Clinical trial NCT05931913: TMS + Exposure Therapy for Pediatric OCD
Official title: Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Butler Hospital
First posted: 2023-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quadruple-masked Randomized Controlled Trial (RCT) with parallel assignment
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare different forms of 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 three groups: ERP with one of two different active ("real") forms of TMS vs. ERP with sham ("fake") TMS. The main questions this study aims to answer are: 1) whether TMS normalizes functioning in brain circuits that contribute to compulsive behavior, and 2) whether TMS reduces compulsions during ERP. Participants will:

* Complete clinical interviews, questionnaires, and computerized tasks
* Complete two MRIs (brain scans)
* Receive daily TMS followed by ERP for two weeks (10 sessions)

Detailed description: 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)

Primary outcomes:
measure: Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit
timeFrame: change from baseline at two weeks (post-treatment)
measure: Functional Magnetic Resonance Imaging (fMRI): connectivity of the dlPFC-DMS circuit
timeFrame: change from baseline at two weeks
measure: Observed Compulsive Behavior
timeFrame: two weeks
Secondary outcomes:
measure: Child/Adult Yale-Brown Obsessive Compulsive Inventory
timeFrame: change from baseline at two weeks (post-treatment)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Riverside
country: United States
facility: Emma Pendleton Bradley Hospital
state: Rhode Island
Study officials:
affiliation: Emma Pendleton Bradley Hospital
name: Kristen Benito, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Christine Conelea, PhD
role: PRINCIPAL_INVESTIGATOR
References: