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COVID-19 Compatible Accelerated TMS Therapy

Clinical Trial Details

Repetitive transcranial magnetic stimulation (rTMS) is an FDA-cleared treatment for depression and obsessive compulsive disorder (OCD) that uses focused magnetic field pulses to stimulate target brain areas. Multiple brain targets in the prefrontal cortex have shown consistent evidence of treatment efficacy in both depression and OCD, but there are currently no established methods for selecting the optimal target site in individual patients.

Additionally, rTMS may underperform or even fail if the rTMS regimen is under-dosed. Delivering an adequate dose of stimulation can be especially challenging during the COVID-19 pandemic, because standard protocols require patients to visit a clinical TMS suite daily for brief sessions for up to 42 days, which poses numerous logistical challenges during the pandemic.

In this open-label study, we will test a new 5-day accelerated rTMS protocol with established efficacy in two recent publications. Subjects will complete a 5-day course of rTMS delivered hourly for 10 hours per day. Subjects who show a partial response to treatment but not a full response will then receive a second 5-day course. The goals of the study are to determine the overall efficacy and trajectory of response to accelerated rTMS for depression or OCD in an open-label context and to identify predictors of differential response to each treatment.

Key Eligibility: 

Inclusion Criteria
   - Ages 18-75
   - Diagnosis of major depressive disorder OR obsessive-compulsive disorder
   - Failed at least 1 prior trial of standard first-line treatment for depression or OCD OR had refused these treatments for individual reasons
   - Off antidepressants OR on a stable dose of antidepressants for greater than or equal to four weeks
   - Capacity to consent
   
   Exclusion Criteria
   - Imminent risk of suicide
   - Presence of primary psychiatric diagnosis other than MDD or OCD
   - Evidence of cognitive impairment
   - Have met criteria for any significant substance use disorder within the past 6 months
   - Recent onset (within 8 weeks of screening) of psychotherapy
   - Prior completion of this accelerated TMS treatment protocol during the current depressive episode
   - Participated in any clinical trial with an investigational drug or device within the past 6 weeks prior to screening
   - Evidence or history of significant neurological disorder including moderate-severe head trauma, stroke, Parkinson's disease or other movement disorder (except benign essential tremor), epilepsy
   - History of seizures (except juvenile febrile seizures) or any condition/concurrent medication that could notably lower seizure threshold 
   - Presence of foreign metal bodies/implanted intracranial devices (MRI contraindication)
   - Currently pregnant or planning to conceive during the study period
   - Abnormal bloodwork for electrolytes, thyroid or liver function

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Megan Johnson
646-962-2900
tmsinfo@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2010022827

ClinicalTrials.gov:

NCT04982757

Sponsor:

2010022827

Status

Open to Enrollment

Age Group

Adult

Sponsor