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TMS + Exposure Therapy for Pediatric OCD: Second Phase (NExT)

2026年10月15日 更新者:Kristen Benito、Bradley Hospital

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

The goal of this clinical trial is to test 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 two groups: ERP with active ("real") TMS vs. ERP with sham ("fake") TMS. The first phase of this study found that active TMS+ERP normalized functioning in brain circuits that contribute to compulsive behavior. This second phase will test whether TMS-induced brain changes lead to improvements in OCD symptom severity. 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)

研究概览

详细说明

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 hypothesized circuits involved in compulsivity and whether this leads to clinical improvement. Youth ages 12-21 years with OCD will complete a full course of ERP plus randomly assigned TMS regimens of sham or continuous theta burst stimulation (cTBS) to the presupplementary motor area (pSMA; n=30 per group).

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Minnesota
      • Minneapolis、Minnesota、美国、55414
        • 招聘中
        • University of Minnesota
        • 接触:
    • Rhode Island
      • Providence、Rhode Island、美国、02915
        • 招聘中
        • Emma Pendleton Bradley Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 21年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.
  • 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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的: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).

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

其他名称:
  • 经颅磁刺激
  • 神经调节
  • cTBS

ERP will be delivered daily, immediately following TMS

其他名称:
  • 认知行为疗法
  • CBT
  • 暴露疗法
  • 企业资源计划
有源比较器:ERP+Sham

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

ERP will be delivered daily, immediately following TMS

其他名称:
  • 认知行为疗法
  • CBT
  • 暴露疗法
  • 企业资源计划

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

其他名称:
  • 经颅磁刺激
  • 神经调节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit
大体时间:two weeks (post-treatment)

correlation coefficient representing resting state connectivity between presupplementary motor area (pSMA) and dorsolateral striatum (DLS)

two weeks (post-treatment)
Observed Compulsive Behavior
大体时间:two weeks

Duration of time during which compulsions are observed during ERP sessions

two weeks
Child/Adult Yale-Brown Obsessive Compulsive Inventory
大体时间:six weeks (1-month follow-up)

Independent-Evaluator (IE) rated measure of OCD symptom severity. Rated on 0 (no symptoms) to 40 (most extreme symptoms) scale

six weeks (1-month follow-up)

次要结果测量

结果测量
措施说明
大体时间
Clinical Global Impressions Scale-Improvement
大体时间:six weeks (1-month follow-up)

Independent-Evaluator (IE) rated measure of clinical improvement. Rated on 1 (very much improved) to 7 (very much worse) scale

six weeks (1-month follow-up)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kristen Benito, PhD、Emma Pendleton Bradley Hospital
  • 首席研究员:Christine Conelea、University of Minnesota

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月31日

初级完成 (估计的)

2029年8月31日

研究完成 (估计的)

2029年10月31日

研究注册日期

首次提交

2026年10月1日

首先提交符合 QC 标准的

2026年10月1日

首次发布 (实际的)

2026年10月6日

研究记录更新

最后更新发布 (实际的)

2026年10月19日

上次提交的符合 QC 标准的更新

2026年10月15日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

We will share all de-identified 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).

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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