TMS + Psychotherapy for OCD

Overseen By Emma Garland, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Adam Frank

Must be taking: Serotonin Reuptake Inhibitors

Disqualifiers: Substance use, Suicidality, Psychosis, Seizures, others

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how individuals with Obsessive-Compulsive Disorder (OCD) respond to a brain stimulation method called repetitive Transcranial Magnetic Stimulation (rTMS) when paired with therapy. Participants will receive either Exposure and Response Prevention (ERP) therapy or supportive therapy while undergoing rTMS. Researchers will use wearable devices and smartphones to collect data on participants' responses to the treatment. This trial suits those living in Southern California who have been diagnosed with OCD, completed ERP therapy, and are willing to attend sessions five times a week. As an unphased trial, it offers a unique opportunity to contribute to cutting-edge research and potentially benefit from innovative treatment options.

Do I have to stop taking my current medications for the trial?

No, you don't have to stop taking your current medications. You need to keep your psychotropic medication levels the same throughout the 16 weeks of the study.

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 and well-tolerated. Research indicates that rTMS can influence brain activity without causing major side effects. The FDA has approved rTMS for treating conditions such as OCD, migraines, and smoking cessation, indicating it has passed safety checks for these uses. Some individuals might experience minor side effects like headaches or scalp discomfort, but these are usually mild and temporary. Overall, rTMS appears promising as a safe option for those considering it as part of their OCD treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining transcranial magnetic stimulation (TMS) with psychotherapy for treating OCD because it offers a unique approach compared to traditional methods like medication and cognitive-behavioral therapy. TMS uses magnetic fields to stimulate specific brain areas involved in OCD, potentially providing relief without the side effects of medication. This method is non-invasive, meaning it doesn't require surgery or medication, and can be used alongside existing therapies, possibly enhancing their effectiveness. By integrating TMS with Exposure and Response Prevention (ERP) therapy, researchers hope to boost treatment outcomes, offering a promising alternative for those who haven't found success with current options.

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

Research has shown that repetitive Transcranial Magnetic Stimulation (rTMS) can help reduce symptoms in people with OCD. In this trial, participants will receive either rTMS combined with Exposure and Response Prevention (ERP) Therapy or rTMS combined with Supportive Therapy (ST). One study found that rTMS led to a moderate decrease in OCD symptoms, indicating a noticeable but not dramatic change. Another study noted that rTMS could also help with depression symptoms, which often occur alongside OCD. However, it did not seem to help with anxiety. Overall, rTMS is considered a promising option for treating OCD, especially for those who haven't found relief with other treatments. ^{1 5 6 7 8}

Who Is on the Research Team?

Adam C. Frank, MD, PhD

Principal Investigator

Keck School of Medicine of USC

Are You a Good Fit for This Trial?

This trial is for individuals with Obsessive-Compulsive Disorder (OCD) who are eligible to undergo brain stimulation and psychotherapy. Participants must be able to wear biobehavioral tracking devices and consent to repeated brain imaging tests. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I have taken or am currently taking SRI medication for OCD.

I have been diagnosed with OCD according to DSM-5.

I live in Southern California and can attend in-person sessions 5 times a week for 6 weeks.

Exclusion Criteria

Active suicidality

I have a history of seizures.

Primary psychiatric diagnosis other than OCD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants complete baseline assessments, including questionnaires, brain scan, and receive a Fitbit device

1 week

1 visit (in-person)

Treatment

Participants receive rTMS and either ERP or supportive therapy. Weekly OCD symptom assessments are conducted.

6 weeks

5 visits per week (in-person), 2 therapy sessions per week (virtual)

Post-Treatment Assessment

Participants repeat the brain scan and complete final symptom and functioning assessments. Fitbit data collection and daily surveys cease.

1 week

1 visit (in-person)

Follow-up

Participants complete a follow-up assessment to evaluate longer-term outcomes.

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exposure and Response Prevention (ERP) Therapy
• Supportive Therapy (ST)
• TMS

Trial Overview The study is testing the effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) combined with two types of psychotherapy: Exposure and Response Prevention (ERP) Therapy or Supportive Therapy (ST). It also aims to identify treatment response predictors using wearable device data and MRI scans.

How Is the Trial Designed?

Group I: rTMS+ERP Active Control 2 Interventions

Group II: rTMS+ST Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Adam Frank

Lead Sponsor

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37343662/

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/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.

3. 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 ...

4. iocdf.org iocdf.org/about-ocd/treatment/tms/

Transcranial Magnetic Stimulation (TMS) for OCD Real-world efficacy of deep TMS for obsessive-compulsive disorder: post-marketing data collected from twenty-two clinical sites. Journal of Psychiatric ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11853550/

MAGNITUDE: Transcranial Magnetic Stimulation for Treatment ... Repetitive transcranial stimulation (rTMS) is a non-invasive, safe, and well-tolerated intervention that modulates prefrontal cortical circuits ...

7. mayoclinic.org mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00106249

Transcranial Magnetic Stimulation (TMS) and Obsessive ... Pilot work indicates that stimulation of SMA with low frequency rTMS was beneficial in OCD patients. Low frequency rTMS has the added benefit of a better safety ...