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TMS + Exposure Therapy for Pediatric OCD (NExT Trial)
N/A
Recruiting
Led By Kristen Benito, PhD
Research Sponsored by Bradley Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two weeks
Awards & highlights
NExT Trial Summary
This trial studies if two forms of TMS combined with ERP can help Obsessive-Compulsive Disorder (OCD) in youth & young adults. Participants will get brain scans, daily TMS & ERP for 2 weeks.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
TMS may cause discomfort at the stimulation site, headache, lightheadedness or seizures in rare cases. The risk of side effects varies based on individual health profiles and the specifics of the TMS procedure.
NExT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at two weeks (post-treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at two weeks (post-treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Magnetic Resonance Imaging (fMRI): connectivity of the dlPFC-DMS circuit
Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit
Observed Compulsive Behavior
Secondary outcome measures
Child/Adult Yale-Brown Obsessive Compulsive Inventory
NExT Trial Design
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).
Find a Location
Who is running the clinical trial?
Bradley HospitalLead Sponsor
16 Previous Clinical Trials
1,434 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
563 Patients Enrolled for Obsessive-Compulsive Disorder
University of MinnesotaOTHER
1,381 Previous Clinical Trials
1,588,915 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
44 Patients Enrolled for Obsessive-Compulsive Disorder
Butler HospitalOTHER
129 Previous Clinical Trials
16,358 Total Patients Enrolled
12 Trials studying Obsessive-Compulsive Disorder
387 Patients Enrolled for Obsessive-Compulsive Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am pregnant or not using effective birth control and am sexually active.My medication dose has been stable for the last 6 weeks with no changes expected.I am between 12 and 21 years old.I have moderate or severe OCD based on a specific test score.I am currently receiving therapy for OCD.I have not had TMS treatment in the last 3 months.I am on medication that my doctor says could increase my risk of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: ERP+iTBS
- Group 2: ERP+cTBS
- Group 3: ERP+Sham
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I meet the criteria to join this medical experiment?
"Candidates that would like to be part of this medical trial must meet two criteria: they should have obsessive-compulsive disorder and their age should range from 12 years old to 21. The study is aiming to recruit 60 participants in total."
Answered by AI
Are there any openings for participants in this clinical experiment?
"Based on the most recent update, this medical trial is not currently enrolling new patients. The study was first posted in October 1st, 2023 and altered most recently on July 3rd of the same year. However, there are over a hundred other clinical studies presently seeking participants."
Answered by AI
Is the age range for participants in this trial limited to those above 50 years of age?
"Eligibility for this trial necessitates that participants are aged between 12-21 years old. Additionally, there are 22 trials available to those younger than 18 and 68 for seniors aged 65 or older."
Answered by AI
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