Accelerated TMS for Depression and OCD

  • STATUS
    Recruiting
  • End date
    May 7, 2028
  • participants needed
    300
  • sponsor
    Weill Medical College of Cornell University
Updated on 4 October 2022
depression
MRI
depressive disorder
antidepressants
depressive symptoms
depressed mood
transcranial magnetic stimulation

Summary

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.

Details
Condition Depression, OCD
Treatment MagVenture MagPro System with Brainsight neuronavigation device
Clinical Study IdentifierNCT04982757
SponsorWeill Medical College of Cornell University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of major depressive disorder OR obsessive-compulsive disorder (DSM-V criteria)
Hamilton Depression Rating Scale score greater than or equal to 18 OR Yale-Brown Obsessive-Compulsive Scale score greater than or equal to 16
Failure to respond in the current episode to at least one antidepressant or other pharmacotherapy at an adequate dose and duration as measured by a modified antidepressant treatment history
Off antidepressants OR on a stable dose of antidepressants for greater than or equal to four weeks with plans to remain on this stable dose during the study
Capacity to consent

Exclusion Criteria

Imminent risk of suicide (based on the CSSRS)
Presence of primary psychiatric diagnoses other than OCD, MDD and/or co-morbid GAD (ex. PTSD, MDD with psychotic features, primary psychotic illness, Bipolar I or II)
Evidence of cognitive impairment (MMSE score falling 1 SD below mean score for his/her age and education)
Evidence of psychotic symptoms on diagnostic interview (interfering with capacity to consent)
Have met criteria for any significant substance use disorder within the past 6 months
Recent onset (within 8 weeks of screening) of psychotherapy
Prior exposure to 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)
Current pregnancy or planning to conceive during the study
Abnormal bloodwork for electrolytes, thyroid or liver function
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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