Using brain imaging to predict response to TMS in OCD treatment
Official title: Individualized Neuroimaging Biomarkers for Predicting rTMS Response in OCD
Run by Stanford University · NCT04286126 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Status | Recruiting |
| Started | January 15, 2021 |
| Main results expected | July 15, 2025 |
| Study ends | December 15, 2025 |
| Registry record updated | April 18, 2023 |
| Trial ID | NCT04286126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with moderate OCD who have not responded adequately to at least one prior standard treatment.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using neuroimaging to predict treatment responses in various psychiatric conditions, suggesting potential success for this approach in OCD.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: nbassano@stanford.edu
- Phone: 650-497-3933
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Low-intensity focused ultrasound targeting the subthalamic nucleus for OCD
A short test is being done to see if a wearable, non-invasive ultrasound device can safely and tolerably help adults with OCD by targeting a brain region called the subthalamic nucleus.
-
Mindfulness-Based Cognitive Therapy for OCD Delivered Online
This study tests a synchronous online MBCT program for adults with OCD to see if it is acceptable and feasible and to explore links between biological markers, OCD severity, and treatment response.
-
Targeted brain stimulation for OCD: test of tTIS on nucleus accumbens
This study tests whether targeted temporal interference stimulation of the nucleus accumbens can help reduce obsessive-compulsive symptoms in adults with OCD, compared with sham stimulation.
-
Anxiety Skills Study: See if video skill training plus therapy helps people with anxiety
This study tests whether a brief video-based skill training can help people with anxiety as well as four therapy sessions, and how durable the effects are over a year.
-
AttunE LIFU for OCD: a non-invasive brain stimulation study
This trial tests ATTN201, a wearable ultrasound headband, to see if it helps adults with OCD compared to a sham treatment.
-
Combined ERP and Habit Reversal Therapy for Tourettic OCD
This study tests whether a merged Exposure and Response Prevention and Habit Reversal Therapy helps adults with Tourettic OCD more than either therapy alone or basic psychoeducation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.