RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-26
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05243303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * Plaque psoriasis diagnosed by a dermatologist
  1. * pregnancy
  2. * vestibulocochlear neuronitis or nerve damage
  3. * cardiac arrhythmia
  4. * epilepsy
  5. * anticipated change in medication during the 3-month study period

Contacts and Locations

Study Contact

Harald M Stauss, MD, PhD
CONTACT
575-674-2327
hstauss@burrell.edu

Principal Investigator

Harald M Stauss, MD, PhD
PRINCIPAL_INVESTIGATOR
Burrell College of Osteopathic Medicine

Study Locations (Sites)

Burrell College of Osteopathic Medicine
Las Cruces, New Mexico, 88001
United States

Collaborators and Investigators

Sponsor: Burrell College of Osteopathic Medicine

  • Harald M Stauss, MD, PhD, PRINCIPAL_INVESTIGATOR, Burrell College of Osteopathic Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-26
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2022-04-26
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • transcutaneous auricular vagus nerve stimulation
  • inflammation

Additional Relevant MeSH Terms

  • Psoriasis Vulgaris