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Obsessive-Compulsive DisorderNExTNCT05931913

TMS + Exposure Therapy for Pediatric OCD

A study testing Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex, Exposure with Response Prevention and Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area in people with Obsessive-Compulsive Disorder, run by Bradley Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 12 to 21 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex, Exposure with Response Prevention and Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
2 sitesUnited States
Study dates
20 Mar 2024to 31 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • Emma Pendleton Bradley Hospital

    Riverside, Rhode Island, 02915

Other trials in United States

About this study

Official title: Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD

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)
Read the 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.

Being tested
Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex, Exposure with Response Prevention, Transcranial Magnetic Stimulation: Sham, Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortexDevice

    Also called TMS, Neuromodulation, iTBS

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

  • Exposure with Response PreventionBehavioural

    Also called ERP, Exposure Therapy, Cognitive-Behavioral Therapy, CBT

    ERP will be delivered daily, immediately following TMS

  • Transcranial Magnetic Stimulation: ShamDevice

    Also called TMS, Neuromodulation

    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

  • Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor areaDevice

    Also called TMS, iTBS, Neuromodulation

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

Study groups in NCT05931913
Study groupRoleWhat they receive
ERP+iTBSExperimentalParticipants 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).
Receives: Device: Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex; Behavioral: Exposure with Response Prevention
ERP+cTBSExperimentalParticipants 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).
Receives: Behavioral: Exposure with Response Prevention; Device: Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area
ERP+ShamActive comparatorParticipants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP).
Receives: Behavioral: Exposure with Response Prevention; Device: Transcranial Magnetic Stimulation: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit

    z-score representing change in resting state connectivity between presupplementary motor area (pSMA) and dorsolateral striatum (DLS)

    Measured: change from baseline at two weeks (post-treatment)

  2. Functional Magnetic Resonance Imaging (fMRI): connectivity of the dlPFC-DMS circuit

    z-score representing change in resting connectivity between dorsolateral prefrontal cortex and dorsomedial striatum (DMS)

    Measured: change from baseline at two weeks

  3. Observed Compulsive Behavior

    Mean proportion of time during which compulsions are observed during ERP sessions

    Measured: two weeks

Secondary outcomes (1)

  1. 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

    Measured: change from baseline at two weeks (post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2023
  2. Study start20 Mar 2024
  3. Primary completion31 Jul 2026
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Quadruple-masked Randomized Controlled Trial (RCT) with parallel assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05931913
Sponsor's protocol ID
00072077
Acronym
NExT
Status last verified
Oct 2026
First submitted
15 Jun 2023
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: We will share all de-identifiable 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). We will also share deidentified study data via the National Database for Clinical Trials (NDCT) related to Mental Illness.

Publications

  • 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.

    PubMed 39696590

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex, Exposure with Response Prevention and Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area in people with Obsessive-Compulsive Disorder, run by Bradley Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit (time frame: change from baseline at two weeks (post-treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05931913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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