Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment fordepression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn howto optimize the treatment to improve symptoms of depression and OCD. This researchproject will test a new accelerated 5-day accelerated rTMS protocol for treating symptomsof depression and OCD.A second goal of this study is to identify biomarkers of depression and OCD in the brainusing functional magnetic resonance imaging (fMRI). This approach will predict who willbenefit 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 andafter each treatment course to measure the effect of treatment on symptom severity and onfMRI measures of functional connectivity.Participants will be randomized to receive rTMS targeting either the lateral prefrontalcortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a5-day course of rTMS delivered hourly for 10 hours per day. Participants who show apartial response to treatment but not a full response will then receive a second 5-daycourse. Treatment non-responders will be crossed over to receive rTMS targeting theopposite brain area.The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement insymptoms for patients with depression and OCD in just 5 days, and that response rates canbe further improved by adding a second 5-day treatment course.
Device: MagVenture MagPro System with Brainsight neuronavigation device
10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten
minutes.
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
- Failed at least 1 prior trial of standard first-line treatment for depression or OCD
per the modified Antidepressant Treatment History form and APA Practice Guidelines
(e.g. serotonin reuptake inhibitor [SRI] or cognitive behavioral therapy with
exposure and response prevention) OR had refused these treatments for individual
reasons (e.g., cannot tolerate side effects, cannot tolerate exposure therapy,
etc.).
- 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 Note:
Medications that are known to increase cortical excitability (e.g., buprorion,
maprotiline, tricyclic antidepressants, classical antipsychotics) or to have an
inhibitory effect on brain excitability (e.g., anticonvulsants, benzodiazepines, and
atypical antipsychotics), or any other medications with relative hazard for use in
TMS will be allowed upon review of medications and/or motor threshold determination
by TMS specialist.
- 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 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)
- Current pregnancy or planning to conceive during the study
- Abnormal bloodwork for electrolytes, thyroid or liver function
Weill Cornell Medicine
New York, New York, United States
Investigator: Megan Johnson
Contact: 646-962-2900
tmsinfo@med.cornell.edu
Investigator: Conor Liston, MD, PhD
Megan Johnson
646-962-2900
tmsinfo@med.cornell.edu
Lindsay Victoria, PhD
liv3002@med.cornell.edu
Conor Liston, MD, PhD, Principal Investigator
Weill Medical College of Cornell University