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Virtual Neuro-Navigation System for Personalized Community Based TMS

Primary Purpose

Treatment Resistant Depression

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Neuro-navigated Transcranial Magnetic Stimulation (TMS)

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Columbia DocsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

virtual neuro-navigation

on-line neuro-navigation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS)

Depression severity scale where higher score indicates greater severity of symptoms

Secondary Outcome Measures

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

Side-effect form (SEF)

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

Columbia suicide severity rating scale (C-SSRS)

FDA approved scale for assessment of suicidality

Concomitant Medication List (CML)

This instrument will collect information on all concomitant medications

Full Information

NCT ID

NCT04956081

First Posted

June 16, 2021

Last Updated

April 10, 2023

Sponsor

Soterix Medical

Collaborators

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT04956081

Brief Title

Virtual Neuro-Navigation System for Personalized Community Based TMS

Official Title

Virtual Neuro-Navigation System for Personalized Community Based TMS

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

January 31, 2026 (Anticipated)

Study Completion Date

January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Soterix Medical

Collaborators

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment Resistant Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

Phase I open-label, 12 subjects

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

virtual neuro-navigation

Arm Type

Experimental

Arm Description

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

Arm Title

on-line neuro-navigation

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Neuro-navigated Transcranial Magnetic Stimulation (TMS)

Other Intervention Name(s)

Transcranial Magnetic Stimulation

Intervention Description

TMS delivered to a target within the left- dorsolateral prefrontal cortex (L-DLPFC)

Primary Outcome Measure Information:

Title

Montgomery-Asberg Depression Rating Scale (MADRS)

Description

Depression severity scale where higher score indicates greater severity of symptoms

Time Frame

2 times per week from Baseline until Week 6

Secondary Outcome Measure Information:

Title

Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)33

Description

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

Time Frame

Baseline and at Week 6

Title

Side-effect form (SEF)

Description

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

Time Frame

2 times per week from Baseline until Week 6

Title

Columbia suicide severity rating scale (C-SSRS)

Description

FDA approved scale for assessment of suicidality

Time Frame

2 times per week from Baseline until Week 6

Title

Concomitant Medication List (CML)

Description

This instrument will collect information on all concomitant medications

Time Frame

2 times per week from Baseline until Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yifan Gao, MA

Phone

18889908327

ygao@soterixmedical.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dennis Truong, PhD

Phone

18889908327

contact@soterixmedical.com

Facility Information:

Facility Name

Columbia Docs

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yifan Gao

Phone

888-990-8327

ygao@soterixmedical.com

12. IPD Sharing Statement

Plan to Share IPD

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Virtual Neuro-Navigation System for Personalized Community Based TMS

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