CClinicalTrials.gg
Active, not recruitingNCT05829681Updated Dec 10, 2025

Individualized Neuroimaging Biomarkers for Predicting rTMS Response in OCD

An interventional study of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder, sponsored by Stanford University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2022, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The goal of this clinical trial is to discover brain-based subtypes of Obsessive Compulsive Disorder (OCD) and examine treatment response to two different repetitive transcranial magnetic stimulation (rTMS) targets in the brain: the medial prefrontal cortex (MPFC) and the right prefrontal cortex (rPFC).

Read the detailed description

New interventions are urgently needed to treat obsessive compulsive disorder (OCD), as more than 25% of patients show no improvement with the standard of care. Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative treatment, as it uses focused magnetic field pulses to stimulate specific brain areas. So far, medial and right prefrontal cortex stimulation targets have consistent evidence of efficacy in OCD. Patients often show a strong response to one target but not the other. It is not well understood why some patients respond, while others do not. So far, there are no biomarkers for predicting treatment response, identifying the optimal neuroanatomical target, or choosing between treatments.

The goal of this clinical trial is OCD subtype discovery and treatment optimization. Using MRI scans of OCD patients before and after rTMS treatment we aim to:

  • Define novel network-based subtypes of OCD that can be diagnosed in individual patients and differentiated from healthy controls;
  • Identify characteristic functional connectivity profiles predictive of response to MPFC-rTMS versus rPFC-rTMS;
  • Identify characteristic changes in resting-state functional connectivity (RSFC) associated with symptom improvement for OCD patients undergoing MPFC- and rPFC-rTMS.
02

Conditions studied

  • Obsessive-Compulsive Disorder

Keywords

  • rTMS
  • fMRI
  • EEG
03

In context

Obsessive-Compulsive Disorder

606 studies on the registry are indexed under Obsessive-Compulsive Disorder; 160 are open to participants now.

This study's enrollment of 212 is above the median of 45 across 492 interventional studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
212 participants (actual)

Study arms

  • Experimental
    Medial Prefrontal Cortex (MPFC)

    Intermittent theta-burst stimulation (iTBS) of MPFC at up to 100% resting motor threshold (RMT), with lower extremity RMT established for the MPFC target.

    Device: Repetitive Transcranial Magnetic Stimulation

  • Active comparator
    Right Prefrontal Cortex (rPFC)

    Continuous theta-burst stimulation (cTBS) of rPFC at up to 110% of RMT, with upper extremity RMT established for the rPFC target.

    Device: Repetitive Transcranial Magnetic Stimulation

Interventions

  • DeviceRepetitive Transcranial Magnetic Stimulation

    Participants will receive a 5-day course of 10x daily rTMS, with sessions delivered hourly. Each session will deliver up to 1800 pulses of theta-burst stimulation per target.

    Also known as: rTMS, MagVenture MagPro rTMS Research System

06

What researchers measure

Primary outcomes

  1. resting-state functional connectivity (rsFC) of frontostriatal networks

    functional magnetic resonance imaging (fMRI) measures of resting-state functional connectivity (rsFC) in the frontostriatal networks targeted by rTMS (MPFC or rPFC)

    Time frame: pre-treatment up to 1-month post-treatment

Secondary outcomes

  1. OCD symptoms

    Change in OCD symptoms (YBOCS 2, Yale-Brown Obsessive Compulsive Scale 2, score range: 0-50, higher scores indicating higher symptom levels) following treatment with rTMS

    Time frame: pre-treatment to 1-week post-treatment

07

Study locations

1 site
  • Stanford University
    Stanford, California 94304, United States
08

References and documents

Individual participant data

Plan to share: Yes — The project will implement open data dissemination to ensure that the other FFOR teams and subsequently the wider research community will have ready access to the acquired data, including clinical and neuroimaging data from patients before and after treatment. To this end, all consent forms and datasharing agreements across the recruiting sites will incorporate content to enable this open data-sharing.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05829681
Lead sponsor
Stanford University
Collaborators
Cornell University, Foundation for OCD Research
Responsible party
David Spiegel (Jack, Lulu and Sam Willson Professor of Medicine, Stanford University) — Principal investigator
First posted
Apr 26, 2023
Start date
Mar 14, 2022
Primary completion
Mar 14, 2027 (estimated)
Completion
Mar 14, 2029 (estimated)
Last update
Dec 10, 2025

Study contacts

David Spiegel, MD
study director · Stanford University
Nolan Williams, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion