Parcel-guided rTMS for Major Depressive Disorder

Soterix Medical

Status and phase: Not yet enrolling; Phase 2

Conditions: Treatment Resistant Depression (TRD)

Treatments: Device: Accelerated rTMS; Device: Parcel-guided Accelerated rTMS

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07287839

RTMSP2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Standard rTMS

Active Comparator group

Description:

rTMS using standard targeting (Beam-F3) will be delivered

Treatment:

Device: Accelerated rTMS

Parcel-guided rTMS

Experimental group

Description:

rTMS will be delivered using brain-surface parcellation targeting

Treatment:

Device: Parcel-guided Accelerated rTMS