180 Participants Needed

Accelerated Theta-Burst Stimulation for Obsessive-Compulsive Disorder

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RN
NB
Overseen ByNick Bassano, MSW
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
Must be taking: Serotonin reuptake inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to be stable on Serotonin Re-uptake Inhibitor (SRI) medication for at least 8 weeks before and throughout the study. Other medications may be allowed after review by a TMS specialist.

What data supports the effectiveness of this treatment for obsessive-compulsive disorder?

Research shows that continuous theta burst stimulation (cTBS) targeting specific brain areas like the orbitofrontal cortex (OFC) and supplementary motor area (SMA) can help reduce symptoms of obsessive-compulsive disorder (OCD), especially in patients who haven't responded to other treatments. Studies found improvements in anxiety and overall severity of OCD symptoms, suggesting this treatment may be beneficial.12345

Is theta-burst stimulation (TBS) generally safe for humans?

Theta-burst stimulation (TBS), a type of transcranial magnetic stimulation, has been studied for various conditions like depression and addiction. Research shows it generally has mild side effects and no serious issues like seizures or mania have been reported, indicating it is generally safe for humans.678910

How does the treatment Accelerated Theta-Burst Stimulation for Obsessive-Compulsive Disorder differ from other treatments?

Accelerated Theta-Burst Stimulation (TBS) is a unique treatment for Obsessive-Compulsive Disorder (OCD) because it uses magnetic pulses to non-invasively target specific brain areas, like the orbitofrontal cortex and supplementary motor area, which are involved in OCD symptoms. This approach is different from traditional treatments like medication and psychotherapy, as it directly modulates brain activity and is particularly promising for patients who do not respond to standard treatments.12345

Research Team

IK

Ian Kratter, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults with moderate to severe OCD who haven't responded well to standard treatments like SRIs or cognitive behavioral therapy. Participants must be stable on SRI medication for at least 8 weeks and able to undergo study procedures. Excluded are those with substance abuse issues, severe depression, bipolar disorder, eating disorders, certain medical conditions like seizures or brain injuries, pregnant or nursing women, and anyone planning CBT during the study.

Inclusion Criteria

I have been taking the same SRI medication for at least 8 weeks and plan to continue during the study.
I understand and can agree to the study's procedures and risks.
Successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI) without any contraindications
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Exclusion Criteria

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)
Pregnant or nursing females (assessed via urine dipstick if screening appointment was more than 30 days ago)
I do not have an eating disorder.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated theta-burst stimulation using a TMS device targeting either the DMPFC or rOFC site

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Immediate post-treatment

Treatment Details

Interventions

  • Active bilateral DMPFC
  • Active right-sided OFC
Trial OverviewThe trial tests an accelerated form of Transcranial Magnetic Stimulation (TMS) called theta-burst stimulation in two different brain areas: the dorsomedial prefrontal cortex (DMPFC) and the right orbitofrontal cortex (rOFC). Participants will be randomly assigned to receive treatment at one of these sites.
Participant Groups
2Treatment groups
Active Control
Group I: right OFCActive Control1 Intervention
This arm will receive continuous theta-burst stimulation to the right OFC site.
Group II: bilateral DMPFCActive Control1 Intervention
This arm will receive intermittent theta-burst stimulation to bilateral DMPFC site.

Active bilateral DMPFC is already approved in United States for the following indications:

🇺🇸
Approved in United States as BrainsWay Deep TMS for:
  • Obsessive Compulsive Disorder (OCD)
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Approved in United States as MagVenture TMS for:
  • Obsessive Compulsive Disorder (OCD)
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Approved in United States as NeuroStar TMS for:
  • Obsessive Compulsive Disorder (OCD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Findings from Research

In a pilot study involving 29 OCD patients, continuous theta burst stimulation (cTBS) targeting the bilateral supplementary motor area significantly relieved OCD symptoms in 37.93% of participants, indicating its potential efficacy as a treatment.
The study found that functional connectivity between specific brain regions could predict the effectiveness of cTBS, with a high area under the curve (AUC) of 0.85, suggesting that neuroimaging may help identify which patients are more likely to benefit from this intervention.
The functional connectivity predictor of therapeutic effect of continuous theta burst stimulation on obsessive-compulsive disorder: A preliminary study.Li, P., Cheng, J., Fan, Q., et al.[2022]
In a study involving 33 OCD patients, continuous Theta Burst Stimulation (cTBS) targeting the orbitofrontal cortex (OFC) was found to be well tolerated and led to significant improvements in anxiety symptoms and overall severity of OCD after 10 treatment sessions.
While the treatment showed a notable effect on anxiety and global severity scores, the improvements in obsessive and compulsive symptoms were not statistically significant when controlling for other variables, suggesting that the primary benefit of cTBS may be in reducing anxiety associated with OCD.
Efficacy of intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS) in Obsessive Compulsive Disorder: A Randomized Placebo Controlled Study.Dutta, P., Dhyani, M., Garg, S., et al.[2021]
A retrospective analysis of six patients with treatment-resistant OCD showed that continuous theta burst stimulation (cTBS) targeting the supplementary motor cortex may help reduce obsessive-compulsive symptoms, suggesting a potential new treatment avenue.
Despite the promising results, the study highlights the need for further research through randomized, sham-controlled trials with larger participant groups to validate the efficacy of cTBS for OCD.
A Case Series of Continuous Theta Burst Stimulation Treatment for the Supplementary Motor Area Twice a Day in Patients with Obsessive-Compulsive Disorder: A Real World TMS Registry Study in Japan.Noda, Y., Fujii, K., Tokura, F., et al.[2023]

References

The functional connectivity predictor of therapeutic effect of continuous theta burst stimulation on obsessive-compulsive disorder: A preliminary study. [2022]
Efficacy of intensive orbitofrontal continuous Theta Burst Stimulation (iOFcTBS) in Obsessive Compulsive Disorder: A Randomized Placebo Controlled Study. [2021]
A Case Series of Continuous Theta Burst Stimulation Treatment for the Supplementary Motor Area Twice a Day in Patients with Obsessive-Compulsive Disorder: A Real World TMS Registry Study in Japan. [2023]
Continuous theta burst stimulation over the supplementary motor area in refractory obsessive-compulsive disorder treatment: A randomized sham-controlled trial. [2020]
Continuous Theta-Burst Stimulation Over the Right Orbitofrontal Cortex in Treatment-Resistant Obsessive-Compulsive Disorder Treatment: A Randomized Sham-Controlled Trial. [2022]
Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. [2022]
Intermittent Theta Burst Stimulation of the Prefrontal Cortex in Cocaine Use Disorder: A Pilot Study. [2020]
Safety and Efficacy of Theta-Burst Stimulation in the Treatment of Psychiatric Disorders: A Review of the Literature. [2019]
A systematic review of the neurobiological effects of theta-burst stimulation (TBS) as measured using functional magnetic resonance imaging (fMRI). [2023]
Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. [2018]