A Retrospective Study to Evaluate NeuroStar® Advanced Therapy in Adolescents

A Retrospective Registry Study to Evaluate Application of NeuroStar® Advanced Therapy for Depression and Comorbid Anxiety in Adolescents

To assess the real-world effectiveness of transcranial magnetic stimulation (TMS) for depression in large adolescent and young adult samples.

Study Overview

• Status: Completed
• Conditions: MDD
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation

Detailed Description

This is a retrospective analysis. The purpose of this study is to collate real world data (RWD) from existing medical records of patients aged 12 to 21 years who received treatment with NeuroStar Advanced Therapy for Major Depressive Disorder (MDD) as determined by scores on the PHQ-9 and CGI-S assessment tool into a central registry database.

• Study Type: Observational
• Enrollment (Actual): 7690

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Malvern, Pennsylvania, United States, 19355
      • Neuronetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients between the age of 12-21 who were treated with NeuroStar Advanced Therapy for MDD on or after November 1, 2008 and the data was collected in TrakStar Database as standard of care practice

Description

Inclusion Criteria:

1. Primary diagnosis of Major Depressive Disorder (MDD), according to DSM-4/ICD-9 or DSM-5/ICD-10 criteria applicable on the date treatment with NeuroStar Advanced Therapy begins.
2. 12 to 21 years of age.
3. Male or female.
4. Treatment with NeuroStar Advanced Therapy.
5. Treatment start-date of November 1, 2008, or later.
6. Treatment end date on or before the date on which the retrospective study sample is extracted from the TrakStar database.

7. a) Per Protocol Subjects: Subject received a course of a minimum of 20 treatments with NeuroStar Advanced Therapy.

   b) Intent-to-Treat (ITT) Subjects: Subject received at least one treatment with NeuroStar Advanced Therapy.

8. Treatment with NeuroStar Advanced Therapy to the left dorsolateral prefrontal cortex (DLPFC) only.
9. Treatment with NeuroStar Advanced Therapy according to standardized NeuroStar Advanced Therapy treatment protocols of DASH and/or Standard per the current FDA clearance.
10. Each of GAD-7 and PHQ-9 scores available at each of pre-treatment (defined as the closest score available within 7 days prior to administration of the first treatment) and post-treatment (defined as the closest score available within ± 7 days of the date of the last treatment) evaluations for the single NeuroStar Advanced Therapy course.
11. Subjects with moderate or greater depression prior to NeuroStar Advanced Therapy (pre-treatment), defined as a score on the Physician Health Questionnaire-9 (PHQ-9) ≥ 10 within 7 days prior to the first treatment.

Exclusion Criteria:

- 1. Gap in NeuroStar Advanced Therapy treatment > 14 continuous days, where applicable.

2. More than one DLPFC treatment session on the same day.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescent Cohort; Patients in TrakStar database between the age of 12-21 who received at least one TMS treatment.	Device: Transcranial Magnetic Stimulation; Patients between the age of 12-21 received TMS treatment for MDD disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Outcome	To assess the pre-treatment to post-treatment change in PHQ-9 scores for the adolescent patient population. PHQ-9 is the Patient Health Questionnaire is a 9-question patient-completed assessment. Total scores range from 0 to 27. Higher the score means higher the depression severity.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Outcome	To assess the pre-treatment to post-treatment change in CGI-S scores for the adolescent patient population. The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. The total score range from 1 to 7 where 1 is normal and 7 is extremely ill patient.	8 weeks

Collaborators and Investigators

• Sponsor: Neuronetics
• Investigators: Study Director: Eleanor Cole, PhD, Neuronetics

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20226718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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