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Neuroimaging Biomarkers

Sponsor:

Stanford University

Code:

NCT05829681

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Repetitive Transcranial Magnetic Stimulation

Study Details

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

Study ID

NCT05829681

Start date

Mar 14, 2022

Status verified date

Nov, 2024

Completion date

Mar 14, 2029

Anticipated

Primary completion date

Mar 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

Repetitive 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.

Primary outcome measure

  • resting-state functional connectivity (rsFC) of frontostriatal networks [ Time Frame: pre-treatment up to 1-month post-treatment ]

Central Contacts and Locations

Central contacts

Jennifer Lissemore, PhD

jenliss@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94304

Contacts

More Information

Sponsor

Stanford University

Last update posted

Dec 2, 2024

Last verified

Nov, 2024

Keywords

  • rTMS
  • fMRI
  • EEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Stanford University on 2024-12-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.