Combining TMS with Exposure Therapy for Kids with OCD
Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD
NA · Bradley Hospital · NCT05931913
This study is testing if adding a brain stimulation treatment to exposure therapy can help kids and young adults with OCD feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | Bradley Hospital (other) |
| Locations | 2 sites (Minneapolis, Minnesota and 1 other locations) |
| Trial ID | NCT05931913 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of different forms of transcranial magnetic stimulation (TMS) in enhancing exposure therapy for youth and young adults suffering from Obsessive-Compulsive Disorder (OCD). Participants aged 12 to 21 will undergo a series of assessments, including clinical interviews and MRIs, followed by daily TMS sessions combined with exposure therapy over two weeks. The study will compare the outcomes of two active TMS methods against a sham treatment to determine their impact on brain function and compulsive behaviors during therapy. The goal is to see if TMS can improve the efficacy of exposure therapy by normalizing brain circuit functioning related to compulsivity.
Who should consider this trial
Good fit: Ideal candidates are youth aged 12 to 21 years who have moderate to severe OCD symptoms.
Not a fit: Patients with a history of certain psychiatric disorders or medical conditions that may complicate TMS treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for young patients with OCD.
How similar studies have performed: While the combination of TMS and exposure therapy is a novel approach, previous studies have shown promise in using TMS for various psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Minneapolis, Minnesota and 1 other locations
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
- Emma Pendleton Bradley Hospital — Riverside, Rhode Island, United States (RECRUITING)
Study contacts
- Principal investigator: Kristen Benito, PhD — Emma Pendleton Bradley Hospital
- Study coordinator: Kristen Benito, PhD
- Email: kbenito@lifespan.org
- Phone: 410-432-1054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obsessive-Compulsive Disorder