Parcel-guided rTMS for Major Depressive Disorder

Phase 2Not Yet RecruitingNCT07287839

Soterix Medical60 enrolled

Overview

Study comparing standard repetitive transcranial magnetic stimulation (rTMS) for Depression to a novel targeting approach using brain surface parcellation to locate a specific brain target.

Standard rTMS treatment often uses the "Beam-F3" targeting approach to locate a brain region known as the left dorsolateral prefrontal cortex (lDLPFC). However, Beam-F3 does not take into account interindividual variation in brain anatomy. Researchers as Columbia University have found a more accurate and personalized approach that uses MRI-based brain surface parcellation to locate the specific subregion of the lDLPFC most ideal for rTMS treatment. Our study is comparing standard rTMS (Beam-F3) to parcel-guided rTMS for patients with treatment resistant depression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Treatment Resistant Depression (TRD)

Interventions

Accelerated rTMSDEVICE

rTMS targeting will be done using the standard Beam-F3 targeting method. Treatment will be delivered in an accelerated schedule with 50 treatment session over 5 days.

Parcel-guided Accelerated rTMSDEVICE

rTMS targeting will be done using brain surface parcellation. Treatment will be delivered in an accelerated schedule with 50 treatment sessions over 5 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules * 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. * 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; or lifetime history of IV drug use A- ctively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention. * 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 months * 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

Outcomes

Primary Outcomes

Montgomery-Asberg Depression Rating Scale (MADRS)

Depression severity scale with a score ranging from 0 to 60 where a higher score indicates greater severity of symptoms.

Time frame: Baseline and at end of Week 1

Secondary Outcomes

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

six-item subscale of psychiatric disorder severity where a score is given between 0 and 18 and a higher score indicates greater severity of symptoms

Time frame: Baseline and at Week 1

Side-effect form (SEF)

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

Time frame: Daily from Baseline until Week 1

Columbia suicide severity rating scale (C-SSRS)

Rating scale for suicidal ideation with scores ranging from 0 to 5 where a higher score indicates greater severity of symptoms

Time frame: Baseline and Week 1

Central Contacts

Yishai Valter, MS

CONTACT

888-990-8327 trials@soterixmedical.com

Data from ClinicalTrials.gov

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