Accelerated TMS for Depression and OCD

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04982757
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MagVenture MagPro System with Brainsight neuronavigation device — DEVICE
    10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.

Study Details

Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment for depression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn how to optimize the treatment to improve symptoms of depression and OCD. This research project will test a new accelerated 5-day accelerated rTMS protocol for treating symptoms of depression and OCD. A second goal of this study is to identify biomarkers of depression and OCD in the brain using functional magnetic resonance imaging (fMRI). This approach will predict who will benefit from TMS, determine the optimal treatment target, and improve treatment outcomes. Subjects will receive a clinical assessment of symptoms and an fMRI brain scan before and after each treatment course to measure the effect of treatment on symptom severity and on fMRI measures of functional connectivity. Participants will be randomized to receive rTMS targeting either the lateral prefrontal cortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a 5-day course of rTMS delivered hourly for 10 hours per day. Participants who show a partial response to treatment but not a full response will then receive a second 5-day course. Treatment non-responders will be crossed over to receive rTMS targeting the opposite brain area. The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement in symptoms for patients with depression and OCD in just 5 days, and that response rates can be further improved by adding a second 5-day treatment course.

Key Dates

Start date
Dec 7, 2021
Status verified
Feb 2026
Primary completion
May 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Depression - DMPFC target to (for non-responders) LPFC target
    Participants with treatment resistant depression will receive a 5-day course of rTMS delivered to the DMPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (LPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.
  • Active Comparator: Depression - LPFC target to (for non-responders) DMPFC target
    Participants with treatment resistant depression will receive a 5-day course of rTMS delivered to the LPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (DMPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.
  • Experimental: OCD - DMPFC target to (for non-responders) LPFC target
    Participants with OCD will receive a 5-day course of rTMS delivered to the DMPFC.Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (LPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.
  • Active Comparator: OCD - LPFC target to (for non-responders) DMPFC target
    Participants with OCD will receive a 5-day course of rTMS delivered to the LPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (DMPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.

Primary Outcome Measure

Percent Change in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores for participants with OCD [ Time Frame: Baseline to Treatment End: Day 5, 10, 15, or 20 (depending on number of 5-day treatment courses administered) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Megan Johnson
[email protected]
646-962-2900
Conor Liston, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Weill Cornell Medicine· New York, NY

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