Obsessive-Compulsive DisorderNCT05829681
Individualized Neuroimaging Biomarkers for Predicting rTMS Response in OCD
A study testing Repetitive Transcranial Magnetic Stimulation in people with Obsessive-Compulsive Disorder, run by Stanford University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 14 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient
- Aged 18-80
- Either sex and all ethno-racial categories.
- 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.
- 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.
- 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.
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- 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.
- Capacity to provide informed consent.
- Ability to tolerate clinical study procedures.
- Successfully complete the MRI safety screening forms without any contraindications.
Who cannot join
- Diagnosed according to the MINI as suffering from a primary psychiatric diagnosis other than OCD.
- Evidence of psychotic symptoms on diagnostic interview.
- 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.
- Current bipolar disorder or history of any manic episodes.
- Current active suicidality
- 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.
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- Current eating disorder
- 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.
- 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.
- Individuals with primary hoarding disorder without a DSM-5 OCD diagnosis (as determined by MINI and YBOCS checklist).
- 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.
- Pregnant or nursing females (assessed via urine dipstick), or plans to conceive during the study.
- 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].
- History of any implanted device or psychosurgery.
- History of any metal in the head including the eyes and ears (outside the mouth).
- Age of OCD symptom onset > 40.
- History of significant hearing loss.
- Head or neck tics which interfere with TMS and/or MRI.
- Subjects who suffered from an unstable physical, systemic and metabolic disorder such as unstabilized blood pressure or acute, unstable cardiac disease.
- Autism spectrum disorder
- aTBS treatment dose > 65% maximum stimulator output (MSO)
- Any other condition deemed by the PD to interfere with the study or increase risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Neuroimaging Biomarkers for Predicting Repetitive Transcranial Magnetic Stimulation (rTMS) Response in Obsessive Compulsive Disorder (OCD)
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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- rTMS, fMRI, EEG
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called rTMS, MagVenture MagPro rTMS Research System
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.
| Study group | Role | What they receive |
|---|---|---|
| Medial Prefrontal Cortex (MPFC) | Experimental | Intermittent theta-burst stimulation (iTBS) of MPFC at up to 100% resting motor threshold (RMT), with lower extremity RMT established for the MPFC target. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Right Prefrontal Cortex (rPFC) | Active comparator | Continuous theta-burst stimulation (cTBS) of rPFC at up to 110% of RMT, with upper extremity RMT established for the rPFC target. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: pre-treatment to 1-week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start14 Mar 2022
- Primary completion14 Mar 2027 (estimated)
- Study completion14 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Foundation for OCD Research
- Responsible party
- Principal investigator, David Spiegel, Stanford University
- Investigators
- David Spiegel, MD, Study director, Stanford UniversityNolan Williams, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829681
- Sponsor's protocol ID
- 62822
- Other IDs
- 22-03024635, Pro00057331
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Neuroimaging Biomarkers for Predicting Repetitive Transcranial Magnetic Stimulation (rTMS) Response in Obsessive Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT05829681
- Acronym / sponsor ID
- 62822
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- rTMS, fMRI, EEG
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Cornell University, Foundation for OCD Research
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 14 Mar 2029 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medial Prefrontal Cortex (MPFC) | Experimental | Device: Repetitive Transcranial Magnetic StimulationIntermittent theta-burst stimulation (iTBS) of MPFC at up to 100% resting motor threshold (RMT), with lower extremity RMT established for the MPFC target. |
| Right Prefrontal Cortex (rPFC) | Active comparator | Device: Repetitive Transcranial Magnetic StimulationContinuous theta-burst stimulation (cTBS) of rPFC at up to 110% of RMT, with upper extremity RMT established for the rPFC target. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Outpatient
- Aged 18-80
- Either sex and all ethno-racial categories.
- 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.
- 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.
Key exclusion criteria (22 listed)
- Diagnosed according to the MINI as suffering from a primary psychiatric diagnosis other than OCD.
- Evidence of psychotic symptoms on diagnostic interview.
- 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.
- Current bipolar disorder or history of any manic episodes.
- Current active suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: rTMS, MagVenture MagPro rTMS Research SystemParticipants 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. | Device | Medial Prefrontal Cortex (MPFC), Right Prefrontal Cortex (rPFC) |
Primary outcome
resting-state functional connectivity (rsFC) of frontostriatal networks
Time frame: pre-treatment up to 1-month post-treatment
functional magnetic resonance imaging (fMRI) measures of resting-state functional connectivity (rsFC) in the frontostriatal networks targeted by rTMS (MPFC or rPFC)
1 secondary outcome
OCD symptoms
Time frame: pre-treatment to 1-week post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Spiegel, MD study director
Stanford University
Nolan Williams, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Obsessive-Compulsive Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting-state functional connectivity (rsFC) of frontostriatal networks (time frame: pre-treatment up to 1-month post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.