Virtual neuro-navigation system for personalized TMS treatment
Virtual Neuro-Navigation System for Personalized Community Based TMS
This study is testing a new virtual system that helps target brain treatment with Transcranial Magnetic Stimulation for people with depression who haven't found relief from other therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Soterix Medical Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04956081 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test a virtual neuro-navigation system designed to enhance the efficacy of Transcranial Magnetic Stimulation (TMS) for patients with treatment-resistant depression. By utilizing MRI scans to identify specific brain regions, the system allows for precise targeting of TMS treatment without the need for in-person neuro-navigation expertise. The initial version of the software, called 'TMSMap', will be developed by Soterix Medical, with feasibility testing conducted at Columbia University on eligible patients. The goal is to improve treatment outcomes for individuals who have not responded to standard depression therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with major depressive disorder who have not responded to multiple treatment trials.
Not a fit: Patients with psychotic disorders, unstable medical conditions, or those who are currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients suffering from treatment-resistant depression.
How similar studies have performed: While the use of neuro-navigation in TMS is established, this virtual approach is novel and has not been widely tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
New York, New York
- Columbia Docs — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Rashel Mejia, BS
- Email: rmejia@soterixmedical.com
- Phone: 18889908327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.