What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis, particularly those involving neuromodulation like vagus nerve stimulation (VNS), are generally associated with mild side effects such as a warm sensation, numbness, redness, itching, tingling, muscle spasm, and localized pain. Systemic therapies, including TNF-alpha inhibitors, can reduce cardiovascular risks but may cause serious infections. Phototherapy can result in burning, blistering, and an increased risk of cutaneous malignancy.

What prior FDA approvals exist?

FDA-approved treatments for plaque psoriasis include TNF-alpha inhibitors, such as etanercept, which have shown a reduction in cardiovascular events and inflammation markers. These treatments, while not directly enhancing the cholinergic anti-inflammatory pathway like taVNS, do modulate the immune response and inflammation. Other approved treatments include oral agents like methotrexate and biologics like ustekinumab, which target specific immune pathways to reduce inflammation and disease severity.

What other types of research exist?

Promising novel alternatives to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for treating plaque psoriasis include Transcranial Magnetic Stimulation (TMS) and Transcutaneous Electrical Nerve Stimulation (TENS). Both methods have shown potential in reducing inflammation and improving symptoms in various conditions, and ongoing research may further establish their efficacy for plaque psoriasis.

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Neuromodulation for Plaque Psoriasis

N/A

Recruiting

Led By Harald M Stauss, MD, PhD

Research Sponsored by Burrell College of Osteopathic Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Plaque psoriasis diagnosed by a dermatologist

Must not have

Vestibulocochlear neuronitis or nerve damage

Epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 1 week of treatment.

Summary

This trial tests whether using a device to send mild electrical signals to the ear can help reduce inflammation and improve symptoms in people with plaque psoriasis. The study focuses on patients who do not respond well to standard treatments. Researchers hope this method will enhance the body's natural anti-inflammatory response and improve patients' quality of life.

Who is the study for?

This trial is for adults with plaque psoriasis confirmed by a dermatologist. It's not suitable for individuals with inner ear nerve damage, pregnant women, those with epilepsy, anyone expecting to change medications during the study, or people with irregular heartbeats.

What is being tested?

The trial tests if non-invasive ear stimulation (taVNS) can improve plaque psoriasis when added to standard treatments. Participants will be randomly assigned to receive either active taVNS or a sham (fake) treatment daily for three months.

What are the potential side effects?

Since taVNS is non-invasive and targets the ear's vagus nerve, side effects may include local discomfort at the site of stimulation. Systemic side effects are unlikely but could involve changes in heart rate or digestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with plaque psoriasis by a skin doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have inner ear nerve damage.

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I have epilepsy.

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I have an irregular heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 1 week of treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 1 week of treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 1 week of treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+1 more

Secondary study objectives

Change from baseline in cytokine release from cultured leukocytes at 1 month

Change from baseline in cytokine release from cultured leukocytes at 1 week

Change from baseline in cytokine release from cultured leukocytes at 2 months

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active taVNSExperimental Treatment1 Intervention

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

Group II: Sham taVNSPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active taVNS

2021

N/A

~60

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Plaque Psoriasis treatments often target the immune system to reduce inflammation and slow down the overproduction of skin cells. Common treatments include topical corticosteroids, which reduce inflammation and immune response, and biologics like TNF-alpha inhibitors, which block specific immune system proteins involved in inflammation. The cholinergic anti-inflammatory pathway, activated by the vagus nerve, is another mechanism being explored. Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) aims to enhance this pathway, potentially reducing inflammation and improving symptoms. This matters for patients as it offers a non-invasive treatment option that could complement existing therapies and improve quality of life.