Retrospective Analyses of TrakStar Database

April 6, 2026 updated by: Neuronetics

Retrospective Analyses Evaluating the Real-World Effectiveness of NeuroStar® TMS and the Factors Associated With Clinical Outcomes

In this study, real-world data will be used to better understand the effects patient characteristics, symptoms and TMS protocol parameters have on clinical outcomes with NeuroStar TMS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

156000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Malvern, Pennsylvania, United States, 19355
        • Recruiting
        • Neuronetics
        • Contact:
          • Eleanor Cole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients treated with NeuroStar Advanced TMS Therapy on or after November 1, 2008, and whose treatment information was entered in the Neuronetics TrakStar database.

Description

Inclusion Criteria:

  • Male or female reported in database and not an invalid entry
  • Age reported and not an invalid entry
  • Treatment date of November 01, 2008 or later.

Exclusion Criteria:

• Incomplete information on treatment parameters

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with NeuroStar TMS
Device: NeuroStar Advanced TMS Therapy System
non-invasive brain stimulation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical assessment score from baseline to post-treatment
Time Frame: 8 weeks
real-world efficacy of NeuroStar TMS in reducing patients' symptoms, reduction in clinical assessment score like PHQ-9
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age at baseline and its correlation to change in score post treatment
Time Frame: 8 weeks
Determine the patient characteristics like age that are associated with clinical outcomes- PHQ-9 following NeuroStar TMS
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuronetics

Investigators

  • Study Director: Eleanor Cole, PhD, Neuronetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-10000-000

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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