Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder

Overseen By Starlette Khim, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants, Antipsychotics

Disqualifiers: Schizophrenia, Bipolar, Seizure, others

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

Compensation: Varies

Number of Visits: 15

Duration: 3 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of transcranial magnetic stimulation (TMS) to determine their effectiveness for teens with Obsessive-Compulsive Disorder (OCD) who haven't improved with other treatments. Researchers aim to assess whether participants can handle daily TMS sessions for three weeks and identify any side effects. Teens with moderate to severe OCD, stable on their current medications or therapy for at least eight weeks, might be suitable candidates. Participants will visit the clinic every weekday for three weeks and undergo MRI scans and questionnaires to track changes. As an unphased trial, this study offers a unique opportunity to explore new treatment options and contribute to advancing OCD research.

Will I have to stop taking my current medications?

No, you can continue taking your current medications as long as they have been stable for 8 weeks before the study and you agree to keep them unchanged during the study.

What prior data suggests that transcranial magnetic stimulation is safe for adolescents with OCD?

Research has shown that continuous theta-burst stimulation (cTBS) applied to the right orbitofrontal cortex (ROFC) is generally well-tolerated. One study found that people with OCD experienced noticeable improvements in anxiety symptoms and overall condition, reporting that the treatment was well-tolerated. Studies involving cTBS for OCD have not mentioned severe side effects, suggesting it is relatively safe.

For dorsal medial prefrontal cortex intermittent theta-burst stimulation (dmPFC-iTBS), studies also indicate it is safe to use. A review of trials using TMS for OCD did not highlight major safety concerns. Another study treating patients with treatment-resistant OCD using dmPFC-iTBS found it to be a tolerable treatment.

In summary, both types of TMS tested in this trial appear safe and well-tolerated according to previous research. Participants have generally not reported serious side effects, making these treatments promising for further investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about transcranial magnetic stimulation (TMS) treatments for obsessive-compulsive disorder (OCD) because they offer a non-invasive approach that directly targets brain areas involved in the condition. Unlike traditional treatments like cognitive-behavioral therapy or medications such as SSRIs, continuous theta burst stimulation (cTBS) and intermittent theta burst stimulation (iTBS) focus on specific areas of the brain, potentially leading to fewer side effects and faster results. cTBS targets the right orbitofrontal cortex, while iTBS is aimed at the dorsal medial prefrontal cortex, offering precise intervention in neural circuits linked to OCD symptoms. This targeted approach could revolutionize how we treat OCD, providing hope for those who haven't responded well to conventional therapies.

What evidence suggests that transcranial magnetic stimulation is effective for treating OCD?

In this trial, participants will receive one of two treatments for OCD. Research has shown that continuous theta burst stimulation (cTBS), applied to the right orbitofrontal cortex, can significantly improve OCD symptoms. Studies have found that this treatment is generally well tolerated and can help reduce anxiety and the overall severity of symptoms.

The other treatment option in this trial is intermittent theta burst stimulation (iTBS), which targets the dorsal medial prefrontal cortex. Evidence suggests that iTBS can effectively reduce OCD symptoms, especially for those who haven't found success with other treatments. This method focuses on brain areas involved in mood regulation, potentially easing symptoms over time.

Both treatments in this trial offer promising new options for people dealing with OCD. ^{5 6 7 8 9}

Who Is on the Research Team?

James T McCracken, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adolescents with Obsessive Compulsive Disorder (OCD) who haven't seen much improvement from standard treatments. They must be able to come to the clinic every weekday for three weeks and undergo MRI scans before and after treatment.

Inclusion Criteria

Successfully complete the screening forms without any contraindications

Meets current DSM-5 criteria for Obsessive Compulsive Disorder with screening CY-BOCS II score > 16 (moderate to severe)

I can handle the procedures involved in the study.

Exclusion Criteria

Psychiatric history of schizophrenia, bipolar disorder, substance/alcohol abuse disorder, current elevated suicide risk, prior psychosurgery, prior ECT

I don't have metal implants in my head, a history of seizures, or conditions increasing seizure risk.

I do not have any unstable health conditions like severe high blood pressure or eating disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial magnetic stimulation (TMS) treatments every weekday for 3 weeks

3 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• cTBS to ROFC
• Dorsal medial Prefrontal Cortex intermittent theta burst stimulation

Trial Overview

The study tests two types of transcranial magnetic stimulation (TMS): cTBS to ROFC, and intermittent theta burst stimulation to the dorsal medial prefrontal cortex. It aims to see if teens can handle TMS daily over three weeks and what side effects may occur.

How Is the Trial Designed?

Group I: Right Orbitofrontal TBS Experimental Treatment 1 Intervention

continuous theta burst stimulation

Group II: TBS of dorsal, medial prefrontal cortex Active Control 1 Intervention

intermittent theta burst stimulation (iTBS) will be delivered to the dmPFC

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Hearst Foundations

Collaborator

Trials

1

Recruited

50+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40578057/

Accelerated deep intermittent theta-burst stimulation for ...

Conclusion: Accelerated d-iTBS targeting the mPFC appears to be effective in reducing OCD symptoms; however, its therapeutic effects may become more apparent ...

2.

mentalhealth.bmj.com

mentalhealth.bmj.com/content/27/1/e301290

Randomised controlled trial comparing different ...

Implementing a 30-min or 60-min interval between two treatment sessions of DMPFC-iTBS does not lead to a more rapid improvement in symptoms, than once-daily ...

3.

researchgate.net

researchgate.net/publication/345976015_Adjuvant_intermittent_theta_burst_stimulation_over_dorsomedial_prefrontal_cortex_in_treatment-resistant_obsessive-compulsive_disorder

(PDF) Adjuvant intermittent theta burst stimulation over ...

PDF | We report our experience of treating 12 patients with treatment-resistant OCD with intermittent TBS (iTBS) using D-B80 double cone ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1876201824000546

Comparative efficacy of repetitive transcranial magnetic ...

Repetitive transcranial magnetic stimulation (rTMS) has been found to be helpful for the treatment of obsessive-compulsive disorder (OCD).

5.

cell.com

cell.com/cell-reports-medicine/fulltext/S2666-3791(25)00475-6

A sequential dual-site repetitive transcranial magnetic ...

Here, we examine antidepressant effects of our sequential dorsolateral prefrontal cortex (dlPFC)-dorsomedial prefrontal cortex (dmPFC) accelerated rTMS protocol ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11499886/

Randomised controlled trial comparing different intersession ...

Implementing a 30-min or 60-min interval between two treatment sessions of DMPFC-iTBS does not lead to a more rapid improvement in symptoms, than once-daily ...

7.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT07065669

Treating Adolescent Obsessive Compulsive Disorder With ...

This is a pilot study to examine the tolerability, safety and early efficacy of two forms of transcranial magnetic stimulation (TMS) for treating ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S027858462400215X

Transcranial magnetic stimulation for obsessive ...

We systematically reviewed randomised controlled trials (RCTs) applying TMS in obsessive compulsive disorder (OCD) and post-traumatic stress disorder (PTSD)

9.

diva-portal.org

diva-portal.org/smash/get/diva2:1591783/FULLTEXT01.pdf

The effect of intermittent theta-burst stimulation over the ...

This thesis aims to explore the effects of dmPFC-iTBS on brain activity in depression, using data from a randomized controlled trial and two add ...