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

NCT05243303 | Recruiting FDA Device

• 1 other identifier: 0090_2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

transcutaneous auricular vagus nerve stimulation; inflammation

Outcome Measures

Primary Outcomes (4)

• Change in Psoriasis Area and Severity Index from Baseline at 1 Week

  Clinical assessment of the severity of plaque psoriasis

  After 1 week of treatment.

• Change in Psoriasis Area and Severity Index from Baseline at 1 Month

  Clinical assessment of the severity of plaque psoriasis

  After 1 month of treatment.

• Change in Psoriasis Area and Severity Index from Baseline at 2 Months

  Clinical assessment of the severity of plaque psoriasis

  After 2 months of treatment.

• Change in Psoriasis Area and Severity Index from Baseline at 3 Months

  Clinical assessment of the severity of plaque psoriasis

  After 3 months of treatment.

Secondary Outcomes (12)

• Change in Heart Rate Variability from Baseline at 1 Week

  After 1 week of treatment.

• Change in Heart Rate Variability from Baseline at 1 Month

  After 1 month of treatment.

• Change in Heart Rate Variability from Baseline at 2 Months

  After 2 months of treatment.

• Change in Heart Rate Variability from Baseline at 3 Months

  After 3 months of treatment.

• Change in Plasma Cytokine Levels from Baseline at 1 Week

  After 1 week of treatment.

Study Arms (2)

Active taVNS

EXPERIMENTAL

These patients will self-administer transcutaneous auricular vagus nerve stimulation (taVNS).

Device: Active taVNS

Sham taVNS

SHAM COMPARATOR

These patients will self-administer a sham procedure mimicking the active taVNS procedure.

Device: Sham taVNS

Interventions

Active taVNS DEVICE

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.

Also known as: active transcutaneous auricular vagus nerve stimulation

Active taVNS

Sham taVNS DEVICE

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.

Also known as: sham transcutaneous auricular vagus nerve stimulation

Sham taVNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Plaque psoriasis diagnosed by a dermatologist

You may not qualify if:

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

Sponsors & Collaborators

• Burrell College of Osteopathic Medicine: lead

Study Sites (1)

Burrell College of Osteopathic Medicine

Las Cruces, New Mexico, 88001, United States

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harald M Stauss, MD, PhD

  Burrell College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harald M Stauss, MD, PhD

CONTACT

575-674-2327; hstauss@burrell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients in both arms will not know in which of the two arms (active treatment or control group) they are randomized. The sham procedure is similar to the transcutaneous auricular vagus nerve stimulation (but does not involve the actual stimulation). Therefore, it is unlikely that patients are able to differentiate whether they are assigned to the control group or to the active treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with plaque psoriasis will be randomized in one of two groups: (1) Active treatment group. These patients will receive daily transcutaneous auricular vagus nerve stimulation for 3 months; (2) Control group. These patients will receive a sham procedure instead of the transcutaneous auricular vagus nerve stimulation.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 17, 2022
• Study Start: April 26, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2026
• Last Updated: July 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)