rTMS + Cognitive Behavioural Therapy for Obsessive-Compulsive Disorder

Overseen By Kailee Kassardjian

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: OCD medications

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

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

Compensation: Varies

Number of Visits: 10

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding a brain-stimulating procedure called rTMS, which uses energy pulses to enhance brain function, can increase the effectiveness of cognitive behavioral therapy (CBT) for people with obsessive-compulsive disorder (OCD). Participants will receive either CBT alone or a combination of rTMS and CBT to assess whether rTMS can improve attention, memory, and learning, thereby enhancing CBT's effectiveness. This could lead to better treatment options for OCD. Individuals with significant OCD symptoms who are stable on their medications might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to experience this innovative approach.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for people with severe OCD. In these studies, most participants tolerated rTMS, which uses magnetic pulses to stimulate the brain, well. Research also indicates that rTMS can significantly reduce OCD symptoms without major side effects. These studies reported no serious negative effects. Many participants experienced only mild side effects, such as headaches or dizziness, which typically resolved shortly after treatment.

Other research has found rTMS to be safe for treating depression, further supporting its safety. rTMS is already used in some clinics for other conditions, demonstrating its established safety for various uses. However, since individual responses can vary, discussing any concerns with the study team is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining rTMS with Cognitive Behavioral Therapy (CBT) for treating Obsessive-Compulsive Disorder (OCD) because it offers a fresh approach to tackling the condition. Unlike traditional treatments like SSRIs or standalone CBT, repetitive Transcranial Magnetic Stimulation (rTMS) uses magnetic fields to stimulate nerve cells in the brain, potentially enhancing the effects of CBT. This combined approach could lead to more rapid and effective symptom relief, giving new hope to individuals who haven't responded well to existing therapies.

What evidence suggests that rTMS is effective for improving cognitive functioning in OCD?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can help lessen OCD symptoms. Studies indicate that rTMS offers a moderate benefit by reducing symptom severity. One study found rTMS effective using standard measures like the Yale Brown Obsessive Compulsive Scale. These findings suggest that rTMS might enhance thinking skills, such as attention and memory, potentially improving the effectiveness of cognitive behavioral therapy (CBT). In this trial, one group will receive rTMS followed by CBT, which might lead to improved outcomes for people with OCD. Another group will receive CBT only. ^{3 6 7 8 9}

Who Is on the Research Team?

Peter Giacobbe, M.D.

Principal Investigator

Sunnybrook Health Sciences Centre

Neil A. Rector, Ph.D.

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• rTMS

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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 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) 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 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]

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]

Citations

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A Meta-analysis of Transcranial Magnetic Stimulation in ... Results: Across randomized controlled trials, rTMS exhibited a moderate therapeutic effect (g = 0.65) on OCD symptom severity and a 3-fold ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165032722000544

Repetitive transcranial magnetic stimulation for obsessive- ... The pairwise meta-analysis showed that rTMS for OCD is efficacious across all protocols (Hedges' g=-0.502 [95%CI= -0.708, -0.296]). The first ...

3. psychiatrist.com psychiatrist.com/pcc/effectiveness-repetitive-transcranial-magnetic-stimulation-depression-schizophrenia-obsessive-compulsive-disorder-umbrella-meta-analysis/

Effectiveness of Repetitive Transcranial Magnetic ... Results: 28 meta-analyses were included; 13 were on treatment-resistant depression, 9 on schizophrenia, and 6 on OCD. In treatment-resistant ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00106249

Transcranial Magnetic Stimulation (TMS) and Obsessive ... Compared to sham (placebo), active rTMS will improve symptoms of OCD as assessed with the Yale Brown Obsessive Compulsive Scale (Y-BOCS) and Clinical Global ...

5. nature.com nature.com/articles/s41398-021-01453-0

Efficacy and tolerability of repetitive transcranial magnetic ... Jahangard, L. et al. Repetitive Transcranial magnetic stimulation improved symptoms of obsessive-compulsive disorder, but also cognitive ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21623668/

Safety and efficacy of repetitive transcranial magnetic ... In this paper, we review the safety and efficacy of rTMS in the treatment of mostly severe resistant OCD.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1876201825000632

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.

8. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2019.18101180

Efficacy and Safety of Deep Transcranial Magnetic ... The results indicate that dTMS stimulation over the mPFC and ACC is a safe and effective intervention for improving OCD symptoms in patients who ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00106249

Transcranial Magnetic Stimulation (TMS) and Obsessive ... This study will evaluate the clinical efficacy of functional Magnetic Resonance Imaging (fMRI) guided 1 Hz repetitive Transcranial Magnetic Stimulation ...