Augmenting Standard-of-care Treatment of Plaque Psoriasis by Neuromodulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The human body responds to inflammation, such as psoriatic skin lesions, by activating the cholinergic anti-inflammatory pathway. In patients with plaque psoriasis, this pathway is not sufficient to clear the skin lesions. Importantly, the vagus nerve, that is part of the anti-inflammatory pathway, also innervates the ear where it can be activated through non-invasive transcutaneous auricular vagus nerve stimulation (taVNS). This raises the research question if taVNS - added to standard of care - improves the symptoms of plaque psoriasis by augmenting the function of the cholinergic anti-inflammatory pathway. Thus, the aim of this project is to test the hypothesis that daily taVNS applied for 3 months results in anti-inflammatory actions and improvements in the Psoriasis Area and Severity Index (PASI). Potential anti-inflammatory actions of taVNS compared to a sham-taVNS control group will be assessed by plasma cytokine levels, flow cytometry, and cell culture experiments. This project is potentially significant, because it may demonstrate that taVNS lessens the symptoms of plaque psoriasis and, therefore, improves the quality of life of millions of patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years or older

• Plaque psoriasis diagnosed by a dermatologist

Locations
United States
New Mexico
Burrell College of Osteopathic Medicine
RECRUITING
Las Cruces
Contact Information
Primary
Harald M Stauss, MD, PhD
hstauss@burrell.edu
575-674-2327
Time Frame
Start Date: 2022-04-26
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 50
Treatments
Experimental: Active taVNS
These patients will self-administer transcutaneous auricular vagus nerve stimulation (taVNS).
Sham_comparator: Sham taVNS
These patients will self-administer a sham procedure mimicking the active taVNS procedure.
Related Therapeutic Areas
Sponsors
Leads: Burrell College of Osteopathic Medicine

This content was sourced from clinicaltrials.gov