TMS + Exposure Therapy for Pediatric OCD (NExT Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Bradley Hospital
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial tests whether combining TMS with ERP therapy can help young people with OCD better manage their compulsions. TMS uses magnetic fields to stimulate brain areas linked to compulsive behavior. The study will compare different types of TMS to see which works best. Repetitive transcranial magnetic stimulation (rTMS) has been widely used as a therapy for severe obsessive-compulsive disorder (OCD).
Is TMS + Exposure Therapy a promising treatment for pediatric OCD?Yes, TMS + Exposure Therapy is a promising treatment for pediatric OCD. TMS, a non-invasive brain stimulation technique, has shown potential in reducing OCD symptoms. When combined with Exposure Therapy, it may enhance the effectiveness of treatment for young patients with OCD.1271213
What data supports the idea that TMS + Exposure Therapy for Pediatric OCD is an effective treatment?The available research shows that TMS + Exposure Therapy can be effective for treating OCD. In a study conducted in Tokyo, 53.9% of patients with OCD showed significant improvement after 30 sessions of TMS combined with exposure therapy. This means that more than half of the patients experienced a noticeable reduction in their OCD symptoms. Additionally, the study found that these improvements were consistent regardless of whether patients were also taking medication. This suggests that TMS + Exposure Therapy could be a promising option for those who do not respond well to traditional treatments.310111314
What safety data exists for TMS + Exposure Therapy in treating pediatric OCD?The provided research does not directly address the safety data for TMS combined with Exposure Therapy for pediatric OCD. However, it discusses the safety and concerns related to Exposure and Response Prevention (ERP) therapy, a component of the treatment. The studies indicate that ERP is generally safe and does not lead to higher treatment dropout rates or adverse consequences compared to non-exposure-based treatments. There is no specific mention of safety data for Transcranial Magnetic Stimulation (TMS) in these studies.45689
Do I need to stop my current medications to join the trial?You may need to stop taking certain medications if they have high seizurogenic potential or if they haven't been stable for at least 6 weeks. Please consult with the trial team for specific guidance.
Eligibility Criteria
This trial is for young people aged 12-21 with moderate to severe OCD, as shown by specific test scores. They must speak English and have motor compulsions. It's not for left-handed individuals, those on certain medications or with conditions that increase TMS risks (like epilepsy), pregnant girls not using contraception, anyone unable to undergo MRI, or if they've had psychosis, recent substance abuse, other OCD therapies or TMS treatments recently.Participant Groups
The study tests how different types of transcranial magnetic stimulation (TMS) can help improve Exposure with Response Prevention therapy in treating OCD. Participants will receive either active TMS targeting specific brain areas or sham TMS alongside their therapy over two weeks and will be assessed through interviews, questionnaires, tasks and MRIs.
3Treatment groups
Experimental Treatment
Active Control
Group I: ERP+iTBSExperimental Treatment2 Interventions
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 II: ERP+cTBSExperimental Treatment2 Interventions
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 III: ERP+ShamActive Control2 Interventions
Participants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP).
TMS + Exposure Therapy is already approved in United States for the following indications:
🇺🇸 Approved in United States as TMS for:
- Treatment-resistant depression
- Obsessive-compulsive disorder (adults)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
Emma Pendleton Bradley HospitalRiverside, RI
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Who is running the clinical trial?
Bradley HospitalLead Sponsor
University of MinnesotaCollaborator
Butler HospitalCollaborator
References
Transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder. [2020]Transcranial magnetic stimulation (TMS) was introduced as a neurophysiological technique in 1985 when Anthony Barker and his team developed a compact machine that permitted non-invasive stimulation of the cerebral cortex (Barker 1985). Since its introduction, TMS has been used to evaluate the motor system, to study the function of several cerebral regions, and for the pathophysiology of several neuropsychiatric illnesses. In addition, it has been suggested that TMS might have therapeutic potential. Some controlled studies have evaluated the effects of repetitive TMS (rTMS) in patients with obsessive-compulsive disorder (OCD). Greenberg (Greenberg 1997) observed that a single session of right prefrontal cortex stimulation produced a significant decrease in compulsive urges in OCD patients lasting over eight hours. Other studies have reported transitory improvements in mood but there are no observations for changes in anxiety or obsessions.
Metacognitive therapy versus exposure and response prevention for pediatric obsessive-compulsive disorder. A case series with randomized allocation. [2018]Exposure with ritual prevention (ERP) is the psychotherapeutic treatment of choice for pediatric obsessive-compulsive disorder (OCD). In the present study, a new treatment rationale - metacognitive therapy (MCT) for children - was developed and evaluated.
Repetitive transcranial magnetic stimulation for the treatment of obsessive compulsive disorder: a double-blind controlled investigation. [2007]To determine the efficacy and tolerability of repetitive transcranial magnetic stimulation (rTMS) as a treatment for obsessive compulsive disorder (OCD) in a double-blind placebo-controlled study.
Stepped care versus standard cognitive-behavioral therapy for obsessive-compulsive disorder: a preliminary study of efficacy and costs. [2021]Exposure and response prevention (ERP) for obsessive-compulsive disorder (OCD) is underutilized, in part because of costs and time requirements. This study extends pilot work investigating the use of a stepped care ERP administration, in which patients are first given a low-intensity, low-cost treatment and the more costly intervention is reserved for those who do not respond to the first intervention.
A Case Report of Harm-Related Obsessions in Pediatric Obsessive-Compulsive Disorder. [2018]Harm-related, or "aggressive," obsessions are a symptom subtype in obsessive-compulsive disorder (OCD). Given the violent nature of these thoughts, the stark contrast between the child's character and the content of these obsessions often results in high levels of distress for not only the patient but also the family. This case report illustrates the application of family-based exposure and response prevention (ERP) for a 15-year-old male presenting with harm-related obsessions and mild depressive symptoms secondary to the OCD. The obsessions primarily revolved around the fear of acting on unwanted impulses (e.g., stabbing a family member, pushing a friend onto oncoming traffic), and the compulsions entailed avoidance (both mental and physical), excessive reassurance seeking, and ritualistic confessions. The client underwent a 14-week course of ERP involving repeated imaginal and in vivo exposures and behavioral activation to alleviate depressive symptoms. Significant improvements in obsessive-compulsive symptom severity and depressive symptoms were observed posttreatment, elucidating the efficacy of treating harm-related obsessions with a course of ERP.
Editorial Perspective: Exposures in cognitive behavior therapy for pediatric obsessive-compulsive disorder: addressing common clinician concerns. [2019]Professional organizations and expert consensus recommend the use of exposure-based cognitive-behavioral therapy (CBT) to treat pediatric obsessive-compulsive disorder (OCD), but a sizable proportion of clinicians possess hesitancy regarding the use of exposures in treatment. Most notably, this hesitancy relates to concerns about negative patient and parent reactions to exposures. Accordingly, we examine three commonly reported clinician concerns regarding negative patient/parent reactions (e.g. treatment attrition, therapeutic relationship, and treatment satisfaction) among youths receiving exposure-based CBT compared to a nonexposure-based treatment. Based on our findings, there is no empirical support that exposure-based CBT precipitates adverse consequences in treatment (e.g. treatment attrition, poor therapeutic relationship, low treatment satisfaction) relative to nonexposure-based interventions. These results corroborate existing OCD expert recommendations for the use of exposure-based CBT and provide information to mitigate clinicians' concerns about the potentially iatrogenic impact of exposures when treating pediatric OCD. We briefly present best practice recommendations for implementing exposure-based CBT in pediatric OCD patients.
Transcranial magnetic stimulation in obsessive-compulsive disorder: A focus on network mechanisms and state dependence. [2021]Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique that has shown promise as an adjunct treatment for the symptoms of Obsessive-Compulsive Disorder (OCD). Establishing a clear clinical role for TMS in the treatment of OCD is contingent upon evidence of significant efficacy and reliability in reducing symptoms.
A meta-analysis of dropout rates from exposure with response prevention and pharmacological treatment for youth with obsessive compulsive disorder. [2022]Beliefs that exposure with response prevention (ERP) is excessively distressing and will result in client dropout from treatment are commonly-cited reasons for clinicians not providing evidence-based treatment. This meta-analysis examined treatment attrition for ERP for youth with obsessive compulsive disorder (OCD) compared with other treatment modalities.
Serious negative consequences associated with exposure and response prevention for obsessive-compulsive disorder: A survey of therapist attitudes and experiences. [2020]Many therapists are reluctant to conduct exposure and response prevention (ERP) for obsessive-compulsive disorder (OCD). Negative beliefs about the safety and tolerability of ERP are common, especially for harm-related OCD symptoms. The study examined the nature and frequency of ERP-related serious negative consequences (SNC) and therapist attitudes and experiences providing ERP for harm-related OCD.
Efficacy of Repetitive Transcranial Magnetic Stimulation on Comorbid Anxiety and Depression Symptoms in Obsessive-Compulsive Disorder: A Meta-Analysis of Randomized Sham-Controlled Trials. [2023]To systematically evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) in reducing comorbid anxiety and depressive symptoms in patients with obsessive-compulsive disorder (OCD).
A Case Series of Deep Transcranial Magnetic Stimulation Treatment for Patients with Obsessive-Compulsive Disorder in the Tokyo Metropolitan Area. [2022]Obsessive-compulsive disorder (OCD) is a chronic illness in which patients do not achieve remission sufficiently with conventional medication. Deep repetitive transcranial magnetic stimulation (dTMS) for OCD neuromodulates the bilateral anterior cingulate cortex (ACC) and dorsal medial prefrontal cortex (mPFC), which are known to be impaired in OCD. While dTMS treatment for OCD has shown effective results overseas, TMS treatment for OCD has rarely been implemented in Japan, and its effectiveness is unknown. We conducted an FDA-approved dTMS protocol to 26 patients with OCD. In addition, individual exposure stimulation that elicited each patient's obsessive thoughts was also combined during dTMS treatment. Before and after 30 sessions of TMS treatment, the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was used to assess changes in the severity of each patient's obsessive-compulsive disorder. Response to dTMS treatment in patients with OCD was determined by whether the total score on the Y-BOCS after a course of treatment was reduced by 30% or more compared with the score at baseline. The percentage of responders in this case series following the 30 sessions of dTMS treatment was 53.9%. In addition, total Y-BOCS scores and scores on each item were significantly improved. The percent changes in total Y-BOCS scores did not differ between the sexes or between on- and off-medication patients. No obvious adverse events were observed in this case series. In line with the results of TMS studies for OCD patients reported overseas, dTMS treatment for Japanese patients with OCD may have a favorable therapeutic effect.
Motor cortical inhibitory deficits in patients with obsessive-compulsive disorder-A systematic review and meta-analysis of transcranial magnetic stimulation literature. [2023]Label="Introduction" NlmCategory="UNASSIGNED">Obsessive-compulsive disorder (OCD) is a highly prevalent chronic disorder, often refractory to treatment. While remaining elusive, a full understanding of the pathophysiology of OCD is crucial to optimize treatment. Transcranial magnetic stimulation (TMS) is a non-invasive technique that, paired with other neurophysiological techniques, such as electromyography, allows for in vivo assessment of human corticospinal neurophysiology. It has been used in clinical populations, including comparisons of patients with OCD and control volunteers. Results are often contradictory, and it is unclear if such measures change after treatment. Here we summarize research comparing corticospinal excitability between patients with OCD and control volunteers, and explore the effects of treatment with repetitive TMS (rTMS) on these excitability measures.
Will Transcranial Magnetic Stimulation Improve the Treatment of Obsessive-Compulsive Disorder? A Systematic Review and Meta-Analysis of Current Targets and Clinical Evidence. [2023]Although in 2017 a repetitive transcranial magnetic stimulation (rTMS) protocol received Food and Drug Administration approval for the first time for the treatment of obsessive-compulsive disorder (OCD), which neural target and which protocol should be used for OCD are still debated. The aim of the present study was to perform a systematic review and meta-analysis of the available open and sham-controlled trials.
TMS-induced plasticity improving cognitive control in OCD I: Clinical and neuroimaging outcomes from a randomised trial of rTMS for OCD. [2023]Repetitive transcranial magnetic stimulation (rTMS) is an emerging treatment option for obsessive-compulsive disorder (OCD). The neurobiological mechanisms of rTMS in OCD have, however, been incompletely characterized. We compared clinical outcomes and changes in task-based brain activation following three different rTMS stimulation protocols, all combined with exposure and response prevention (ERP).