TMS + Exposure Therapy for Pediatric OCD: Second Phase
NExT
Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD
Sponsor study identifier
Secondary identifiers
NIH
interventional
60
1 country
2
Study Start
October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to test transcranial magnetic stimulation (TMS) for improving the outcomes of Exposure with Response Prevention (ERP) in youth and young adults with Obsessive-Compulsive Disorder (OCD). Researchers will compare two groups: ERP with active ("real") TMS vs. ERP with sham ("fake") TMS. The first phase of this study found that active TMS+ERP normalized functioning in brain circuits that contribute to compulsive behavior. This second phase will test whether TMS-induced brain changes lead to improvements in OCD symptom severity. Participants will:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2026
Actual (reported)October 6, 2026
Actual (reported)October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit
correlation coefficient representing resting state connectivity between presupplementary motor area (pSMA) and dorsolateral striatum (DLS)
two weeks (post-treatment)
Observed Compulsive Behavior
Duration of time during which compulsions are observed during ERP sessions
two weeks
Child/Adult Yale-Brown Obsessive Compulsive Inventory
Independent-Evaluator (IE) rated measure of OCD symptom severity. Rated on 0 (no symptoms) to 40 (most extreme symptoms) scale
six weeks (1-month follow-up)
Clinical Global Impressions Scale-Improvement
six weeks (1-month follow-up)
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).
Participants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP).
TMS will be delivered over the pre supplementary motor area (preSMA) using a continuous bursting pattern
Sham stimulation will use the Magstim sham air-cooled coil, which produces auditory signals and appears identical to an active coil but contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (\<3%) magnetic field is delivered to the cortex
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Emma Pendleton Bradley Hospital
Providence, Rhode Island, 02915, United States
Kristen Benito, PhD
Emma Pendleton Bradley Hospital
Christine Conelea
University of Minnesota
First Submitted
October 1, 2026
First Posted
October 6, 2026
Study Start
October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) for Treatment of Post-Traumatic Stress Disorder (PTSD)
ERP will be delivered daily, immediately following TMS
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Primary Completion
August 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 19, 2026
Record last verified: 2026-10
We will share all de-identified data from study measures through the National Institute of Mental Health (NIMH) Data Archive (NDA) using the data dictionaries available in NDA. As per NIMH Data Archive, data will be deidentified and assigned a Global Unique Identifier (GUID).
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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