Clinical trial NCT04956081: Virtual Neuro-Navigation System for Personalized Community Based TMS
Official title: Virtual Neuro-Navigation System for Personalized Community Based TMS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment Resistant Depression
Lead sponsor: Soterix Medical
Sponsor class: INDUSTRY
Collaborators: name: Columbia University
First posted: 2021-07-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Phase I open-label, 12 subjects
Primary purpose: TREATMENT

Brief summary: 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

Eligibility 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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 2 times per week from Baseline until Week 6
Secondary outcomes:
measure: Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)33
timeFrame: Baseline and at Week 6
measure: Side-effect form (SEF)
timeFrame: 2 times per week from Baseline until Week 6
measure: Columbia suicide severity rating scale (C-SSRS)
timeFrame: 2 times per week from Baseline until Week 6
measure: Concomitant Medication List (CML)
timeFrame: 2 times per week from Baseline until Week 6
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Docs
state: New York
Study officials:
References: