Retrospective Analyses of TrakStar Database | NCT06917339

Studies
Retrospective Analyses of TrakStar Database

NCT06917339

Sponsor

Neuronetics

Status

Recruiting

Last Update Posted

Apr 9, 2026Actual

Enrollment

156,000Estimated

Phase

Not provided

Conditions

Depression
Obsessive-Compulsive Disorder
Anxiety Depression

Interventions

NeuroStar Advanced TMS Therapy System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2025Actual

Primary Completion Date

Dec 2035Estimated

Completion Date

Dec 2035Estimated

First Submitted Date

Mar 18, 2025

First Submission Date that Met QC Criteria

Mar 31, 2025

First Posted Date

Apr 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2026

Last Update Posted Date

Apr 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

156,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients treated with NeuroStar TMS			Device: NeuroStar Advanced TMS Therapy System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NeuroStar Advanced TMS Therapy System	Device	non-invasive brain stimulation device	Patients treated with NeuroStar TMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Neha Goyal	Contact	763-528-1599		neha.goyal@neurostar.com
Eleanor Cole, PhD	Contact	415-724-7960		Eleanor.cole@neurostar.com

Overall Officials

Name	Affiliation	Role
Eleanor Cole, PhD	Neuronetics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neuronetics	Recruiting	Malvern	Pennsylvania	19355	United States

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D009771	Obsessive-Compulsive Disorder

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided