Virtual Neuro-Navigation System for Personalized Community Based TMS
Study Overview
Status
Conditions
Intervention / 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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Woodbridge, New Jersey, United States, 07095
- Soterix Medical, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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TMS delivered to a target within the left- dorsolateral prefrontal cortex (L-DLPFC)
Other Names:
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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.
|
TMS delivered to a target within the left- dorsolateral prefrontal cortex (L-DLPFC)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 2 times per week from Baseline until Week 6
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Depression severity scale where higher score indicates greater severity of symptoms
|
2 times per week from Baseline until Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)33
Time Frame: Baseline and at Week 6
|
six-item subscale of psychiatric disorder severity where higher score indicates greater severity of symptoms
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Baseline and at Week 6
|
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Side-effect form (SEF)
Time Frame: 2 times per week from Baseline until Week 6
|
clinician-rated simple form to document the onset, course, severity, and causality of adverse events
|
2 times per week from Baseline until Week 6
|
|
Columbia suicide severity rating scale (C-SSRS)
Time Frame: 2 times per week from Baseline until Week 6
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FDA approved scale for assessment of suicidality
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2 times per week from Baseline until Week 6
|
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Concomitant Medication List (CML)
Time Frame: 2 times per week from Baseline until Week 6
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This instrument will collect information on all concomitant medications
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2 times per week from Baseline until Week 6
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMICU061621
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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