rTMS for Obsessive-Compulsive Disorder

(BOSS-OCD Trial)

Overseen By Nina E. Bahl, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must be taking: SSRIs

Must not be taking: Benzodiazepines, Anticonvulsants

Disqualifiers: Substance use disorder, Seizures, others

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

Compensation: Varies

Number of Visits: 30

Duration: 6 weeks

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have started or increased any psychotropic medications in the 4 weeks before screening. If you take more than 2mg of lorazepam or any anticonvulsant medication, you may not be eligible.

What data supports the effectiveness of the treatment Brain-Oscillation Synchronized Stimulation of the DMPFC for Obsessive-Compulsive Disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) targeting the dorsomedial prefrontal cortex (dmPFC) can reduce symptoms in some patients with OCD, with about half of the patients experiencing significant improvement. This treatment works by reducing abnormal brain connectivity, which is linked to OCD symptoms. ^{1 2 3 4 5}

Is rTMS safe for treating obsessive-compulsive disorder?

Repetitive Transcranial Magnetic Stimulation (rTMS) has been studied for safety in treating obsessive-compulsive disorder and is generally well-tolerated in humans, with studies showing it can be safely used even in patients with severe symptoms. ^{1 2 4 6 7}

How does the treatment Brain-Oscillation Synchronized Stimulation of the DMPFC differ from other treatments for OCD?

This treatment is unique because it uses repetitive transcranial magnetic stimulation (rTMS) to target the dorsomedial prefrontal cortex (dmPFC), aiming to reduce abnormal brain connectivity associated with OCD. Unlike traditional therapies, it focuses on neuromodulation to alter brain circuits directly, which may be beneficial for patients who do not respond to conventional treatments. ^{1 2 3 4 6}

What is the purpose of this trial?

This trial aims to obtain initial evidence about the clinical efficacy and modulation of neurophysiological markers in obsessive compulsive disorder (OCD) using personalized (i.e., electroencephalography (EEG)-triggered) repetitive transcranial magnetic stimulation (rTMS) as compared to non-personalized (i.e., non-EEG triggered), standard rTMS applied to the dorsomedial prefrontal cortex.

Research Team

Brigitte Zrenner, MD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

This trial is for adults aged 18-65 with primary OCD that hasn't improved after therapy or an SSRI. Participants must have a Y-BOCS score >20, speak English fluently, and not be on new psychotropics within the last month. Excluded are those with TMS contraindications like metal implants, pacemakers, seizure history, substance use disorders (except nicotine/caffeine), or serious medical conditions.

Inclusion Criteria

Do not meet criteria for substance use disorder as determined by the MINI (with the exception of nicotine and caffeine)

Have a Y-BOCS score >20

Are fluent in the English language (spoken, written, reading)

Exclusion Criteria

Have any contraindications to TMS as determined by the Transcranial Magnetic Stimulation Adult Safety Screen (TASS) questionnaire

Are pregnant or breast feeding

Have any metal implants or dentures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EEG-triggered or non-EEG triggered rTMS treatment for OCD

6 weeks

30 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Brain-Oscillation Synchronized Stimulation of the DMPFC

Trial Overview The study tests whether personalized EEG-triggered rTMS is more effective than standard non-EEG triggered rTMS when applied to the dorsomedial prefrontal cortex in treating refractory OCD. It also looks at changes in neurophysiological markers associated with these treatments.

Participant Groups

Group I: Personalized, EEG-triggered rTMS Experimental Treatment 1 Intervention

Group II: Non-personalized, non-EEG triggered rTMS Active Control 1 Intervention

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Findings from Research

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 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]

In a randomized sham-controlled study involving 21 medication-resistant OCD patients, 67% of those receiving active rTMS to the supplementary motor area showed a significant response, compared to only 22% in the sham group, indicating the efficacy of rTMS in reducing OCD symptoms.

Patients who underwent 8 weeks of active rTMS experienced a substantial improvement in their OCD symptoms, with scores on the Yale-Brown Obsessive Compulsive Scale decreasing from an average of 28.2 to 14.5, suggesting that rTMS may normalize cortical hyper-excitability associated with OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. Mantovani, A., Simpson, HB., Fallon, BA., et al.[2021]

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]

References

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

Reductions in Cortico-Striatal Hyperconnectivity Accompany Successful Treatment of Obsessive-Compulsive Disorder with Dorsomedial Prefrontal rTMS. [2018]

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. 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]

4. Ireland pubmed.ncbi.nlm.nih.gov

Neural correlates associated with symptom provocation in pediatric obsessive compulsive disorder after a single session of sham-controlled repetitive transcranial magnetic stimulation. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. [2021]

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. Ireland pubmed.ncbi.nlm.nih.gov

Use of right orbitofrontal repetitive transcranial magnetic stimulation (rTMS) augmentation for treatment-refractory obsessive-compulsive disorder with comorbid major depressive disorder. [2023]