Major Depressive DisorderNCT07369180
NQ Square TMS for Major Depressive Disorder: One Day, Three Sessions in Adults
A study testing Active Accelerated rTMS Treatment in people with Major Depressive Disorder, run by NeuroQore Inc. at 2 sites in United States.
Trial summary
Transcranial Magnetic Stimulation (TMS) Therapy is a non-invasive procedure that uses magnetic pulses to stimulate the cortex (brain) to treat Major Depressive Disorder (MDD). Currently established therapy uses one 19-minute treatment session per day for 5 days per week for 6 weeks, for a total of 30 treatment… Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Active Accelerated rTMS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2026to 18 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 22-85.
- Current diagnosis of major depressive disorder according to the criteria defined in the current Diagnosis and Statistical Manual of Mental Disorders (DSM-V) without psychotic features. The diagnosis of DSM-5 criteria-defined MDD will be made by a psychiatrist in light of a comprehensive psychiatric evaluation and other available clinical data.
- Drug-resistant MDD (lack of improvement on antidepressant medication in the current episode, despite adequate dose and duration and adherence to treatment).
- MADRS score > 20 at baseline and immediately prior to the day of treatment.
- Agrees to adhere to the study treatment and follow-up schedule.
- Evidence of no change in AD medications or psychotherapy from 4 weeks prior to enrollment and participant's agreement not to request such changes through 2 weeks after study regimen treatment.
- Fluent in English.
Who cannot join
- Any medical conditions that would preclude the use of rTMS to treat depression.
- Any conditions that would prevent the ability to undergo MRI testing.
- Pregnancy as determined by serum/urine pregnancy test
- History of epilepsy, seizure(s), or a seizure disorder as determined by the principal investigator based on a medical history obtained from the patient and/or others authorized to provide such history, combined with a brief screening instrument.
- Active substance abuse
- Diagnosis of bipolar or psychotic disorder
- Considered to be at moderate-high risk of suicide according to the C-SSRS assessment (i.e., Answers YES to Question 3 and NO to Question 6; or answers YES to Question 4, 5, or 6)
- As determined by the Principal Investigator, subjects with cognitive impairment according to either the medical history obtained from the patient and/or a reliable secondary source, or the results of the Montreal Cognitive Assessment (MoCA) performed during screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
LGTC Group
Campbell, California, 95008
LGTC Group
Sunnyvale, California, 94086
About this study
Official title: Safety and Efficacy of an Accelerated, Rectangular Waveform rTMS Protocol in Treatment of Adults With Major Depressive Disorder.
Transcranial Magnetic Stimulation (TMS) Therapy is a non-invasive procedure that uses magnetic pulses to stimulate the cortex (brain) to treat Major Depressive Disorder (MDD). Currently established therapy uses one 19-minute treatment session per day for 5 days per week for 6 weeks, for a total of 30 treatment sessions.
The goal of this multi-site sham-controlled double-blinded randomized clinical trial is to evaluate the safety and effectiveness of accelerating the delivery of the NeuroQore Square TMS system's rectangular waveform rTMS protocol for the treatment of adults aged 22-85 with Major Depressive Disorder.
The accelerated protocol of this study will involve the same currently FDA-cleared 19-min treatment session offered three times in a single day, with no additional treatment sessions.
Read the detailed description
Study Description:
This multi-site sham-controlled double-blinded randomized study will evaluate the safety and efficacy of accelerating the delivery of the NeuroQore Square TMS system's rectangular waveform rTMS protocol for the treatment of adults aged 22-85 with Major Depressive Disorder.
Currently cleared protocol with the FDA (the Standard of Care Protocol) is one 19-min treatment session a day for 5 days/week for 6 weeks. The accelerated protocol will involve the same 19-min treatment session offered three times in a single day, with no additional treatment sessions.
Primary Objectives:
- To assess the efficacy of the NeuroQore Square TMS system, with accelerated delivery, in the treatment of adults with major depressive disorder as measured by a change in MADRS score 24 hours, 7 days and 30 days after the treatment end.
- To compare the safety profile of the accelerated delivery protocol to the historical safety profile of the Standard of Care protocol.
End Points:
Primary
- Change in MADRS score from baseline to 24 hours, 7 days and 30 days post-treatment.
- Number and type of adverse events.
Secondary
- Change in PHQ-9 score from baseline to 24 hours, 7 days and 30 days post-treatment.
Study Population:
Men and women 22-85 with major depressive disorder that have failed one medication in the current episode. Its demographics will reflect variations in race, ethnicity, residence status (urban, suburban, rural), and socioeconomic status (education, profession).
Study Intervention:
NeuroQore TMS System includes (1) a pulse generator, (2) a magnetic coil, (3) a coil cooler, and (4) a chair with a headpiece. It has been cleared for clinical use (K232688) by the FDA for the treatment of Major Depressive Disorder (MDD) using a 19-min Standard of Care protocol.
Treatment during this study will be administered according to this protocol and following the instructions in the device user manual. Personalized stimulation targets will be produced from participants' structural MRI via the proprietary targeting generation component of the NeuroQore TMS system.
Only personnel trained and certified by NeuroQore will be permitted to administer treatment. All session and device information will be captured on appropriate data collection forms.
Study Duration:
The study is anticipated to last up to 3 months including enrollment and follow-up.
Individual participant duration in the study will be 1 day of treatment, 24- hour, 7-day and 30-day follow-up.
- Conditions
- Major Depressive Disorder
- Being tested
- Active Accelerated rTMS Treatment, Sham Accelerated rTMS Treatment
- Keywords
- Major Depressive Disorder (MDD), Accelerated Treatment, 1-day Treatment
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Accelerated rTMS TreatmentDevice
1 Day x 3 Sessions of 19-minutes active rTMS treatment, with 60 minutes rest between sessions.
Sham Accelerated rTMS TreatmentDevice
1 Day x 3 Sessions of 19-minutes sham rTMS treatment, with 60 minutes rest between sessions. It simulates the treatment regimen but blocks the treatment from reaching the target in Cortex.
| Study group | Role | What they receive |
|---|---|---|
| Active Accelerated Protocol | Experimental | Three 19-min TMS treatment protocol delivered on the same day, with 1 hour rest between the sessions. Receives: Device: Active Accelerated rTMS Treatment |
| Sham Accelerated Protocol | Sham comparator | Three 19-min TMS treatment protocol simulated but blocked from delivery to the target region in Cortex, on the same day, with 1 hour rest between the sessions. Receives: Device: Sham Accelerated rTMS Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to immediately post-treatment, 24 hours, 7 days and 30 days post-treatment. The MADRS is a 10-item clinician-rated scale; total score ranges from 0 to 60, with higher scores indicating more severe depression (worse outcome).
Measured: Baseline (treatment day, pre-treatment), immediately post-treatment, 24 hours, 7 days and 30 days post-treatment
Secondary outcomes (1)
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score
Change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to immediately post-treatment, 24 hours, 7 days and 30 days post-treatment. The PHQ-9 is a 9-item self-report scale; total score ranges from 0 to 27, with higher scores indicating more severe depression (worse outcome).
Measured: Baseline (treatment day, pre-treatment), immediately post-treatment, 24 hours, 7 days and 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start15 Jan 2026
- Primary completion9 Mar 2026
- Study completion18 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects will be randomly and in double-blind manner (blind to investigator and participant) provided the active or sham treatment with NeuroQore's TMS system using a neuro-navigation system utilizing MRI to identify individualized target area for stimulation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroQore Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karthik Ramgopal, DO, Principal investigator, LGTC Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369180
- Sponsor's protocol ID
- CL-NQ-2025-01
- Other IDs
- BRANY IRB File #2-02-5-1959
- Status last verified
- Oct 2026
- First submitted
- 24 Jan 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified individual participant data will not be made available to other researchers. The data set is part of a regulatory submission to the U.S. FDA, and participant consent under HIPAA and California privacy law did not include external data sharing. Aggregate results will be posted on ClinicalTrials.gov and published.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Accelerated, Rectangular Waveform rTMS Protocol in Treatment of Adults With Major Depressive Disorder.
- ClinicalTrials.gov ID
- NCT07369180
- Acronym / sponsor ID
- CL-NQ-2025-01
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder (MDD), Accelerated Treatment, 1-day Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- NeuroQore Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 18 Jun 2026 (actual)
- First posted
- 27 Jan 2026 (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.
Transcranial Magnetic Stimulation (TMS) Therapy is a non-invasive procedure that uses magnetic pulses to stimulate the cortex (brain) to treat Major Depressive Disorder (MDD). Currently established therapy uses one 19-minute treatment session per day for 5 days per week for 6 weeks, for a total of 30 treatment sessions.
The goal of this multi-site sham-controlled double-blinded randomized clinical trial is to evaluate the safety and effectiveness of accelerating the delivery of the NeuroQore Square TMS system's rectangular waveform rTMS protocol for the treatment of adults aged 22-85 with Major Depressive Disorder.
The accelerated protocol of this study will involve the same currently FDA-cleared 19-min treatment session offered three times in a single day, with no additional treatment sessions.
Detailed description
Study Description:
This multi-site sham-controlled double-blinded randomized study will evaluate the safety and efficacy of accelerating the delivery of the NeuroQore Square TMS system's rectangular waveform rTMS protocol for the treatment of adults aged 22-85 with Major Depressive Disorder.
Currently cleared protocol with the FDA (the Standard of Care Protocol) is one 19-min treatment session a day for 5 days/week for 6 weeks. The accelerated protocol will involve the same 19-min treatment session offered three times in a single day, with no additional treatment sessions.
Primary Objectives:
- To assess the efficacy of the NeuroQore Square TMS system, with accelerated delivery, in the treatment of adults with major depressive disorder as measured by a change in MADRS score 24 hours, 7 days and 30 days after the treatment end.
- To compare the safety profile of the accelerated delivery protocol to the historical safety profile of the Standard of Care protocol.
End Points:
Primary
- Change in MADRS score from baseline to 24 hours, 7 days and 30 days post-treatment.
- Number and type of adverse events.
Secondary
- Change in PHQ-9 score from baseline to 24 hours, 7 days and 30 days post-treatment.
Study Population:
Men and women 22-85 with major depressive disorder that have failed one medication in the current episode. Its demographics will reflect variations in race, ethnicity, residence status (urban, suburban, rural), and socioeconomic status (education, profession).
Study Intervention:
NeuroQore TMS System includes (1) a pulse generator, (2) a magnetic coil, (3) a coil cooler, and (4) a chair with a headpiece. It has been cleared for clinical use (K232688) by the FDA for the treatment of Major Depressive Disorder (MDD) using a 19-min Standard of Care protocol.
Treatment during this study will be administered according to this protocol and following the instructions in the device user manual. Personalized stimulation targets will be produced from participants' structural MRI via the proprietary targeting generation component of the NeuroQore TMS system.
Only personnel trained and certified by NeuroQore will be permitted to administer treatment. All session and device information will be captured on appropriate data collection forms.
Study Duration:
The study is anticipated to last up to 3 months including enrollment and follow-up.
Individual participant duration in the study will be 1 day of treatment, 24- hour, 7-day and 30-day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The subjects will be randomly and in double-blind manner (blind to investigator and participant) provided the active or sham treatment with NeuroQore's TMS system using a neuro-navigation system utilizing MRI to identify individualized target area for stimulation.
| Arm | Type | Receives |
|---|---|---|
| Active Accelerated Protocol | Experimental | Device: Active Accelerated rTMS TreatmentThree 19-min TMS treatment protocol delivered on the same day, with 1 hour rest between the sessions. |
| Sham Accelerated Protocol | Sham comparator | Device: Sham Accelerated rTMS TreatmentThree 19-min TMS treatment protocol simulated but blocked from delivery to the target region in Cortex, on the same day, with 1 hour rest between the sessions. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females aged 22-85.
- Current diagnosis of major depressive disorder according to the criteria defined in the current Diagnosis and Statistical Manual of Mental Disorders (DSM-V) without psychotic features. The diagnosis of DSM-5 criteria-defined MDD will be made by a psychiatrist in light of a comprehensive psychiatric evaluation and other available clinical data.
- Drug-resistant MDD (lack of improvement on antidepressant medication in the current episode, despite adequate dose and duration and adherence to treatment).
- MADRS score > 20 at baseline and immediately prior to the day of treatment.
- Agrees to adhere to the study treatment and follow-up schedule.
Key exclusion criteria (8 listed)
- Any medical conditions that would preclude the use of rTMS to treat depression.
- Any conditions that would prevent the ability to undergo MRI testing.
- Pregnancy as determined by serum/urine pregnancy test
- History of epilepsy, seizure(s), or a seizure disorder as determined by the principal investigator based on a medical history obtained from the patient and/or others authorized to provide such history, combined with a brief screening instrument.
- Active substance abuse
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 |
|---|---|---|
| Active Accelerated rTMS Treatment1 Day x 3 Sessions of 19-minutes active rTMS treatment, with 60 minutes rest between sessions. | Device | Active Accelerated Protocol |
| Sham Accelerated rTMS Treatment1 Day x 3 Sessions of 19-minutes sham rTMS treatment, with 60 minutes rest between sessions. It simulates the treatment regimen but blocks the treatment from reaching the target in Cortex. | Device | Sham Accelerated Protocol |
Primary outcome
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline (treatment day, pre-treatment), immediately post-treatment, 24 hours, 7 days and 30 days post-treatment
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to immediately post-treatment, 24 hours, 7 days and 30 days post-treatment. The MADRS is a 10-item clinician-rated scale; total score ranges from 0 to 60, with higher scores indicating more severe depression (worse outcome).
1 secondary outcome
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score
Time frame: Baseline (treatment day, pre-treatment), immediately post-treatment, 24 hours, 7 days and 30 days post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be made available to other researchers. The data set is part of a regulatory submission to the U.S. FDA, and participant consent under HIPAA and California privacy law did not include external data sharing. Aggregate results will be posted on ClinicalTrials.gov and published.
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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. This study is not recruiting at the moment.
Karthik Ramgopal, DO principal investigator
LGTC Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Accelerated rTMS Treatment in people with Major Depressive Disorder, run by NeuroQore Inc. at 2 sites 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline (treatment day, pre-treatment), immediately post-treatment, 24 hours, 7 days and 30 days post-treatment). 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 3 Nov 2026.