Using brain imaging to predict response to TMS in OCD treatment

Individualized Neuroimaging Biomarkers for Predicting rTMS Response in OCD

This study is testing if brain scans can help predict how well a new type of brain stimulation treatment will work for people with OCD who haven't found relief from other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Stanford, California)
• Trial ID: NCT04286126 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of an accelerated schedule of theta-burst stimulation using a Transcranial Magnetic Stimulation (TMS) device for patients with treatment-resistant Obsessive Compulsive Disorder (OCD). Participants will be randomly assigned to receive stimulation at either the dorsomedial prefrontal cortex (DMPFC) or the right orbitofrontal cortex (rOFC). The study aims to identify neuroimaging biomarkers that can predict individual responses to TMS, enhancing treatment personalization. By leveraging advanced neurophysiological methods, the researchers hope to improve the accuracy of predicting which patients will benefit from TMS based on their brain connectivity patterns.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with moderate OCD who have not responded adequately to at least one prior standard treatment.

Not a fit: Patients who have not been stable on SRI medication for at least 8 weeks or those with specific contraindicated medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with OCD who do not respond to conventional therapies.

How similar studies have performed: Other studies have shown promise in using neuroimaging to predict treatment responses in various psychiatric conditions, suggesting potential success for this approach in OCD.

Eligibility criteria

Inclusion Criteria:

1. meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OCD with a moderate level of severity as defined by a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 18.
2. stable on Serotonin Re-uptake Inhibitor (SRI) medication for at least 8 weeks prior to (with plans to continue throughout) 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., anti-convulsants, 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.
3. failed at least 1 prior trial of standard first-line OCD treatment per American Psychological Association (APA) Practice Guidelines (serotonin reuptake inhibitor \[SRI\] or cognitive behavioral therapy with exposure and response prevention)OR had refused these treatments for individual reasons.
4. capacity to provide informed consent.
5. ability to tolerate clinical study procedures.
6. successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI) without any contraindications.

Exclusion Criteria:

1. Current psychosis (re-assessed only if screening appointment was more than 30 days ago - Structured Clinical Interview for DSM-IV (SCID) - 5 Module B)
2. Current bipolar disorder (assessed during baseline if screening appointment was more than 30 days ago - SCID-5 Module D)
3. Severe depression \[Note: 17-item Hamilton Depression Rating Scale (HDRS-17) must be less or equal to 20 to enter study, assessed during baseline if last assessment was more than 1 week ago\]
4. Current active suicidality (as determined by C-SSRS at baseline of 3 or above)
5. Current moderate or severe Alcohol Usage Disorder or Substance Usage Disorder (except nicotine and caffeine) according to the DSM-5 criteria (assessed only if screening appointment was more than 12 months ago - SCID-5 Module E)
6. Current eating disorder (assessed during baseline if screening appointment was more than 3 months ago - SCID-5 Module I)
7. History of seizure, having an EEG, stroke, head injury (including neurosurgery), implanted devices, frequent or severe headaches, brain related conditions (e.g., intracranial mass lesions globe injuries, hydrocephalus), illness that caused brain injury or first degree relative with seizure disorder (assessed during screening via medical history assessment and TMS Safety Screen by study MD)
8. Individuals with primary hoarding disorder without a DSM-5 OCD diagnosis (as determined by SCID-5 and YBOCS checklist assessed only if screening appointment was more than 30 days ago)
9. Planning to commence Cognitive Behavioral Therapy (that includes exposure and response prevention) during the period of the study or have begun Cognitive Behavioral Therapy within 8 weeks prior to enrollment (assessed during baseline by study MD)
10. Pregnant or nursing females (assessed via urine dipstick if screening appointment was more than 30 days ago)
11. Positive urine screen for illicit drugs (assessed via urine dipstick if screening appointment was more than 30 days ago) \[Exceptions: (1) any prescribed medication that participant is currently taking and (2) positive cocaine metabolite after consumption of coca tea\]
12. History of any implanted device or psychosurgery (assessed during baseline by study MD)
13. History of receiving Electroconvulsive Therapy (ECT) (assessed during baseline by study MD)
14. Age of OCD symptom onset \>30

Where this trial is running

Stanford, California

• Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine — Stanford, California, United States (Recruiting)

Study contacts

• Principal investigator: Ian Kratter, MD, PhD — Stanford University
• Study coordinator: Nick Bassano, MSW

Conditions Obsessive-Compulsive Disorder; transcranial magnetic stimulation; theta burst