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Procedure

TMS + Exposure Therapy for Pediatric OCD (NExT Trial)

N/A
Recruiting
Led By Kristen Benito, 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 studies if two forms of TMS combined with ERP can help Obsessive-Compulsive Disorder (OCD) in youth & young adults. Participants will get brain scans, daily TMS & ERP for 2 weeks.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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).

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
16 Previous Clinical Trials
1,434 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
563 Patients Enrolled for Obsessive-Compulsive Disorder
University of MinnesotaOTHER
1,395 Previous Clinical Trials
1,553,265 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
~40 spots leftby Jun 2025