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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 1 week of treatment.
Awards & highlights

Study Summary

This trial is testing whether transcutaneous auricular vagus nerve stimulation (taVNS) can help improve the symptoms of plaque psoriasis.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available slots for participants in this trial?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, which was first posted on April 26th 2022, is actively recruiting patients. Approximately 50 subjects must be found from 1 healthcare centre."

Answered by AI

What aims does this trial seek to accomplish?

"The purpose of this study is to observe the effect that a three month treatment has on participants' Psoriasis Area and Severity Index scores. Secondary outcomes include changes in Heart Rate Variability as measured through ECG recordings at 1, 2 and 3 months into the trial."

Answered by AI

How many individuals have signed up to participate in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this medical investigation, which was initially advertised on April 26th 2022, is currently recruiting participants. A total of 50 volunteers are needed from a single site."

Answered by AI

Who else is applying?

What site did they apply to?
Burrell College of Osteopathic Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Augmenting Standard-of-care Treatment of Plaque Psoriasis by Neuromodulation
2022. "Augmenting Standard-of-care Treatment of Plaque Psoriasis by Neuromodulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05243303.
All > Psoriasis > Plaque Psoriasis
~15 spots leftby Feb 2025
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