rTMS for Obsessive-Compulsive Disorder

Recruiting at 1 trial location

Overseen By Nolan Williams, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must be taking: SRI medication

Disqualifiers: Psychotic symptoms, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore different brain-based subtypes of Obsessive-Compulsive Disorder (OCD) and assess their response to repetitive transcranial magnetic stimulation (rTMS). The research will test two brain areas: the medial prefrontal cortex and the right prefrontal cortex, to determine which is more effective. It targets individuals diagnosed with moderate OCD who have not found success with standard treatments, such as certain medications or therapy, and are not currently on medications that might interfere with brain activity. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for OCD.

Will I have to stop taking my current medications?

The trial requires that participants either be off antidepressants or on a stable dose of SRI medication for at least 8 weeks before the study and continue on this stable dose during the study. Other medications may be allowed after review by a TMS specialist.

What prior data suggests that rTMS is safe for treating OCD?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for treating conditions like OCD and depression. Studies have found that patients usually tolerate rTMS well, with most side effects being mild, such as headaches or scalp discomfort. Importantly, the FDA has approved rTMS for treating OCD, indicating a level of safety based on current evidence. This trial focuses on two specific brain areas: the medial prefrontal cortex (MPFC) and the right prefrontal cortex (rPFC). Previous research has not identified major safety concerns for these areas. Overall, the treatment is considered safe, with studies supporting its tolerability. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for Obsessive-Compulsive Disorder (OCD) involve medications like SSRIs or cognitive-behavioral therapy, which can take weeks or months to show results. However, repetitive Transcranial Magnetic Stimulation (rTMS) offers a different approach. This technique uses magnetic fields to stimulate specific brain areas, potentially providing quicker relief. In this trial, two variations are explored: Intermittent theta-burst stimulation (iTBS) targets the Medial Prefrontal Cortex for precise modulation, while continuous theta-burst stimulation (cTBS) focuses on the Right Prefrontal Cortex. Researchers are excited because these methods might offer faster and more targeted effects compared to traditional OCD treatments.

What evidence suggests that this trial's treatments could be effective for OCD?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can reduce symptoms of obsessive-compulsive disorder (OCD). A review of several studies found that rTMS is effective in various ways, with a moderate impact on lessening OCD symptoms. Studies also found that active rTMS outperforms a placebo in improving OCD symptoms. In this trial, participants will receive rTMS targeting specific brain areas. One group will receive stimulation of the medial prefrontal cortex (MPFC), while another group will receive stimulation of the right prefrontal cortex (rPFC). Both approaches have shown promising results in previous studies. Overall, rTMS could be a helpful treatment for people with OCD. ^{3 6 7 8 9}

Who Is on the Research Team?

Nolan Williams, MD

Principal Investigator

Stanford University

David Spiegel, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with Obsessive-Compulsive Disorder (OCD) who have a moderate severity score and have not responded to or refused standard treatments. Participants must be able to consent, may be on stable SRI medication, and complete MRI safety screening. Exclusions include primary psychiatric diagnoses other than OCD, severe personality disorders, active suicidality, metal in the body, unstable physical conditions, drug abuse, certain neurological disorders or history of seizures.

Inclusion Criteria

I understand and can agree to the study's procedures and risks.

I have been diagnosed with OCD and it's moderately severe.

Ability to tolerate clinical study procedures

Exclusion Criteria

Evidence of psychotic symptoms on diagnostic interview

Met criteria for moderate or severe Alcohol Use Disorder, Cannabis Use Disorder, or Substance Use Disorder within the past 3 months

I have had a device implanted or undergone brain surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rTMS treatment targeting either the MPFC or rPFC

4 weeks

Multiple visits for rTMS sessions

Follow-up

Participants are monitored for changes in OCD symptoms and resting-state functional connectivity

4 weeks

1 visit (in-person) for post-treatment assessment

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation
• rTMS

Trial Overview The study aims to identify brain-based subtypes of OCD and assess how well two different rTMS targets—the medial prefrontal cortex (MPFC) and the right prefrontal cortex (rPFC)—work in treating symptoms. It involves non-invasive magnetic stimulation of specific brain areas.

How Is the Trial Designed?

Group I: Medial Prefrontal Cortex (MPFC) Experimental Treatment 1 Intervention

Intermittent theta-burst stimulation (iTBS) of MPFC at up to 100% resting motor threshold (RMT), with lower extremity RMT established for the MPFC target.

Group II: Right Prefrontal Cortex (rPFC) Active Control 1 Intervention

Continuous theta-burst stimulation (cTBS) of rPFC at up to 110% of RMT, with upper extremity RMT established for the rPFC target.

Repetitive Transcranial Magnetic Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Migraines

Approved in European Union as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Anxiety disorders

Approved in Canada as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Foundation for OCD Research

Collaborator

Trials

2

Recruited

480+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

In a study of 50 SSRI-refractory OCD patients, 1 Hz rTMS over the supplementary motor area resulted in a 68% response rate, significantly higher than the 24% response rate in the usual treatment group with antipsychotics.

The rTMS treatment also led to a remission rate of 17.6%, suggesting that targeting the supplementary motor area could be a promising new approach for treating OCD in patients who do not respond to standard SSRIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better than treated as usual: Transcranial magnetic stimulation augmentation in selective serotonin reuptake inhibitor-refractory obsessive-compulsive disorder, mini-review and pilot open-label trial. Pallanti, S., Marras, A., Salerno, L., et al.[2022]

In a study involving 42 OCD patients, adjunctive high-frequency right prefrontal rTMS did not show significant efficacy in reducing obsessive-compulsive symptoms as measured by the Yale Brown Obsessive Compulsive Scale (YBOCS).

However, the treatment demonstrated modest effectiveness in alleviating comorbid depressive symptoms, as indicated by significant improvements in Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive high-frequency right prefrontal repetitive transcranial magnetic stimulation (rTMS) was not effective in obsessive-compulsive disorder but improved secondary depression. Sarkhel, S., Sinha, VK., Praharaj, SK.[2022]

In a randomized, double-blind trial involving 22 OCD patients, active repetitive transcranial magnetic stimulation (rTMS) to the supplementary motor area resulted in a 41% response rate, significantly higher than the 10% response rate for sham treatment.

Patients receiving active rTMS experienced an average 35% reduction in OCD symptoms, as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), compared to only a 6.2% reduction in the sham group, indicating the efficacy of rTMS in treating OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind trial of repetitive transcranial magnetic stimulation in obsessive-compulsive disorder with three-month follow-up. Gomes, PV., Brasil-Neto, JP., Allam, N., et al.[2012]

In a study of 12 patients with resistant OCD, repetitive transcranial magnetic stimulation (rTMS) led to significant improvements in obsessive thoughts and compulsive behaviors after 2 weeks, with effects lasting up to 1 month.

There was no significant difference in outcomes between right and left prefrontal rTMS, suggesting that either side may be effective, but further research is needed to confirm these findings and rule out placebo effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right versus left prefrontal transcranial magnetic stimulation for obsessive-compulsive disorder: a preliminary investigation. Sachdev, PS., McBride, R., Loo, CK., et al.[2019]

In a study of 63 obese individuals undergoing a 5-week rTMS treatment for weight control, the treatment showed a reassuring safety profile with no unexpected adverse events reported up to one year after treatment.

The most common side effects were moderate headaches (40.4%) and local pain/discomfort (19.2%), particularly more frequent in the high-frequency rTMS group, but overall, rTMS was well tolerated in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. Ferrulli, A., Massarini, S., Macrì, C., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) and its advanced form, deep transcranial magnetic stimulation (dTMS), are promising noninvasive treatments for obsessive-compulsive disorder (OCD), targeting specific brain areas to alleviate symptoms.

dTMS, which stimulates deeper brain structures than rTMS, represents a novel approach that may enhance treatment efficacy compared to traditional methods like medication and therapy, although the exact neurobiological mechanisms are still being studied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder: current perspectives. Lusicic, A., Schruers, KR., Pallanti, S., et al.[2020]

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool that can effectively treat clinical depression and potentially other brain disorders, but it carries risks, including the potential to induce seizures, as evidenced by 7 known cases by 1996.

A workshop established safety guidelines for rTMS, emphasizing the importance of monitoring, ethical considerations, and the expertise required for its administration to minimize risks and enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Wassermann, EM.[2022]

Repetitive transcranial magnetic stimulation (rTMS) significantly improves treatment-resistant depression, showing over three times higher odds of response compared to sham treatments, and nearly three times higher odds of achieving remission.

rTMS also effectively reduces symptoms of obsessive-compulsive disorder (OCD) and negative symptoms of schizophrenia, although it does not significantly impact auditory hallucinations, indicating varying efficacy based on the specific psychiatric condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depression, Schizophrenia, and Obsessive-Compulsive Disorder: An Umbrella Meta-Analysis. Patel, S., Silvi, S., Desai, S., et al.[2023]

Repetitive Transcranial Magnetic Stimulation (rTMS) has a good overall safety profile for treating depression, with common side effects like headaches being minor and manageable.

While there is a low incidence of serious side effects such as seizures and hypomania, these are linked to specific risk factors, suggesting that proper screening can enhance patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Loo, CK., McFarquhar, TF., Mitchell, PB.[2021]

In a double-blind study involving 18 subjects with treatment-resistant OCD, repetitive transcranial magnetic stimulation (rTMS) did not show significant efficacy compared to sham treatment after 10 sessions.

After extending to 20 sessions, rTMS resulted in a significant reduction in OCD symptoms, but this effect was not maintained when accounting for depression, indicating limited effectiveness for OCD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for the treatment of obsessive compulsive disorder: a double-blind controlled investigation. Sachdev, PS., Loo, CK., Mitchell, PB., et al.[2007]

Citations

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Efficacy and safety of accelerated transcranial magnetic ... Accelerated TMS offers promising, faster treatment for OCD and significantly reduces depressive symptoms, though it has no effect on anxiety.

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Transcranial magnetic stimulation The FDA also approved TMS for obsessive-compulsive disorder (OCD), migraines and to help people stop smoking when standard treatments haven't ...

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Efficacy and Safety of Deep Transcranial Magnetic ... High-frequency dTMS over the medial prefrontal cortex and anterior cingulate cortex significantly improved OCD symptoms and may be considered as a potential ...