Identifying brain markers to predict response to rTMS in OCD

Individualized Neuroimaging Biomarkers for Predicting Repetitive Transcranial Magnetic Stimulation (rTMS) Response in Obsessive Compulsive Disorder (OCD)

This study is trying to find out if brain scans can help predict how well different types of brain stimulation will work for people with OCD who haven’t had success with regular treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Stanford University (other)
• Locations: 1 site (Stanford, California)
• Trial ID: NCT05829681 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to discover brain-based subtypes of Obsessive Compulsive Disorder (OCD) and evaluate treatment responses to two different targets of repetitive transcranial magnetic stimulation (rTMS) in the brain. By utilizing MRI scans before and after rTMS treatment, the study seeks to define novel network-based subtypes of OCD, identify functional connectivity profiles that predict responses to either medial prefrontal cortex (MPFC) or right prefrontal cortex (rPFC) stimulation, and assess changes in resting-state functional connectivity associated with symptom improvement. The goal is to optimize treatment strategies for OCD patients who have not responded to standard care.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 with a moderate level of OCD severity who have not adequately responded to previous treatments.

Not a fit: Patients with mild OCD symptoms or those who have not tried any standard first-line treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment approaches for OCD, improving outcomes for patients who currently do not respond to standard 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 novel approach in OCD.

Eligibility criteria

Inclusion Criteria:

1. Outpatient
2. Aged 18-80
3. Either sex and all ethno-racial categories.
4. Meets 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 20.
5. Off antidepressants OR on a stable dose of SRI medication for at least 8 weeks prior to the study with plans to remain on this stable dose during the study.

   a. Medications that are known to increase cortical excitability (e.g., bupropion, 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.
6. Failed at least 1 prior trial of standard first-line OCD treatment per APA Practice Guidelines (serotonin reuptake inhibitor \[SRI\] or cognitive behavioral therapy with exposure and response prevention) OR had refused these treatments for individual reasons.
7. Capacity to provide informed consent.
8. Ability to tolerate clinical study procedures.
9. Successfully complete the MRI safety screening forms without any contraindications.

Exclusion Criteria:

1. Diagnosed according to the MINI as suffering from a primary psychiatric diagnosis other than OCD.
2. Evidence of psychotic symptoms on diagnostic interview.
3. Diagnosed according to the MINI as suffering from severe Personality Disorder (excluding Obsessive-Compulsive Personality Disorder) or hospitalized due to exacerbation related to borderline personality disorder.
4. Current bipolar disorder or history of any manic episodes.
5. Current active suicidality
6. Met criteria for moderate or severe Alcohol Use Disorder, Cannabis Use Disorder, or Substance Use Disorder (except nicotine and caffeine) within the past 3 months according to DSM-5 criteria.
7. Current eating disorder
8. 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.
9. Significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, history of cerebrovascular accident, transient ischemic attack within two years, cerebral aneurysm, dementia, Parkinson's disease, Huntington's chorea, multiple sclerosis, epilepsy.
10. Individuals with primary hoarding disorder without a DSM-5 OCD diagnosis (as determined by MINI and YBOCS checklist).
11. 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.
12. Pregnant or nursing females (assessed via urine dipstick), or plans to conceive during the study.
13. Positive urine screen for illicit drugs (assessed via urine dipstick) \[Exceptions: (1) any prescribed medication that participant is currently taking and (2) positive cocaine metabolite after consumption of coca tea\].
14. History of any implanted device or psychosurgery.
15. History of any metal in the head including the eyes and ears (outside the mouth).
16. Age of OCD symptom onset \> 40.
17. History of significant hearing loss.
18. Head or neck tics which interfere with TMS and/or MRI.
19. Subjects who suffered from an unstable physical, systemic and metabolic disorder such as unstabilized blood pressure or acute, unstable cardiac disease.
20. Autism spectrum disorder
21. aTBS treatment dose \> 65% maximum stimulator output (MSO)
22. Any other condition deemed by the PD to interfere with the study or increase risk to the participant

Where this trial is running

Stanford, California

• Stanford University — Stanford, California, United States (RECRUITING)

Study contacts

• Principal investigator: Nolan Williams, MD — Stanford University
• Study coordinator: Flint Espil, PhD

Conditions: Obsessive-Compulsive Disorder, rTMS, fMRI, EEG