Paired tVNS With ERP in OCD

OCD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580614
• Other study ID #: IRB202101733
• Secondary ID: OCR41263
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: Jennifer DeHart
• Phone: 352-316-7154
• Email: jdehart[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• OCD

Intervention

Device:
• Sham
MRI (Magnetic Resonance Imaging) paired ERP/Sham YBOCs(Yale-Brown Obsessive Compulsive Scale) (4,8,12) OCI-R (every other session). YBOCs and OCI-R will also be administered at intake and 4 weeks post treatment.
• tVNS
MRI (Magnetic Resonance Imaging) paired ERP/tVNS YBOC's (Yale-Brown Obsessive Compulsive Scale) (4, 8, 12) OCI-R (every other session). YBOCs and OCI-R will also be administered at intake and 4 weeks post treatment.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	International OCD Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Brown Obsessive-Compulsive Scale (Y-BOCS)	A test to rate the severity of obsessive-compulsive disorder (OCD) symptoms. The 10 Y-BOCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions, and the sum of the last five an index for compulsions. Total scores on the measure range from 0 to 40, with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms. The scale can also provide a subscale score for obsessions and compulsions (range 0-20) separately.	Baseline up to 1 month post treatment