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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 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

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.

Find a Location

Who is running the clinical trial?

Burrell College of Osteopathic MedicineLead Sponsor
4 Previous Clinical Trials
246 Total Patients Enrolled
Harald M Stauss, MD, PhDPrincipal InvestigatorBurrell College of Osteopathic Medicine
3 Previous Clinical Trials
96 Total Patients Enrolled

Media Library

Active taVNS Clinical Trial Eligibility Overview. Trial Name: NCT05243303 — N/A
Active taVNS 2023 Treatment Timeline for Medical Study. Trial Name: NCT05243303 — N/A
Plaque Psoriasis Clinical Trial 2023: Active taVNS Highlights & Side Effects. Trial Name: NCT05243303 — N/A
Plaque Psoriasis Research Study Groups: Active taVNS, Sham taVNS
~6 spots leftby Feb 2025