Individualized Neuroimaging Biomarkers for Predicting rTMS Response in OCD

NCT05829681 | Active Not Recruiting DMC FDA Device

• 3 other identifiers: 6282222-03024635Pro00057331
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obsessive-Compulsive Disorder

Keywords

rTMS; fMRI; EEG

Outcome Measures

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)

  pre-treatment up to 1-month post-treatment

Secondary Outcomes (1)

• OCD symptoms

  pre-treatment to 1-week post-treatment

Study Arms (2)

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.

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.

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

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

Medial Prefrontal Cortex (MPFC); Right Prefrontal Cortex (rPFC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Stanford University: lead
• Cornell University: collaborator
• Foundation for OCD Research: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• David Spiegel, MD

  Stanford University

  STUDY DIRECTOR

• Nolan Williams, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jack, Lulu and Sam Willson Professor of Medicine

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 26, 2023
• Study Start: March 14, 2022
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): March 14, 2029
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Deidentified data will be available any time following publication of outcomes from this study, with no specified end date.
• Access Criteria: Deidentified data will be shared with any researcher requesting access.

Locations

US (1)