What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include medications such as selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT). SSRIs can cause side effects like nausea, headache, sleep disturbances, and sexual dysfunction. CBT is generally well-tolerated but may cause temporary increases in anxiety. Transcranial Magnetic Stimulation (TMS), which modulates neural activity in brain circuits associated with compulsive behavior, has been associated with mild side effects such as scalp discomfort, headaches, and, rarely, seizures. These side effects are generally mild and transient.

What prior FDA approvals exist?

The FDA has approved several treatments for Obsessive-Compulsive Disorder (OCD), including medications like selective serotonin reuptake inhibitors (SSRIs) and the tricyclic antidepressant clomipramine. While Transcranial Magnetic Stimulation (TMS) is being studied for its potential to modulate neural activity in brain circuits associated with compulsive behavior, it is not yet FDA-approved specifically for OCD. However, TMS has shown promise in clinical trials and is approved for other conditions such as depression, indicating its potential utility in OCD treatment pending further research.

What other types of research exist?

Promising, novel alternatives to TMS for treating OCD include noninvasive vagus nerve stimulation (nVNS) and remote electrical neuromodulation devices. These treatments have shown efficacy in clinical trials and are emerging as potential options for patients with OCD.

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Procedure

TMS + Exposure Therapy for Pediatric OCD (NExT Trial)

N/A

Recruiting

Led By Christine Conelea, PhD

Research Sponsored by Bradley Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two weeks

Awards & highlights

Summary

This trial tests whether combining TMS with ERP therapy can help young people with OCD better manage their compulsions. TMS uses magnetic fields to stimulate brain areas linked to compulsive behavior. The study will compare different types of TMS to see which works best. Repetitive transcranial magnetic stimulation (rTMS) has been widely used as a therapy for severe obsessive-compulsive disorder (OCD).

Who is the study for?

This trial is for young people aged 12-21 with moderate to severe OCD, as shown by specific test scores. They must speak English and have motor compulsions. It's not for left-handed individuals, those on certain medications or with conditions that increase TMS risks (like epilepsy), pregnant girls not using contraception, anyone unable to undergo MRI, or if they've had psychosis, recent substance abuse, other OCD therapies or TMS treatments recently.

What is being tested?

The study tests how different types of transcranial magnetic stimulation (TMS) can help improve Exposure with Response Prevention therapy in treating OCD. Participants will receive either active TMS targeting specific brain areas or sham TMS alongside their therapy over two weeks and will be assessed through interviews, questionnaires, tasks and MRIs.

What are the potential side effects?

TMS may cause discomfort at the stimulation site, headache, lightheadedness or seizures in rare cases. The risk of side effects varies based on individual health profiles and the specifics of the TMS procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at two weeks (post-treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at two weeks (post-treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at two weeks (post-treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional Magnetic Resonance Imaging (fMRI): connectivity of the dlPFC-DMS circuit

Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit

Observed Compulsive Behavior

Secondary study objectives

Child/Adult Yale-Brown Obsessive Compulsive Inventory

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ERP+iTBSExperimental Treatment2 Interventions

Participants will receive two weeks (10 sessions) of intermittent theta burst stimulation (iTBS; a form of TMS) targeting the dorsolateral prefrontal cortex (dlPFC), followed immediately by Exposure Plus Response Prevention (ERP).

Group II: ERP+cTBSExperimental Treatment2 Interventions

Participants will receive two weeks (10 sessions) of continuous theta burst stimulation (cTBS; a form of TMS) targeting the presupplementary motor area (pSMA), followed immediately by Exposure Plus Response Prevention (ERP).

Group III: ERP+ShamActive Control2 Interventions

Participants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) include neuromodulation techniques like Transcranial Magnetic Stimulation (TMS) and pharmacological treatments such as selective serotonin reuptake inhibitors (SSRIs). TMS works by modulating neural activity in brain circuits associated with compulsive behavior, directly targeting the dysfunctional areas involved in OCD. SSRIs increase serotonin levels in the brain, which helps to reduce OCD symptoms by improving mood and reducing anxiety. These treatments are crucial for OCD patients as they aim to correct the underlying neural imbalances, offering potential relief from compulsions and improving quality of life.

[Repetitive transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder].

Find a Location

Who is running the clinical trial?

Bradley HospitalLead Sponsor

17 Previous Clinical Trials

1,501 Total Patients Enrolled

3 Trials studying Obsessive-Compulsive Disorder

563 Patients Enrolled for Obsessive-Compulsive Disorder

University of MinnesotaOTHER

1,413 Previous Clinical Trials

1,561,343 Total Patients Enrolled

3 Trials studying Obsessive-Compulsive Disorder

44 Patients Enrolled for Obsessive-Compulsive Disorder

Butler HospitalOTHER

130 Previous Clinical Trials

16,433 Total Patients Enrolled

12 Trials studying Obsessive-Compulsive Disorder

387 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

TMS + Exposure Therapy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05931913 — N/A

Obsessive-Compulsive Disorder Research Study Groups: ERP+iTBS, ERP+cTBS, ERP+Sham

Obsessive-Compulsive Disorder Clinical Trial 2023: TMS + Exposure Therapy Highlights & Side Effects. Trial Name: NCT05931913 — N/A

TMS + Exposure Therapy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05931913 — N/A

~36 spots leftby Jun 2025

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