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Device
rTMS for Obsessive-Compulsive Disorder
N/A
Recruiting
Led By Nolan Williams, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment up to 1-month post-treatment
Awards & highlights
Summary
This trial will study how brain activity affects OCD, and test new treatments to see if they help.
Who is the study for?
This trial is for adults aged 18-80 with Obsessive-Compulsive Disorder (OCD) who have a moderate severity score and have not responded to or refused standard treatments. Participants must be able to consent, may be on stable SRI medication, and complete MRI safety screening. Exclusions include primary psychiatric diagnoses other than OCD, severe personality disorders, active suicidality, metal in the body, unstable physical conditions, drug abuse, certain neurological disorders or history of seizures.Check my eligibility
What is being tested?
The study aims to identify brain-based subtypes of OCD and assess how well two different rTMS targets—the medial prefrontal cortex (MPFC) and the right prefrontal cortex (rPFC)—work in treating symptoms. It involves non-invasive magnetic stimulation of specific brain areas.See study design
What are the potential side effects?
rTMS is generally safe but can cause discomfort at the stimulation site, headache, lightheadedness or tingling. Rarely it might induce seizures or hearing loss if ear protection isn't used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-treatment up to 1-month post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment up to 1-month post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
resting-state functional connectivity (rsFC) of frontostriatal networks
Secondary outcome measures
OCD symptoms
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Medial Prefrontal Cortex (MPFC)Experimental Treatment1 Intervention
Intermittent theta-burst stimulation (iTBS) of MPFC at up to 100% resting motor threshold (RMT), with lower extremity RMT established for the MPFC target.
Group II: Right Prefrontal Cortex (rPFC)Active Control1 Intervention
Continuous theta-burst stimulation (cTBS) of rPFC at up to 110% of RMT, with upper extremity RMT established for the rPFC target.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1170
Find a Location
Who is running the clinical trial?
Foundation for OCD ResearchUNKNOWN
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
120 Patients Enrolled for Obsessive-Compulsive Disorder
Cornell UniversityOTHER
167 Previous Clinical Trials
14,089,620 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,462,579 Total Patients Enrolled
15 Trials studying Obsessive-Compulsive Disorder
1,043 Patients Enrolled for Obsessive-Compulsive Disorder
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a device implanted or undergone brain surgery.I have a history of significant hearing loss.I have a serious brain or nerve condition.My OCD symptoms started after I turned 40.My head or neck movements interfere with certain medical scans.I have a history of brain-related health issues or a close relative with seizures.I have been diagnosed with severe Personality Disorder or was hospitalized for borderline personality disorder.My medication affecting brain activity is approved by a TMS specialist.I am between 18 and 80 years old.I have tried or refused standard OCD treatments.I have been diagnosed with OCD and it's moderately severe.I am not on antidepressants or have been on a stable dose for 8 weeks.I am not currently hospitalized.I understand and can agree to the study's procedures and risks.I plan to start or have recently started Cognitive Behavioral Therapy.I do not have any unstable health conditions.My aTBS treatment dose is over 65% of the maximum output.I have bipolar disorder or have had manic episodes.
Research Study Groups:
This trial has the following groups:- Group 1: Medial Prefrontal Cortex (MPFC)
- Group 2: Right Prefrontal Cortex (rPFC)
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.
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