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TMS + Exposure Therapy for Pediatric OCD
NCT05931913 · Bradley Hospital
In plain English
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Official title
Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD
About this study
Pediatric OCD is a public health problem and many remain symptomatic even after receiving efficacious treatments. The success of exposure and response prevention (ERP), a first-line behavioral treatment, depends on the ability to refrain from compulsions during exposure tasks. Improving this "therapy critical behavior" is a potentially important strategy for ERP augmentation. Repetitive transcranial magnetic stimulation (rTMS) can be leveraged to stimulate healthier functioning of brain circuits underlying therapy critical behaviors. The overall objective of this project is to test whether augmenting ERP with rTMS over cortical nodes of select cortico-striatal circuits implicated in compulsivity can normalize connectivity and enhance response prevention in youth and young adults with OCD. This project will use a masked RCT design to test whether ERP+TMS engages 1) hypothesized circuits involved in compulsivity and 2) observed response prevention during ERP exposure tasks. Youth ages 12-21 years with OCD will complete a full course of ERP plus randomly assigned TMS regimens of sham, inhibitory theta burst stimulation (iTBS) to the dorsolateral prefrontal cortext (dlPFC), or continuous theta burst stimulation (cTBS) to the presupplementary motor area (pSMA; n=20 per group). Milestones for the R61 phase are determination that at least one active rTMS condition a) changes resting state functional connectivity in the hypothesized circuit within- and between-subjects and b) is safe and feasible.
Eligibility criteria
Inclusion Criteria:
* Between the ages of 12 and 21 years.
* Presence of OCD, as indicated by a score of \> 16 on the Children's Yale-Brown Obsessive Compulsive Scale, indicating moderate or greater OCD symptoms.
* Presence of motor compulsions on CY-BOCS compulsion checklist
* English fluency to ensure comprehension of informed consent and study measures and instructions.
Exclusion Criteria:
* Decline to provide informed consent.
* Has a personal history, or a family history in a first-born relative, of any medical or psychiatric disorder, disease, condition, injury, symptoms or circumstance that, in the opinion of the principal investigator, may: (1) impact the risk profile of TMS; (2) reduce the subject's ability to fulfill the study requirements as per protocol; or (3) adversely impact the integrity of the data or the validity of the study results." Some examples include: epilepsy or seizure disorder(s), bipolar disorder or any psychiatric disorder associated with a risk of mania, intracranial pathology, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, or moderate-severe heart disease
* Pregnant according to the medical history or a urine pregnancy test; and menstruating females who are heterosexually active and not using a highly effective form of contraception (tubal ligation, FDA-approved hormonal contraceptive, or an IUD)
* Inability to undergo MRI.
* Left handedness.
* Is deemed to be at imminent risk of suicide according to the Ask Suicide-Screening Questions (ASQ) (i.e. answers YES to ≥ one (1) of the four screening questions) and/or in the medical opinion of the investigator
* History of, or risk factors for, neurocardiogenic syncope (history of syncope/ presyncope related to noxious stimuli, anxiety, micturation, or posture).
* Concurrent psychotherapy of any kind for OCD.
* Concurrent TMS or receipt of any TMS experimental or clinical treatment less than 3 months prior to enrollment.
* Taking a medication deemed to pose high seizurogenic potential per physician review
* Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the study period)
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult
Timeline
Starts: 2024-03-20
Estimated completion: 2029-10-31
Last updated: 2026-08-21
Interventions
Device: Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortexBehavioral: Exposure with Response PreventionDevice: Transcranial Magnetic Stimulation: ShamDevice: Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area
Primary outcomes
- • Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit (change from baseline at two weeks (post-treatment))
- • Functional Magnetic Resonance Imaging (fMRI): connectivity of the dlPFC-DMS circuit (change from baseline at two weeks)
- • Observed Compulsive Behavior (two weeks)
Sponsor
Bradley Hospital · other
With: University of Minnesota, Butler Hospital
Contacts & investigators
ContactKristen Benito, PhD · contact · kbenito@lifespan.org · 410-432-1054
ContactChristine Conelea, PhD · contact · cconelea@umn.edu
InvestigatorKristen Benito, PhD · principal_investigator, Emma Pendleton Bradley Hospital
InvestigatorChristine Conelea, PhD · principal_investigator, University of Minnesota
All locations (2)
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Emma Pendleton Bradley HospitalRecruiting
Riverside, Rhode Island, United States