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NCT Number: NCT07287839

Parcel-guided rTMS for Major Depressive Disorder

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accelerated rTMS

Device

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 rTMS

Device

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

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline and at end of Week 1

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

Secondary outcomes

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

    Time frame: Baseline and at Week 1

    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

  2. Side-effect form (SEF)

    Time frame: Daily from Baseline until Week 1

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

  3. Columbia suicide severity rating scale (C-SSRS)

    Time frame: Baseline and Week 1

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yishai Valter, MS

CONTACT

[email protected]

888-990-8327

Sponsors and collaborators

Lead sponsor

Soterix Medical

Industry

Collaborators

  • Columbia University

Registry information

Official study title

Phase-2 Trial of Parcel-guided rTMS for Major Depressive Disorder

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 17, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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