NCT04956081Completed
Virtual Neuro-Navigation System for Personalized Community Based TMS
Source: ClinicalTrials.gov · Last updated 29 Sept 2025
Brief summary (registry, in English)
Phase I study of a virtual neuro-navigation package with built-in support for identifying specific "surface-based" targets to optimze TMS treatment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 16 Jun 2021
- Start date
- 1 Jul 2021
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Soterix Medical
- Diseases
- Depression
- NCT number
- NCT04956081
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 1 Jul 2021 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior non-response to ECT, vagal nerve stimulation (VNS) or deep brain stimulation (DBS)
- 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
Other illness
- Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder), anorexia nervosa or bulimia nervosa within the last year
- 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
- Requires 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
- Taking medications that increase the risk of seizures.
Lab values
- Unstable medical condition by history, physical exam or laboratory results
Other
- 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
- Actively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention.
- Lacks capacity to consent
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soterix Medical, Inc. Coordinator of this site? Confirm its status | Woodbridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.