Pairing tVNS and Exposure and Response Prevention to Improve Symptoms of OCD

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    56
  • sponsor
    University of Florida
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Updated on 28 October 2022
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Summary

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.

Details
Condition OCD
Treatment SHAM, tVNS
Clinical Study IdentifierNCT05580614
SponsorUniversity of Florida
Last Modified on28 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Adults between the ages of 18 and 50
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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