60 Participants NeededMy employer runs this trial

Transcranial Magnetic Stimulation + Exposure Therapy for Pediatric OCD

(NExT Trial)

Recruiting at 1 trial location
KB
Overseen ByKristen Benito, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to explore whether adding transcranial magnetic stimulation (TMS) to Exposure with Response Prevention (ERP) therapy can improve outcomes for young people with Obsessive-Compulsive Disorder (OCD). Participants will divide into two groups: one will receive real TMS, and the other will receive a sham version, both alongside ERP therapy. The researchers aim to determine if TMS can reduce OCD symptoms by altering brain activity. This trial suits individuals aged 12 to 21 who experience moderate OCD symptoms and have motor compulsions affecting daily life. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for OCD.

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

Research has shown that transcranial magnetic stimulation (TMS) is generally safe for treating obsessive-compulsive disorder (OCD) in both adults and children. Studies have found that TMS can help reduce OCD symptoms and is usually well-tolerated, with most side effects being mild. This trial uses a specific type of TMS called continuous theta burst stimulation (cTBS), which has proven effective without causing significant side effects. While the FDA has approved TMS for adults with OCD, research suggests it is also safe for children and teenagers. Therefore, participation in this trial is supported by a strong safety record from previous studies.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the potential of combining transcranial magnetic stimulation (TMS) with exposure therapy for pediatric OCD because it introduces a novel approach to treatment. Traditional OCD treatments often rely on medications like SSRIs or cognitive-behavioral therapy alone. Unlike these options, this treatment uses continuous theta burst stimulation (cTBS), a form of TMS, targeting the presupplementary motor area to potentially enhance the effects of Exposure with Response Prevention (ERP). Additionally, the innovative use of TMS could expedite treatment results, possibly reducing the time needed to see improvements in symptoms. This approach not only offers a different mechanism of action but also provides a non-invasive option that may benefit those who have not responded well to standard treatments.

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

This trial will compare the effects of combining transcranial magnetic stimulation (TMS) with exposure therapy for pediatric OCD. Research has shown that TMS can help treat obsessive-compulsive disorder (OCD), especially when combined with exposure therapy. Participants in one arm of this trial will receive continuous theta burst stimulation (cTBS), a specific type of TMS, followed by Exposure Plus Response Prevention (ERP). Studies have found that TMS can reduce OCD symptoms and improve brain function linked to compulsive behavior. In one study, TMS significantly reduced OCD symptoms compared to a placebo. Another study discovered that cTBS might be a helpful addition to regular OCD treatments. Overall, TMS is considered a safe and effective method that could enhance the benefits of exposure therapy for young people with OCD.12346

Who Is on the Research Team?

CC

Christine Conelea

Principal Investigator

University of Minnesota

KB

Kristen Benito, PhD

Principal Investigator

Emma Pendleton Bradley Hospital

Are You a Good Fit for This Trial?

This trial is for children, teens, and young adults diagnosed with Obsessive-Compulsive Disorder (OCD) who are able to participate in therapy sessions and brain scans. People with certain medical or psychiatric conditions may not be eligible.

Inclusion Criteria

I have repetitive movements listed on the CY-BOCS compulsion checklist.
English fluency to ensure comprehension of informed consent and study measures and instructions
I am between 12 and 21 years old.
See 1 more

Exclusion Criteria

Decline to provide informed consent
Personal or first-born relative family history of any medical or psychiatric disorder that may impact TMS risk profile, reduce ability to fulfill study requirements, or adversely impact data integrity or study validity, including epilepsy, bipolar disorder, intracranial pathology, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, or moderate-severe heart disease
I have had TMS treatment within the last 3 months.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily TMS followed by ERP for two weeks (10 sessions)

2 weeks
10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Exposure with Response Prevention
  • Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area

Trial Overview

The study compares two groups: one receives real transcranial magnetic stimulation (TMS) plus exposure therapy (ERP), while the other gets fake TMS plus ERP. Both groups have daily sessions for two weeks to see if TMS helps improve OCD symptoms.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ERP+cTBSExperimental Treatment2 Interventions
Group II: ERP+ShamActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bradley Hospital

Lead Sponsor

Trials
22
Recruited
1,900+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

Butler Hospital

Collaborator

Trials
133
Recruited
16,700+

Citations

Efficacy and safety of accelerated transcranial magnetic ...

Accelerated TMS significantly reduced OCD and depressive symptoms, and increased response rate compared to sham aTMS. with mild adverse effects.

Transcranial Magnetic Stimulation in Obsessive-Compulsive ...

TMS demonstrates promise as an effective and safe intervention for both adults with OCD and adolescents with depression, though the evidence ...

NCT05931913 | TMS + Exposure Therapy for Pediatric OCD

Repetitive transcranial magnetic stimulation (rTMS) can be leveraged to stimulate healthier functioning of brain circuits underlying therapy critical behaviors.

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 ...

Transcranial Magnetic Stimulation (TMS) for OCD

TMS technology is used to treat a wide range of mental health disorders and health problems, including major depressive disorder, migraine headaches, and ...

Medline ® Abstract for Reference 72 of 'Obsessive ...

CONCLUSIONS Available data suggest that risk from TMS/theta-burst stimulation in children is similar to adults. We recommend that TMS users in this ...