Obsessive-Compulsive Disorder study: Active bilateral DMPFC vs Active right-sided OFC
Official title Neuroimaging Biomarkers for Predicting rTMS Response in OCD
ClinicalTrials.gov ID: NCT04286126
What this study is testing
- What it's testing
- The study compares two brain targets for rapid‑pulse TMS to see which better helps people with OCD who haven’t improved with other treatments.
- Who it's for
- Adults who have OCD that has not responded to other therapies.
- What's involved
- Participants will receive TMS sessions at either the dorsomedial prefrontal cortex or the right orbitofrontal cortex, chosen randomly.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- stable on Serotonin Re-uptake Inhibitor (SRI) medication for at least 8 weeks prior to (with plans to continue throughout) the study Note...
- failed at least 1 prior trial of standard first-line OCD treatment per American Psychological Association (APA) Practice Guidelines (serotonin...
- capacity to provide informed consent.
- ability to tolerate clinical study procedures.
You likely can't join if
- Current psychosis (re-assessed only if screening appointment was more than 30 days ago - Structured Clinical Interview for DSM-IV (SCID) - 5 Module B)
- Current bipolar disorder (assessed during baseline if screening appointment was more than 30 days ago - SCID-5 Module D)
- 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...
- Current active suicidality (as determined by C-SSRS at baseline of 3 or above)
- Current moderate or severe Alcohol Usage Disorder or Substance Usage Disorder (except nicotine and caffeine) according to the DSM-5 criteria...
- Current eating disorder (assessed during baseline if screening appointment was more than 3 months ago - SCID-5 Module I)
See the full eligibility criteria
- 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.
- 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...
- 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...
- capacity to provide informed consent.
- ability to tolerate clinical study procedures.
- successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI) without any contraindications.
- Current psychosis (re-assessed only if screening appointment was more than 30 days ago - Structured Clinical Interview for DSM-IV (SCID) - 5 Module B)
- Current bipolar disorder (assessed during baseline if screening appointment was more than 30 days ago - SCID-5 Module D)
- 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]
- Current active suicidality (as determined by C-SSRS at baseline of 3 or above)
- 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...
- Current eating disorder (assessed during baseline if screening appointment was more than 3 months ago - SCID-5 Module I)
- 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)...
- 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)
- 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...
- Pregnant or nursing females (assessed via urine dipstick if screening appointment was more than 30 days ago)
- 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...
- History of any implanted device or psychosurgery (assessed during baseline by study MD)
- History of receiving Electroconvulsive Therapy (ECT) (assessed during baseline by study MD)
- Age of OCD symptom onset \>30
The study team makes the final eligibility decision.
Where it is enrolling
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Stanford, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.