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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)?

Research suggests that rTMS, a noninvasive treatment using magnetic fields to stimulate the brain, shows promise in treating OCD, especially when other treatments haven't worked. Some studies indicate it can be effective for certain OCD patients, but more research is needed to confirm these findings. ^{1 2 3 4 5}

Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for humans when used within recommended guidelines. Common side effects are usually minor, such as headaches, and the risk of seizures is low if proper precautions are taken. Safety guidelines have been established and updated over the years to ensure its safe application. ^{6 7 8 9 10}

How is the treatment rTMS different from other treatments for OCD?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it is a noninvasive treatment that uses magnetic fields to stimulate specific areas of the brain, offering a novel approach compared to traditional medication and therapy. It targets brain regions like the dorsolateral prefrontal cortex and supplementary motor area, potentially reducing OCD symptoms by altering brain activity. ^{2 3 4 5 11}

Research Team

Nolan Williams, MD

Principal Investigator

Stanford University

David Spiegel, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

My medication affecting brain activity is approved by a TMS specialist.

I have tried or refused standard OCD treatments.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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) 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) 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]

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 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]

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]

References

1. United States 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. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder: current perspectives. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Right versus left prefrontal transcranial magnetic stimulation for obsessive-compulsive disorder: a preliminary investigation. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for the treatment of obsessive compulsive disorder: a double-blind controlled investigation. [2007]

5. Netherlands 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Ireland 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. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind trial of repetitive transcranial magnetic stimulation in obsessive-compulsive disorder with three-month follow-up. [2012]