Treatment Resistant DepressionNCT04956081
Virtual Neuro-Navigation System for Personalized Community Based TMS
A study testing Neuro-navigated Transcranial Magnetic Stimulation (TMS) in people with Treatment Resistant Depression, run by Soterix Medical at 1 site in United States.
Trial summary
Phase I study of a virtual neuro-navigation package with built-in support for identifying specific "surface-based" targets to optimze TMS treatment. 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?
- Neuro-navigated Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Sep 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
- Met criteria for treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ, as well as an adequate course of TMS treatment using standard targeting approaches (e.g. 5-cm, 5.5-cm, F3)
- at least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20
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
- Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
- 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
Show all 15Show fewer
- Actively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention.
- A neurological or neuromuscular disorder
- Requires medications for a general medical condition that contraindicate the TMS treatment
- Prior non-response to ECT, vagal nerve stimulation (VNS) or deep brain stimulation (DBS)
- 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, l-methylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry and patients must agree to continue at the same dose during the study
Trial locations and contacts
1 site in 1 country.
About this study
Phase I study of a virtual neuro-navigation package with built-in support for identifying specific "surface-based" targets to optimze TMS treatment.
Read the detailed description
Background: Personalized MR neuro-navigation-based targeting approaches have been developed that have the potential to greatly increase TMS efficacy. Nevertheless, these have yet to be incorporated into routine clinical practice because of issues related to 1) the feasibility of neuro-navigation when applied to routine clinical practice, and 2) lack of biomarker-based validation of the critical target across individuals. Recent research at CU has begun to address both feasibility and targeting issues. In the MR-guided neuro-navigation approach, either structural or functional brain scans are used to identify a specific region of interest and the neuro-navigation system is then used to position the TMS coil to target that specific region across individuals. While this approach can be applied within specialized treatment settings, use of these devices requires expertise in 3D brain reconstruction that the majority of TMS providers do not possess. At CU, an initiative is underway to develop a "virtual neuro-navigation" system in which MRI images of the head and brain are uploaded into a server and neuro-navigation is performed "in silico" rather than in person. Scalp coordinates are then relayed to the clinician.
Study: Under this phase I study, Soterix Medical would develop an initial version of the software ("TMSMap") and CU would perform feasibility testing on patients with treatment resistant depression
- Conditions
- Treatment Resistant Depression
- Being tested
- Neuro-navigated Transcranial Magnetic Stimulation (TMS)
- 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.
Neuro-navigated Transcranial Magnetic Stimulation (TMS)Device
Also called Transcranial Magnetic Stimulation
TMS delivered to a target within the left- dorsolateral prefrontal cortex (L-DLPFC)
| Study group | Role | What they receive |
|---|---|---|
| virtual neuro-navigation | Experimental | The specific area within the L-DLPFC will be identified by a software using MR images. TMS will be administered to the identified area. Receives: Device: Neuro-navigated Transcranial Magnetic Stimulation (TMS) |
| on-line neuro-navigation | Experimental | The specific area within the L-DLPFC will be identified by a person using MR images. TMS will be administered to the identified area. Receives: Device: Neuro-navigated Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
Depression severity scale where higher score indicates greater severity of symptoms
Measured: 2 times per week from Baseline until Week 6
Secondary outcomes (4)
Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)33
six-item subscale of psychiatric disorder severity where higher score indicates greater severity of symptoms
Measured: Baseline and at Week 6
Side-effect form (SEF)
clinician-rated simple form to document the onset, course, severity, and causality of adverse events
Measured: 2 times per week from Baseline until Week 6
Columbia suicide severity rating scale (C-SSRS)
FDA approved scale for assessment of suicidality
Measured: 2 times per week from Baseline until Week 6
Concomitant Medication List (CML)
This instrument will collect information on all concomitant medications
Measured: 2 times per week from Baseline until Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Jul 2021
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase I open-label, 20 subjects
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT04956081
- Sponsor's protocol ID
- SMICU061621
- 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
- Virtual Neuro-Navigation System for Personalized Community Based TMS
- ClinicalTrials.gov ID
- NCT04956081
- Acronym / sponsor ID
- SMICU061621
- Conditions
- Treatment Resistant Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Soterix MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Columbia University
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 9 Jul 2021 (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.
Phase I study of a virtual neuro-navigation package with built-in support for identifying specific "surface-based" targets to optimze TMS treatment.
Detailed description
Background: Personalized MR neuro-navigation-based targeting approaches have been developed that have the potential to greatly increase TMS efficacy. Nevertheless, these have yet to be incorporated into routine clinical practice because of issues related to 1) the feasibility of neuro-navigation when applied to routine clinical practice, and 2) lack of biomarker-based validation of the critical target across individuals. Recent research at CU has begun to address both feasibility and targeting issues. In the MR-guided neuro-navigation approach, either structural or functional brain scans are used to identify a specific region of interest and the neuro-navigation system is then used to position the TMS coil to target that specific region across individuals. While this approach can be applied within specialized treatment settings, use of these devices requires expertise in 3D brain reconstruction that the majority of TMS providers do not possess. At CU, an initiative is underway to develop a "virtual neuro-navigation" system in which MRI images of the head and brain are uploaded into a server and neuro-navigation is performed "in silico" rather than in person. Scalp coordinates are then relayed to the clinician.
Study: Under this phase I study, Soterix Medical would develop an initial version of the software ("TMSMap") and CU would perform feasibility testing on patients with treatment resistant depression
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I open-label, 20 subjects
| Arm | Type | Receives |
|---|---|---|
| virtual neuro-navigation | Experimental | Device: Neuro-navigated Transcranial Magnetic Stimulation (TMS)The specific area within the L-DLPFC will be identified by a software using MR images. TMS will be administered to the identified area. |
| on-line neuro-navigation | Experimental | Device: Neuro-navigated Transcranial Magnetic Stimulation (TMS)The specific area within the L-DLPFC will be identified by a person using MR images. TMS will be administered to the identified area. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
- Met criteria for treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ, as well as an adequate course of TMS treatment using standard targeting approaches (e.g. 5-cm, 5.5-cm, F3)
- at least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20
Key exclusion criteria (15 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
- Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
- Contraindications to MRI (based on metal screening form)
- Meets criteria for claustrophobia
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 |
|---|---|---|
| Neuro-navigated Transcranial Magnetic Stimulation (TMS)Also: Transcranial Magnetic StimulationTMS delivered to a target within the left- dorsolateral prefrontal cortex (L-DLPFC) | Device | on-line neuro-navigation, virtual neuro-navigation |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 2 times per week from Baseline until Week 6
Depression severity scale where higher score indicates greater severity of symptoms
4 secondary outcomes
Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)33
Time frame: Baseline and at Week 6
Side-effect form (SEF)
Time frame: 2 times per week from Baseline until Week 6
Columbia suicide severity rating scale (C-SSRS)
Time frame: 2 times per week from Baseline until Week 6
Concomitant Medication List (CML)
Time frame: 2 times per week from Baseline until Week 6
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?
A study testing Neuro-navigated Transcranial Magnetic Stimulation (TMS) in people with 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 3 inclusion and 15 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?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 2 times per week from Baseline until Week 6). 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.