Major Depressive Disorder (MDD)NCT06772987
NQ TMS for MDD Therapy Using 1 Day x 3 Sessions Protocol for Adult Patient
A study testing Accelerated rTMS treatment in people with Major Depressive Disorder (MDD), run by NeuroQore Inc. at 1 site 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 (MDD)
- What is being tested?
- Accelerated rTMS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2025to 6 May 2025
- 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.
- Failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
- MADRS score > 20 at baseline and immediately prior to the day of treatment.
- Agrees to adhere to the study treatment and follow-up schedule.
- Willingness to remain on stable medications during rTMS therapy.
- 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 CSSRS 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
1 site in 1 country.
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 clinical trial is to evaluate the safety and effectiveness of an accelerated but shortened TMS dosing regimen for adults with MDD aged 22-85.
Participants in this study will be subjected to the same 19-minutes treatment session, but three times on the same day, and only for one day. This will greatly reduce the logistical burden of completing the therapy regime.
Read the detailed description
Study Description:
This single center, open label study will evaluate the safety and efficacy of accelerating the delivery of the NeuroQore TMS system's rectangular waveform rTMS protocol for the treatment of adults with MDD aged 22-85.
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 TMS system, with accelerated delivery in the treatment of adults with MDD, as measured by a change in MADRS score 24 hours and 7 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.
Endpoints:
Primary
- Change in MADRS score from baseline to 24 hours and 7 days post-treatment.
- Number and type of adverse events. Secondary
- Change in PHQ-9 score from baseline to 24 hours and 7 days post-treatment.
Study Population:
Men and women 22-85 with MDD that have failed one medication in the current episode.
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 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 6 months including enrollment and follow-up. Individual participant duration in the study will be 1 day of treatment, 24-hour and 7-day follow-up.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Accelerated rTMS treatment
- Keywords
- Major Depressive Disorder, 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.
Accelerated rTMS treatmentDevice
1 Day x 3 Sessions of 19-minutes rTMS treatment, with 60 minutes rest between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Protocol | Experimental | 1 Day x 3 Sessions treatment protocol, with 60 minutes rest between sessions. Each session is a 19-minutes rTMS treatment. Receives: Device: Accelerated rTMS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS) Score
Change in MADRS score from baseline to immediately post treatment, 24 hours and 7 days post-treatment
Measured: From enrollment to final MADRS score assessment within 2 weeks.
Secondary outcomes (1)
Patient Health Questionnaire-9 (PHQ-9) Score
Change in PHQ-9 score from baseline to immediately post treatment, 24 hours and 7 days post-treatment
Measured: From enrollment to final PHQ-9 score assessment within 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start16 Jan 2025
- Primary completion6 May 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroQore Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Makromed Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772987
- Sponsor's protocol ID
- CL-NQ-2024-01
- Other IDs
- BRANY IRB File #24-02-624-1959
- Status last verified
- May 2025
- First submitted
- 9 Jan 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: PII and Proprietary data will likely not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. 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
- NCT06772987
- Acronym / sponsor ID
- CL-NQ-2024-01
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major Depressive Disorder, Accelerated Treatment, 1-Day Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NeuroQore Inc.Industry (pharma, biotech, devices)
- Collaborators
- Makromed Inc.
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 14 Jan 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.
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 clinical trial is to evaluate the safety and effectiveness of an accelerated but shortened TMS dosing regimen for adults with MDD aged 22-85.
Participants in this study will be subjected to the same 19-minutes treatment session, but three times on the same day, and only for one day. This will greatly reduce the logistical burden of completing the therapy regime.
Detailed description
Study Description:
This single center, open label study will evaluate the safety and efficacy of accelerating the delivery of the NeuroQore TMS system's rectangular waveform rTMS protocol for the treatment of adults with MDD aged 22-85.
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 TMS system, with accelerated delivery in the treatment of adults with MDD, as measured by a change in MADRS score 24 hours and 7 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.
Endpoints:
Primary
- Change in MADRS score from baseline to 24 hours and 7 days post-treatment.
- Number and type of adverse events. Secondary
- Change in PHQ-9 score from baseline to 24 hours and 7 days post-treatment.
Study Population:
Men and women 22-85 with MDD that have failed one medication in the current episode.
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 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 6 months including enrollment and follow-up. Individual participant duration in the study will be 1 day of treatment, 24-hour and 7-day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label study
| Arm | Type | Receives |
|---|---|---|
| Accelerated Protocol | Experimental | Device: Accelerated rTMS treatment1 Day x 3 Sessions treatment protocol, with 60 minutes rest between sessions. Each session is a 19-minutes rTMS treatment. |
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.
- Failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
- 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 |
|---|---|---|
| Accelerated rTMS treatment1 Day x 3 Sessions of 19-minutes rTMS treatment, with 60 minutes rest between sessions. | Device | Accelerated Protocol |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS) Score
Time frame: From enrollment to final MADRS score assessment within 2 weeks.
Change in MADRS score from baseline to immediately post treatment, 24 hours and 7 days post-treatment
1 secondary outcome
Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: From enrollment to final PHQ-9 score assessment within 2 weeks.
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 13 May 2025.
- Individual participant dataSharing planned: Undecided. PII and Proprietary data will likely not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated rTMS treatment in people with Major Depressive Disorder (MDD), run by NeuroQore Inc. 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 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 13 May 2025. 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?
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?
Montgomery-Åsberg Depression Rating Scale (MADRS) Score (time frame: From enrollment to final MADRS score assessment within 2 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 13 May 2025.