NExT: TMS + Exposure Therapy for Pediatric OCD
Study Details
Study Description
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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, iTBS to dlPFC, or cTBS to 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ERP+iTBS 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). |
Device: Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex
TMS will be delivered over the dorsolateral prefrontal cortex (dlPFC) using an intermittent bursting pattern
Other Names:
Behavioral: Exposure with Response Prevention
ERP will be delivered daily, immediately following TMS
Other Names:
|
| Experimental: ERP+cTBS 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). |
Behavioral: Exposure with Response Prevention
ERP will be delivered daily, immediately following TMS
Other Names:
Device: Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area
TMS will be delivered over the pre supplementary motor area (preSMA) using a continuous bursting pattern
Other Names:
|
| Active Comparator: ERP+Sham Participants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP). |
Behavioral: Exposure with Response Prevention
ERP will be delivered daily, immediately following TMS
Other Names:
Device: Transcranial Magnetic Stimulation: Sham
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit [change from baseline at two weeks (post-treatment)]
z-score representing change in resting state connectivity between presupplementary motor area (pSMA) and dorsolateral striatum (DLS)
- Functional Magnetic Resonance Imaging (fMRI): connectivity of the dlPFC-DMS circuit [change from baseline at two weeks]
z-score representing change in resting connectivity between dorsolateral prefrontal cortex and dorsomedial striatum (DMS)
- Observed Compulsive Behavior [two weeks]
Mean proportion of time during which compulsions are observed during ERP sessions
Secondary Outcome Measures
- Child/Adult Yale-Brown Obsessive Compulsive Inventory [change from baseline at two weeks (post-treatment)]
Independent-Evaluator (IE) rated measure of OCD symptom severity. Rated on 0 (no symptoms) to 40 (most extreme symptoms) scale
Eligibility Criteria
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.
-
Medical conditions contraindicated or associated with altered TMS risk profile, including: History of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, current pregnancy or girls of childbearing age not using effective contraception, or any other serious medical condition.
-
Inability to undergo MRI.
-
Left handedness.
-
Active suicidality.
-
Previous diagnosis of psychosis or cognitive disability.
-
Substance abuse or dependence within the past year.
-
Concurrent psychotherapy focused on 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 increased seizure risk 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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55414 |
| 2 | Emma Pendleton Bradley Hospital | Riverside | Rhode Island | United States | 02915 |
Sponsors and Collaborators
- Bradley Hospital
- University of Minnesota
- Butler Hospital
Investigators
- Principal Investigator: Kristen Benito, PhD, Emma Pendleton Bradley Hospital
- Principal Investigator: Christine Conelea, PhD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00072077