Neuroimaging Biomarkers for Predicting rTMS Response in OCD

NCT04286126 | Unknown FDA Device

• 1 other identifier: 53879
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates an accelerated schedule of theta-burst stimulation using a Transcranial Magnetic Stimulation (TMS) device for treatment-resistant Obsessive Compulsive Disorder (OCD). In a randomized fashion, half the participants will receive accelerated theta-burst stimulation at the dorsomedial prefrontal cortex (DMPFC), while half will receive accelerated theta-burst stimulation at the right orbitofrontal (rOFC) site.

Conditions

Obsessive-Compulsive Disorder

Keywords

transcranial magnetic stimulation; theta burst

Outcome Measures

Primary Outcomes (1)

• Percentage change in Yale-Brown Obsessive-Compulsive Scale (YBOCS)

  The YBOCS is a 10-item clinician-rated questionnaire that assesses the impact and severity of an individual's obsessive thoughts and compulsive behaviors. The minimum and maximum scores are 0 and 36, respectively, with higher score indicating greater severity.

  Baseline (Pretreatment) to immediate post-treatment follow up

Secondary Outcomes (1)

• Percent change in the Obsessive-Compulsive Inventory-Revised (OCI-R)

  Baseline (Pretreatment) to immediate post-treatment follow up

Study Arms (2)

bilateral DMPFC

ACTIVE COMPARATOR

This arm will receive intermittent theta-burst stimulation to bilateral DMPFC site.

Device: Active bilateral DMPFC

right OFC

ACTIVE COMPARATOR

This arm will receive continuous theta-burst stimulation to the right OFC site.

Device: Active right-sided OFC

Interventions

Active bilateral DMPFC DEVICE

Participants in this arm will receive rTMS to bilateral DMPFC. The DMPFC will be targeted utilizing either Nexstim's eField neuronavigation system or Localite's neuronavigation system. Stimulation intensity will be standardized at 100% of resting motor threshold (RMT).

bilateral DMPFC

Active right-sided OFC DEVICE

Participants in this arm will receive rTMS to the right OFC. The right OFC will be targeted utilizing either Nexstim's eField neuronavigation system or Localite's neuronavigation system. Stimulation intensity will be standardized at 110% of resting motor threshold (RMT).

right OFC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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, maprotiline, tricyclic antidepressants, classical antipsychotics) or to have an inhibitory effect on brain excitability (e.g., anti-convulsants, 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 American Psychological Association (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 screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI) without any contraindications.

You may not qualify 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 \[Note: 17-item Hamilton Depression Rating Scale (HDRS-17) must be less or equal to 20 to enter study, assessed during baseline if last assessment was more than 1 week ago\]
• 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 Module E)
• 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), illness that caused brain injury or first degree relative with seizure disorder (assessed during screening via medical history assessment and TMS Safety Screen by study MD)
• 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 during baseline by study MD)
• 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) \[Exceptions: (1) any prescribed medication that participant is currently taking and (2) positive cocaine metabolite after consumption of coca tea\]
• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine

Stanford, California, 94305, United States

RECRUITING

Related Publications (16)

• George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.

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• George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008.

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• Chung SW, Hill AT, Rogasch NC, Hoy KE, Fitzgerald PB. Use of theta-burst stimulation in changing excitability of motor cortex: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2016 Apr;63:43-64. doi: 10.1016/j.neubiorev.2016.01.008. Epub 2016 Feb 3.

  PMID: 26850210 BACKGROUND

• Jelic MB, Milanovic SD, Filipovic SR. Differential effects of facilitatory and inhibitory theta burst stimulation of the primary motor cortex on motor learning. Clin Neurophysiol. 2015 May;126(5):1016-23. doi: 10.1016/j.clinph.2014.09.003. Epub 2014 Sep 16.

  PMID: 25281475 BACKGROUND

• Chung SW, Hoy KE, Fitzgerald PB. Theta-burst stimulation: a new form of TMS treatment for depression? Depress Anxiety. 2015 Mar;32(3):182-92. doi: 10.1002/da.22335. Epub 2014 Nov 28.

  PMID: 25450537 BACKGROUND

• Plewnia C, Pasqualetti P, Grosse S, Schlipf S, Wasserka B, Zwissler B, Fallgatter A. Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. J Affect Disord. 2014 Mar;156:219-23. doi: 10.1016/j.jad.2013.12.025. Epub 2013 Dec 28.

  PMID: 24411682 BACKGROUND

• Prasser J, Schecklmann M, Poeppl TB, Frank E, Kreuzer PM, Hajak G, Rupprecht R, Landgrebe M, Langguth B. Bilateral prefrontal rTMS and theta burst TMS as an add-on treatment for depression: a randomized placebo controlled trial. World J Biol Psychiatry. 2015 Jan;16(1):57-65. doi: 10.3109/15622975.2014.964768. Epub 2014 Nov 28.

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• Thut G, Pascual-Leone A. A review of combined TMS-EEG studies to characterize lasting effects of repetitive TMS and assess their usefulness in cognitive and clinical neuroscience. Brain Topogr. 2010 Jan;22(4):219-32. doi: 10.1007/s10548-009-0115-4. Epub 2009 Oct 28.

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• Holtzheimer PE 3rd, McDonald WM, Mufti M, Kelley ME, Quinn S, Corso G, Epstein CM. Accelerated repetitive transcranial magnetic stimulation for treatment-resistant depression. Depress Anxiety. 2010 Oct;27(10):960-3. doi: 10.1002/da.20731.

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• Fung PK, Robinson PA. Neural field theory of synaptic metaplasticity with applications to theta burst stimulation. J Theor Biol. 2014 Jan 7;340:164-76. doi: 10.1016/j.jtbi.2013.09.021. Epub 2013 Sep 21.

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• Biswal B, Yetkin FZ, Haughton VM, Hyde JS. Functional connectivity in the motor cortex of resting human brain using echo-planar MRI. Magn Reson Med. 1995 Oct;34(4):537-41. doi: 10.1002/mrm.1910340409.

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  PMID: 18403396 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Ian Kratter, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nick Bassano, MSW

CONTACT

650-497-3933; nbassano@stanford.edu

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: Clinical Assistant Professor, Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 26, 2020
• Study Start: January 15, 2021
• Primary Completion: July 15, 2025
• Study Completion: December 15, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)