TMS + Exposure Therapy for Pediatric OCD

NCT ID: NCT05931913

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2026-07-31

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex

Intervention Type: DEVICE

TMS will be delivered over the dorsolateral prefrontal cortex (dlPFC) using an intermittent bursting pattern

Exposure with Response Prevention

Intervention Type: BEHAVIORAL

ERP will be delivered daily, immediately following TMS

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).

Group Type: EXPERIMENTAL

Exposure with Response Prevention

Intervention Type: BEHAVIORAL

ERP will be delivered daily, immediately following TMS

Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area

Intervention Type: DEVICE

TMS will be delivered over the pre supplementary motor area (preSMA) using a continuous bursting pattern

ERP+Sham

Participants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP).

Group Type: ACTIVE_COMPARATOR

Exposure with Response Prevention

Intervention Type: BEHAVIORAL

ERP will be delivered daily, immediately following TMS

Transcranial Magnetic Stimulation: Sham

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Exposure with Response Prevention

ERP will be delivered daily, immediately following TMS

Intervention Type: BEHAVIORAL

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

TMS; Neuromodulation; iTBS; ERP; Exposure Therapy; Cognitive-Behavioral Therapy; CBT; TMS; Neuromodulation; TMS; iTBS; Neuromodulation

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: collaborator

Bradley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristen Benito

Associate Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristen Benito, PhD

Role: PRINCIPAL_INVESTIGATOR

Emma Pendleton Bradley Hospital

Christine Conelea, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Emma Pendleton Bradley Hospital

Riverside, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristen Benito, PhD

Role: CONTACT

kbenito@lifespan.org

410-432-1054

Christine Conelea, PhD

Role: CONTACT

cconelea@umn.edu

Facility Contacts

Christine Conelea, PhD

Role: primary

cconelea@umn.edu

612-261-3127

Kristen Benito, PhD

Role: primary

kbenito@lifespan.org

(401)-432-1473

References

Conelea C, Breitenfeldt C, Wilens A, Carpenter L, Greenberg B, Herren J, Jacob S, Lewis C, McLaughlin N, Mueller BA, Nelson S, O'Connor E, Righi G, Widge AS, Fiecas M, Benito K. The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCD. Trials. 2024 Dec 18;25(1):835. doi: 10.1186/s13063-024-08629-1.

Reference Type: DERIVED

PMID: 39696590 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Other Identifiers

00072077

Identifier Type: -

Identifier Source: org_study_id