Pages, Timothy J. Kane
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- Journal:
- CNS Spectrums / Volume 23 / Issue 1 / February 2018
- Published online by Cambridge University Press:
- 15 June 2018, p. 98
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- Article
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- You have access Access
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The NeuroStar Outcomes Registry
ObjectiveNeuroStar 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.
MethodsIndividual 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.
ResultsOver 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%.
ConclusionsFor 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.
Funding AcknowledgementsNeuronetics, Inc.