Treatment Resistant DepressionNCT05598931
Development of Neuro-Navigated Transcranial Magnetic Stimulation (TMS) Using MRI
An observational study of Treatment Resistant Depression, run by Soterix Medical at 1 site in United States.
Trial summary
Healthy controls (HC) will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in which various TMS coil positions will be recorded. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Oct 2024
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Adult
Study population: Healthy Controls
Who may be able to join
- Non-depressed subjects
Who cannot join
- Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder); anorexia nervosa or bulimia nervosa within the last year
- Unstable medical condition by history, physical exam or laboratory results
- Contraindications to MRI (based on metal screening form)
- Meets criteria for claustrophobia
- Recent drug or alcohol use disorder with DSM-5 specifier of moderate or severe within 6 months, or mild within 2 months; lifetime history of IV drug use
- A neurological or neuromuscular disorder;
Show all 11Show fewer
- Require medications for a general medical condition that contraindicate the TMS treatment
- History of ketamine treatment within 6 mo
- History of monoamine oxidase inhibitor (MAOI) within the past month
- Lacks capacity to consent
- Taking medications that increase the risk of seizures. For patients on permitted concomitant psychotropic agents (antidepressants, anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, lmethylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Healthy controls (HC) will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in which various TMS coil positions will be recorded. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample.
Read the detailed description
HC subjects (n=10)/yr will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single Human Connectome Project compatible MRI session permitting application of both surface-based and more standard volumetric analyses. Subjects will then participate in an on-line neuro-navigation session in which TMS coil positions (in 10/20 coordinate space) will be recorded corresponding to the following targets: 1) hand-representation of motor strip; 2) 5-cm location; 3) 5.5 cm location; 4) MNI coordinates corresponding to the "Fitzgerald"4 and "Weigand"6 volumetric targets; 5) peak anti-correlated region (calculated from rsfcfMRI data alone); 6) center of our targeted parcel, calculated using surface-based approaches. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample. The Go/No-go criterion is an interclass correlation coefficient (ICC) of >.9 between scalp coordinates determined by on-line neuro-navigation and those determined virtually
- Conditions
- Treatment Resistant Depression
- Being tested
- Transcranial Magnetic Stimulation
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Subjects will participate in an on-line neuro-navigation session in which 6 TMS coil positions will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Subjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in which various TMS coil positions will be recorded. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Coordinates
MRI based brain coordinates will be determined using newly developed neuronavigation software
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Jul 2021
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant 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
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soterix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598931
- Sponsor's protocol ID
- SMICU061621B
- Status last verified
- Sep 2025
- First submitted
- 16 Jun 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Neuro-Navigated Transcranial Magnetic Stimulation (TMS) Using MRI
- ClinicalTrials.gov ID
- NCT05598931
- Acronym / sponsor ID
- SMICU061621B
- Conditions
- Treatment Resistant Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Soterix MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Columbia University
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 28 Oct 2022 (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.
Healthy controls (HC) will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in which various TMS coil positions will be recorded. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample.
Detailed description
HC subjects (n=10)/yr will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single Human Connectome Project compatible MRI session permitting application of both surface-based and more standard volumetric analyses. Subjects will then participate in an on-line neuro-navigation session in which TMS coil positions (in 10/20 coordinate space) will be recorded corresponding to the following targets: 1) hand-representation of motor strip; 2) 5-cm location; 3) 5.5 cm location; 4) MNI coordinates corresponding to the "Fitzgerald"4 and "Weigand"6 volumetric targets; 5) peak anti-correlated region (calculated from rsfcfMRI data alone); 6) center of our targeted parcel, calculated using surface-based approaches. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample. The Go/No-go criterion is an interclass correlation coefficient (ICC) of >.9 between scalp coordinates determined by on-line neuro-navigation and those determined virtually
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Device: Transcranial Magnetic StimulationSubjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in which various TMS coil positions will be recorded. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy Controls
Key inclusion criteria (1 listed)
- Non-depressed subjects
Key exclusion criteria (11 listed)
- Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder); anorexia nervosa or bulimia nervosa within the last year
- Unstable medical condition by history, physical exam or laboratory results
- Contraindications to MRI (based on metal screening form)
- Meets criteria for claustrophobia
- Recent drug or alcohol use disorder with DSM-5 specifier of moderate or severe within 6 months, or mild within 2 months; lifetime history of IV drug use
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 |
|---|---|---|
| Transcranial Magnetic StimulationSubjects will participate in an on-line neuro-navigation session in which 6 TMS coil positions will be recorded. | Device | Healthy Controls |
Primary outcome
Brain Coordinates
Time frame: Day 1
MRI based brain coordinates will be determined using newly developed neuronavigation software
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 29 Sep 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Treatment Resistant Depression, run by Soterix Medical 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 1 inclusion and 11 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 29 Sep 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?
Brain Coordinates (time frame: Day 1). 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 29 Sep 2025.