Virtual Neuro-Navigation System for Personalized Community Based TMS

Sponsor
Soterix Medical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04956081
Collaborator
Columbia University (Other)
12
1
2
55
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Neuro-navigated Transcranial Magnetic Stimulation (TMS)
Phase 1

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

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Phase I open-label, 12 subjectsPhase I open-label, 12 subjects
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Virtual Neuro-Navigation System for Personalized Community Based TMS
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jan 31, 2026
Anticipated Study Completion Date :
Jan 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: virtual neuro-navigation

The specific area within the L-DLPFC will be identified by a software using MR images. TMS will be administered to the identified area.

Device: Neuro-navigated Transcranial Magnetic Stimulation (TMS)
TMS delivered to a target within the left- dorsolateral prefrontal cortex (L-DLPFC)
Other Names:
  • Transcranial Magnetic Stimulation
  • Experimental: on-line neuro-navigation

    The specific area within the L-DLPFC will be identified by a person using MR images. TMS will be administered to the identified area.

    Device: Neuro-navigated Transcranial Magnetic Stimulation (TMS)
    TMS delivered to a target within the left- dorsolateral prefrontal cortex (L-DLPFC)
    Other Names:
  • Transcranial Magnetic Stimulation
  • Outcome Measures

    Primary Outcome Measures

    1. Montgomery-Asberg Depression Rating Scale (MADRS) [2 times per week from Baseline until Week 6]

      Depression severity scale where higher score indicates greater severity of symptoms

    Secondary Outcome Measures

    1. Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)33 [Baseline and at Week 6]

      six-item subscale of psychiatric disorder severity where higher score indicates greater severity of symptoms

    2. Side-effect form (SEF) [2 times per week from Baseline until Week 6]

      clinician-rated simple form to document the onset, course, severity, and causality of adverse events

    3. Columbia suicide severity rating scale (C-SSRS) [2 times per week from Baseline until Week 6]

      FDA approved scale for assessment of suicidality

    4. Concomitant Medication List (CML) [2 times per week from Baseline until Week 6]

      This instrument will collect information on all concomitant medications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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; 9) Require 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 TMS-naïve subjects, prior history of TMS treatment. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia Docs New York New York United States 10019

    Sponsors and Collaborators

    • Soterix Medical
    • Columbia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soterix Medical
    ClinicalTrials.gov Identifier:
    NCT04956081
    Other Study ID Numbers:
    • SMICU061621
    First Posted:
    Jul 9, 2021
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 14, 2022