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Transcranial Magnetic Stimulation
Accelerated Theta-Burst Stimulation for Obsessive-Compulsive Disorder
N/A
Recruiting
Led By Ian Kratter, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capacity to provide informed consent
Meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OCD with a moderate level of severity as defined by a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 18
Must not have
Age of OCD symptom onset >30
History of receiving Electroconvulsive Therapy (ECT) (assessed during baseline by study MD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pretreatment) to immediate post-treatment follow up
Awards & highlights
Summary
This trial will test if an accelerated schedule of theta-burst stimulation using a TMS device can help people with OCD who haven't responded to other treatments.
Who is the study for?
This trial is for adults with moderate to severe OCD who haven't responded well to standard treatments like SRIs or cognitive behavioral therapy. Participants must be stable on SRI medication for at least 8 weeks and able to undergo study procedures. Excluded are those with substance abuse issues, severe depression, bipolar disorder, eating disorders, certain medical conditions like seizures or brain injuries, pregnant or nursing women, and anyone planning CBT during the study.
What is being tested?
The trial tests an accelerated form of Transcranial Magnetic Stimulation (TMS) called theta-burst stimulation in two different brain areas: the dorsomedial prefrontal cortex (DMPFC) and the right orbitofrontal cortex (rOFC). Participants will be randomly assigned to receive treatment at one of these sites.
What are the potential side effects?
Potential side effects from TMS may include discomfort at the stimulation site, headache, lightheadedness, tingling or spasms in facial muscles. Rarely it can cause seizures. Most side effects are mild and temporary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand and can agree to the study's procedures and risks.
Select...
I have been diagnosed with OCD and it's moderately severe.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My OCD symptoms started after I turned 30.
Select...
I have undergone Electroconvulsive Therapy.
Select...
I have had an implanted device or psychosurgery.
Select...
I have a history of brain-related health issues or a close relative with seizures.
Select...
My depression is not severe based on my last HDRS-17 score.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pretreatment) to immediate post-treatment follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pretreatment) to immediate post-treatment follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage change in Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Secondary study objectives
Percent change in the Obsessive-Compulsive Inventory-Revised (OCI-R)
Trial Design
2Treatment groups
Active Control
Group I: right OFCActive Control1 Intervention
This arm will receive continuous theta-burst stimulation to the right OFC site.
Group II: bilateral DMPFCActive Control1 Intervention
This arm will receive intermittent theta-burst stimulation to bilateral DMPFC site.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,214 Total Patients Enrolled
15 Trials studying Obsessive-Compulsive Disorder
1,223 Patients Enrolled for Obsessive-Compulsive Disorder
Ian Kratter, MD, PhDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
90 Total Patients Enrolled
Nolan Williams, MDPrincipal InvestigatorStanford University
17 Previous Clinical Trials
1,102 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
360 Patients Enrolled for Obsessive-Compulsive Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an eating disorder.I have been diagnosed with bipolar disorder recently.My OCD symptoms started after I turned 30.I have been taking the same SRI medication for at least 8 weeks and plan to continue during the study.I have undergone Electroconvulsive Therapy.I understand and can agree to the study's procedures and risks.I have tried or refused standard OCD treatments like SRI or therapy.I have been diagnosed with OCD and it's moderately severe.I have had an implanted device or psychosurgery.I am starting or have recently started Cognitive Behavioral Therapy.I have a history of brain-related health issues or a close relative with seizures.I have not tested positive for illegal drugs, except for prescribed meds or coca tea.My depression is not severe based on my last HDRS-17 score.I can handle the procedures involved in the study.You are physically able to undergo all necessary tests and procedures for the study.You are currently feeling extremely sad or having thoughts of hurting yourself.
Research Study Groups:
This trial has the following groups:- Group 1: right OFC
- Group 2: bilateral DMPFC
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.
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT04286126 — N/A
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