NCT05580614 · University of Florida
Paired tVNS With ERP in OCD
What this study is about
In the proposed investigation, the investigator will develop pilot data for the use of tVNS (transcutaneous vagal nerve stimulation) to enhance effectiveness of exposure and response prevention therapy (ERP) to improve treatment success in patients with OCD.
View original scientific description
In the proposed investigation, the investigator will develop pilot data for the use of tVNS (transcutaneous vagal nerve stimulation) to enhance efficacy of exposure and response prevention therapy (ERP) to improve treatment success in patients with OCD. This data will include tolerability information from therapists and patients with OCD, effect sizes on real world clinical outcomes for the combinatory treatment, and mechanistic data on brain changes associated with treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults between the ages of 18 and 55
- Meet DSM-5 criteria for OCD, based on a structured clinical interview and who have a YBOCS score of 15 or higher, indicating at least moderate OCD severity
- Participants must be willing and able to provide informed consent.
Exclusion criteria
- Participants with major neurological conditions, autism spectrum disorder, psychosis, major uncorrected sensory deficit, and severe medical disease that may be associated with neurological effects.
- People with an active eating disorder that requires treatment, but we will not exclude people who are in remission.
- Current illicit or prescription drug abuse
- Participants who are receiving pharmacotherapy for their OCD or for other psychiatric disorders will not be excluded
- No medication changes will be allowed during the study, and participants must be on stable doses of medications for at least 6 weeks prior to entering the study. Prior ERP treatment (at least 12 months removed) is acceptable
Where
- Gainesville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations