Recruiting

Neuromodulation

Sponsor:

Burrell College of Osteopathic Medicine

Code:

NCT05243303

Conditions

Psoriasis Vulgaris

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active taVNS

Sham taVNS

Study Details

Brief 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.

Conditions

Psoriasis Vulgaris

Study ID

NCT05243303

Start date

Apr 26, 2022

Status verified date

Apr, 2023

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years or older
  • Plaque psoriasis diagnosed by a dermatologist

Exclusion Criteria:

  • pregnancy
  • vestibulocochlear neuronitis or nerve damage
  • cardiac arrhythmia
  • epilepsy
  • anticipated change in medication during the 3-month study period

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Active taVNS

A bipolar clip electrode is placed at the cymba conchae of the ear. Through this bipolar clip electrode, afferent nerve fibers within the auricular branch of the vagus nerve will be stimulated. Subjects self-administer the stimulation on a daily basis for 3 months.

Sham taVNS

A bipolar clip electrode is placed at the cymba conchae of the ear. However, active stimulation of the afferent nerve fibers within the auricular branch of the vagus nerve will not occur, because the electrode wire is electrically interrupted. Subjects self-administer the sham taVNS on a daily basis for 3 months.

Primary outcome measure

  • Change in Psoriasis Area and Severity Index from Baseline at 1 Week [ Time Frame: After 1 week of treatment. ]
  • Change in Psoriasis Area and Severity Index from Baseline at 1 Month [ Time Frame: After 1 month of treatment. ]
  • Change in Psoriasis Area and Severity Index from Baseline at 2 Months [ Time Frame: After 2 months of treatment. ]
  • Change in Psoriasis Area and Severity Index from Baseline at 3 Months [ Time Frame: After 3 months of treatment. ]

Central Contacts and Locations

Central contacts

Harald M Stauss, MD, PhD

575-674-2327hstauss@burrell.edu

Locations

Burrell College of Osteopathic Medicine

Recruiting

Las Cruces, New Mexico, United States, 88001

Contacts

Harald M Stauss, MD, PhD

575-674-2327hstauss@bcomnm.org

More Information

Sponsor

Burrell College of Osteopathic Medicine

Last update posted

Jul 10, 2023

Last verified

Apr, 2023

Keywords

  • transcutaneous auricular vagus nerve stimulation
  • inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Burrell College of Osteopathic Medicine on 2023-07-10.