NCT06917339

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156,000

participants targeted

Target at P75+ for all trials

Timeline
116mo left

Started Feb 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2025Dec 2035

Study Start

First participant enrolled

February 25, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

10.8 years

First QC Date

March 18, 2025

Last Update Submit

April 6, 2026

Conditions

DepressionObsessive-Compulsive DisorderAnxiety Depression

Keywords

TMS

Outcome Measures

Primary Outcomes (1)

  • Change in clinical assessment score from baseline to post-treatment

    real-world efficacy of NeuroStar TMS in reducing patients' symptoms, reduction in clinical assessment score like PHQ-9

    8 weeks

Secondary Outcomes (1)

  • Age at baseline and its correlation to change in score post treatment

    8 weeks

Study Arms (1)

Patients treated with NeuroStar TMS

Device: NeuroStar Advanced TMS Therapy System

Interventions

NeuroStar Advanced TMS Therapy SystemDEVICE

non-invasive brain stimulation device

Patients treated with NeuroStar TMS

Eligibility Criteria

Age5 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Incomplete information on treatment parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuronetics

Malvern, Pennsylvania, 19355, United States

RECRUITING

MeSH Terms

Conditions

DepressionObsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAnxiety DisordersMental Disorders

Study Officials

  • Eleanor Cole, PhD

    Neuronetics

    STUDY DIRECTOR

Central Study Contacts

Neha Goyal

CONTACT

763-528-1599neha.goyal@neurostar.com

Eleanor Cole, PhD

CONTACT

415-724-7960Eleanor.cole@neurostar.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

April 8, 2025

Study Start

February 25, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

US(1)