rTMS + Cognitive Behavioural Therapy for Obsessive-Compulsive Disorder

Overseen By Kailee Kassardjian

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: OCD medications

Disqualifiers: Severe mood disorder, Schizophrenia, Substance abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Cognitive behavioural therapy (CBT), incorporating exposure/response prevention (ERP) and cognitive therapy, is considered the gold-standard first-line treatment for obsessive-compulsive disorder (OCD). Because CBT is a psychological treatment that aims to change patterns of thinking and behaving, it may be that improvement in cognitive functioning before treatment starts could lead CBT to be even more effective. One area of research that has shown potential benefit for OCD sufferers is rTMS. rTMS is a non-invasive procedure that uses pulses of energy to stimulate regions of the brain. Brief treatment with rTMS has shown to improve attention, memory, and other aspects of cognitive functioning that may facilitate learning in CBT. The proposed study aims to provide a pilot test of the clinical effectiveness of adding brief rTMS prior to completing CBT for OCD. If rTMS can demonstrate enhancement of cognitive functioning, which in turn, can improve treatment response to CBT, then the findings could easily be translated into routine clinical care.

Will I have to stop taking my current medications?

If you are taking medications for OCD, you must be on a stable dose for at least 8 weeks before starting the study. The protocol does not specify if you need to stop other medications, so it's best to discuss this with the study team.

What data supports the effectiveness of the treatment rTMS for Obsessive-Compulsive Disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can be effective in reducing symptoms of obsessive-compulsive disorder (OCD), as well as associated anxiety and depression. Studies have demonstrated its safety and short-term benefits, particularly in severe cases of OCD. ^{1 2 3 4 5}

Is rTMS safe for treating OCD?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for treating obsessive-compulsive disorder (OCD), with no serious side effects reported, although some people may experience mild headaches. ^{1 2 6 7 8}

How does the rTMS + Cognitive Behavioural Therapy treatment for OCD differ from other treatments?

This treatment combines repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate specific brain areas, with cognitive behavioral therapy (CBT), a type of talk therapy. This combination is unique because rTMS targets brain activity directly, potentially enhancing the effects of CBT, especially for patients who do not respond well to standard treatments. ^{1 2 5 8 9}

Research Team

Peter Giacobbe, M.D.

Principal Investigator

Sunnybrook Health Sciences Centre

Neil A. Rector, Ph.D.

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

This trial is for individuals with Obsessive-Compulsive Disorder (OCD) who are seeking treatment. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

My OCD medication dose has been stable for at least 8 weeks.

I am between 18 and 65 years old.

Experiencing clinically significant obsessive-compulsive symptoms based on the Yale-Brown Obsessive Compulsive Scale (YBOCS; score > 16)

Exclusion Criteria

I might have a disease caused by physical or bodily changes.

Concurrent diagnosis of a severe mood disorder, schizophrenia or other psychotic disorders, or substance abuse/dependence

I have a health condition that might need urgent care during treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

rTMS Treatment

Participants receive 10 sessions of rTMS treatment Monday through Friday for two weeks

2 weeks

10 visits (in-person)

CBT Treatment

Participants receive 12 weeks of cognitive behavioural therapy (CBT)

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• rTMS (Procedure)

Trial Overview The trial is testing whether using rTMS, a non-invasive brain stimulation technique, before Cognitive Behavioural Therapy (CBT) can improve outcomes for OCD patients. It explores if enhancing cognitive functions with rTMS leads to better CBT results.

Participant Groups

Group I: Brief rTMS + Group CBT Experimental Treatment 2 Interventions

Participants in this study arm will receive 10 sessions of rTMS treatment Monday through Friday for two weeks. Following rTMS treatment, participants will receive 12 weeks of CBT.

Group II: Group CBT only Active Control 1 Intervention

Participants in this study arm will receive 12 weeks of CBT

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Findings from Research

Repetitive transcranial magnetic stimulation (rTMS) shows promising efficacy in treating severe, resistant obsessive-compulsive disorder (OCD), particularly when targeting the supplementary motor area and the orbitofrontal cortex, based on a review of 12 studies.

However, rTMS targeting the dorsolateral prefrontal cortex did not demonstrate significant effectiveness compared to sham treatments, indicating that not all stimulation sites are beneficial for OCD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of repetitive transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder: a review. Jaafari, N., Rachid, F., Rotge, JY., et al.[2012]

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]

Repeated transcranial magnetic stimulation (rTMS) demonstrated a large therapeutic effect in treating obsessive-compulsive disorder (OCD), with an effect size of 0.71 based on a review of 20 studies involving 791 patients.

The effectiveness of rTMS varied based on the targeted brain area, with the right dorsolateral prefrontal cortex showing the highest effect size (0.93), and both low-frequency and high-frequency treatments were effective, indicating that rTMS can be a promising short-term treatment for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated meta-analysis: Short-term therapeutic effects of repeated transcranial magnetic stimulation in treating obsessive-compulsive disorder. Zhou, DD., Wang, W., Wang, GM., et al.[2022]

In a study involving 18 sessions of repetitive transcranial magnetic stimulation (rTMS) on patients with obsessive-compulsive disorder (OCD), no significant improvements were observed in OCD symptoms compared to a sham treatment group.

Both the real rTMS and sham conditions showed similar outcomes, indicating that low-frequency rTMS of the right prefrontal cortex may not be an effective treatment for OCD, suggesting the need for further research to explore optimal stimulation parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right prefrontal repetitive transcranial magnetic stimulation in obsessive-compulsive disorder: a double-blind, placebo-controlled study. Alonso, P., Pujol, J., Cardoner, N., et al.[2006]

Repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (DLPFC) has been shown to effectively reduce symptoms of anxiety and depression in patients with obsessive-compulsive disorder (OCD), based on a meta-analysis of 20 studies involving 688 participants.

While rTMS demonstrated a small to medium effect on reducing OCD, anxiety, and depression symptoms, the improvement in anxiety was influenced by changes in OCD severity, indicating a complex relationship between these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Repetitive Transcranial Magnetic Stimulation on Comorbid Anxiety and Depression Symptoms in Obsessive-Compulsive Disorder: A Meta-Analysis of Randomized Sham-Controlled Trials. Thatikonda, NS., Vinod, P., Balachander, S., et al.[2023]

In a study involving 20 patients with treatment-resistant obsessive-compulsive disorder, sequential low-frequency rTMS targeting the right dorsolateral prefrontal cortex and supplementary motor area showed no significant therapeutic effect compared to sham treatment over 10 sessions.

Despite the lack of efficacy in reducing obsessive-compulsive symptoms, rTMS was found to be a safe treatment method, with no significant changes in cognitive function observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled study of sequentially applied repetitive transcranial magnetic stimulation in obsessive-compulsive disorder. Kang, JI., Kim, CH., Namkoong, K., et al.[2019]

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]

In a study of 16 patients with treatment-resistant OCD, 16 sessions of low-frequency rTMS on the Supplementary Motor Area significantly reduced symptoms of OCD, anxiety, and depression, as measured by standardized scales.

The treatment was well-tolerated, with no serious side effects reported, although two patients experienced mild headaches, indicating that rTMS could be a safe option for patients who do not respond to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive- Compulsive Disorder. Hashempour, S., Ansari, S., Arbabi, M., et al.[2022]

In a study involving 61 treatment-refractory OCD patients, all three rTMS protocols combined with exposure and response prevention (ERP) led to significant reductions in OCD symptoms, with a response rate of 57.4%.

Both high-frequency rTMS to the left dorsolateral prefrontal cortex and the left pre-supplementary motor area resulted in decreased activation in brain areas related to planning and error processing, which correlated with symptom improvement, although no significant differences in symptom reduction were found between the different rTMS groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TMS-induced plasticity improving cognitive control in OCD I: Clinical and neuroimaging outcomes from a randomised trial of rTMS for OCD. Fitzsimmons, SMDD., Postma, T., van Campen, AD., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of repetitive transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder: a review. [2012]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

An updated meta-analysis: Short-term therapeutic effects of repeated transcranial magnetic stimulation in treating obsessive-compulsive disorder. [2022]

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

Right prefrontal repetitive transcranial magnetic stimulation in obsessive-compulsive disorder: a double-blind, placebo-controlled study. [2006]

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

Efficacy of Repetitive Transcranial Magnetic Stimulation on Comorbid Anxiety and Depression Symptoms in Obsessive-Compulsive Disorder: A Meta-Analysis of Randomized Sham-Controlled Trials. [2023]

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

A randomized controlled study of sequentially applied repetitive transcranial magnetic stimulation in obsessive-compulsive disorder. [2019]

7. 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]

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

Assessing the Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive- Compulsive Disorder. [2022]

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

TMS-induced plasticity improving cognitive control in OCD I: Clinical and neuroimaging outcomes from a randomised trial of rTMS for OCD. [2023]