DepressionNCT06917339
Retrospective Analyses of TrakStar Database
An observational study of Depression and Obsessive-Compulsive Disorder, run by Neuronetics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 120 years
- Conditions the study is for
- Depression, Obsessive-Compulsive Disorder, Anxiety Depression
- What is being tested?
- NeuroStar Advanced TMS Therapy System
- Type of treatment
- Medical device
- How many people
- 156,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- Incomplete information on treatment parameters
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Neuronetics
Malvern, Pennsylvania, 19355
Eleanor Cole
About this study
Official title: 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.
- Being tested
- NeuroStar Advanced TMS Therapy System
- Keywords
- TMS
- Medical subject headings
- Depression, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroStar Advanced TMS Therapy SystemDevice
non-invasive brain stimulation device
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with NeuroStar TMS | Not described Receives: Device: NeuroStar Advanced TMS Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (1)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start25 Feb 2025
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 156,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuronetics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleanor Cole, PhD, Study director, Neuronetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917339
- Sponsor's protocol ID
- 11-10000-000
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analyses Evaluating the Real-World Effectiveness of NeuroStar® TMS and the Factors Associated With Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06917339
- Acronym / sponsor ID
- 11-10000-000
- Keywords
- TMS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 156,000 participants (estimated)
- Lead sponsor
- NeuroneticsUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with NeuroStar TMS | – | Device: NeuroStar Advanced TMS Therapy System |
Who may qualify
- Ages
- 5 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Incomplete information on treatment parameters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroStar Advanced TMS Therapy Systemnon-invasive brain stimulation device | Device | Patients treated with NeuroStar TMS |
Primary outcome
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
1 secondary outcome
Age at baseline and its correlation to change in score post treatment
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eleanor Cole, PhD study director
Neuronetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Obsessive-Compulsive Disorder, run by Neuronetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neha Goyal (763-528-1599, neha.goyal@neurostar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical assessment score from baseline to post-treatment (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.