Psoriasis VulgarisNCT05243303
Augmenting Standard-of-care Treatment of Plaque Psoriasis by Neuromodulation
A study testing Active taVNS in people with Psoriasis Vulgaris, run by Burrell College of Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2022to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Plaque psoriasis diagnosed by a dermatologist
Who cannot join
- pregnancy
- vestibulocochlear neuronitis or nerve damage
- cardiac arrhythmia
- epilepsy
- anticipated change in medication during the 3-month study period
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Burrell College of Osteopathic Medicine
Las Cruces, New Mexico, 88001
Harald M Stauss, MD, PhD, 575-674-2327, hstauss@bcomnm.org
About this study
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.
Read the detailed description
An estimated 20% of psoriasis patients experience treatment failure. Afferent vagal nerve fibers that are part of the anti-inflammatory reflex sense inflammation, such as psoriatic skin lesions. The investigators' pilot data show that transcutaneous auricular vagus nerve stimulation (taVNS) activates afferent nerve fibers within the auricular branch of the vagus nerve to trigger anti-inflammatory reflex responses in healthy individuals. However, it is unknown if taVNS improves plaque psoriasis through the anti-inflammatory reflex. The lack of studies on taVNS in plaque psoriasis constitutes a missed opportunity to reduce treatment failures.
The long-term goal of this research is to establish a neuromodulatory approach to activate the anti-inflammatory reflex in patients with plaque psoriasis to lessen treatment failures. The objective of this study is to test the hypothesis that taVNS elicits anti-inflammatory reflex responses and reduces the severity of plaque psoriasis.
In a single-blinded randomized controlled clinical trial, participants will self-administer taVNS or sham-taVNS (control) daily for a duration of 3 months, while continuing their standard-of-care treatment. At baseline, 7 days, and 1, 2, and 3 months, clinical , autonomic, and inflammatory responses will be assessed.
At the conclusion of this study, the investigators expect to demonstrate anti-inflammatory reflex responses to taVNS and reduced severity of plaque psoriasis. These outcomes are expected to have important positive impact, because they are anticipated to reduce treatment failures in patients with plaque psoriasis.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Active taVNS, Sham taVNS
- Keywords
- transcutaneous auricular vagus nerve stimulation, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active taVNSDevice
Also called active transcutaneous auricular vagus nerve stimulation
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 taVNSDevice
Also called sham transcutaneous auricular vagus nerve stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS | Experimental | These patients will self-administer transcutaneous auricular vagus nerve stimulation (taVNS). Receives: Device: Active taVNS |
| Sham taVNS | Sham comparator | These patients will self-administer a sham procedure mimicking the active taVNS procedure. Receives: Device: Sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psoriasis Area and Severity Index from Baseline at 1 Week
Clinical assessment of the severity of plaque psoriasis
Measured: 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
Measured: 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
Measured: 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
Measured: After 3 months of treatment.
Secondary outcomes (12)
Change in Heart Rate Variability from Baseline at 1 Week
Heart rate variability will be determined from ECG recordings
Measured: After 1 week of treatment.
Change in Heart Rate Variability from Baseline at 1 Month
Heart rate variability will be determined from ECG recordings
Measured: After 1 month of treatment.
Change in Heart Rate Variability from Baseline at 2 Months
Heart rate variability will be determined from ECG recordings
Measured: After 2 months of treatment.
Change in Heart Rate Variability from Baseline at 3 Months
Heart rate variability will be determined from ECG recordings
Measured: After 3 months of treatment.
Change in Plasma Cytokine Levels from Baseline at 1 Week
Plasma concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be determined from blood samples.
Measured: After 1 week of treatment.
Change in Plasma Cytokine Levels from Baseline at 1 Month
Plasma concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be determined from blood samples.
Measured: After 1 month of treatment.
Change in Plasma Cytokine Levels from Baseline at 2 Months
Plasma concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be determined from blood samples.
Measured: After 2 months of treatment.
Change in Plasma Cytokine Levels from Baseline at 3 Months
Plasma concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be determined from blood samples.
Measured: After 3 months of treatment.
Change from baseline in cytokine release from cultured leukocytes at 1 week
Cytokine concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be measured in supernatant from LPS-stimulated leukocyte cultures.
Measured: After 1 week of treatment.
Change from baseline in cytokine release from cultured leukocytes at 1 month
Cytokine concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be measured in supernatant from LPS-stimulated leukocyte cultures.
Measured: After 1 month of treatment.
Change from baseline in cytokine release from cultured leukocytes at 2 months
Cytokine concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be measured in supernatant from LPS-stimulated leukocyte cultures.
Measured: After 2 months of treatment.
Change from baseline in cytokine release from cultured leukocytes at 3 months
Cytokine concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be measured in supernatant from LPS-stimulated leukocyte cultures.
Measured: After 3 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start26 Apr 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burrell College of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harald M Stauss, MD, PhD, Principal investigator, Burrell College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243303
- Sponsor's protocol ID
- 0090_2021
- Status last verified
- Apr 2023
- First submitted
- 4 Feb 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Standard-of-care Treatment of Plaque Psoriasis by Neuromodulation
- ClinicalTrials.gov ID
- NCT05243303
- Acronym / sponsor ID
- 0090_2021
- Conditions
- Psoriasis Vulgaris
- Keywords
- transcutaneous auricular vagus nerve stimulation, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Burrell College of Health SciencesUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An estimated 20% of psoriasis patients experience treatment failure. Afferent vagal nerve fibers that are part of the anti-inflammatory reflex sense inflammation, such as psoriatic skin lesions. The investigators' pilot data show that transcutaneous auricular vagus nerve stimulation (taVNS) activates afferent nerve fibers within the auricular branch of the vagus nerve to trigger anti-inflammatory reflex responses in healthy individuals. However, it is unknown if taVNS improves plaque psoriasis through the anti-inflammatory reflex. The lack of studies on taVNS in plaque psoriasis constitutes a missed opportunity to reduce treatment failures.
The long-term goal of this research is to establish a neuromodulatory approach to activate the anti-inflammatory reflex in patients with plaque psoriasis to lessen treatment failures. The objective of this study is to test the hypothesis that taVNS elicits anti-inflammatory reflex responses and reduces the severity of plaque psoriasis.
In a single-blinded randomized controlled clinical trial, participants will self-administer taVNS or sham-taVNS (control) daily for a duration of 3 months, while continuing their standard-of-care treatment. At baseline, 7 days, and 1, 2, and 3 months, clinical , autonomic, and inflammatory responses will be assessed.
At the conclusion of this study, the investigators expect to demonstrate anti-inflammatory reflex responses to taVNS and reduced severity of plaque psoriasis. These outcomes are expected to have important positive impact, because they are anticipated to reduce treatment failures in patients with plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active taVNS | Experimental | Device: Active taVNSThese patients will self-administer transcutaneous auricular vagus nerve stimulation (taVNS). |
| Sham taVNS | Sham comparator | Device: Sham taVNSThese patients will self-administer a sham procedure mimicking the active taVNS procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Plaque psoriasis diagnosed by a dermatologist
Key exclusion criteria (5 listed)
- pregnancy
- vestibulocochlear neuronitis or nerve damage
- cardiac arrhythmia
- epilepsy
- anticipated change in medication during the 3-month study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active taVNSAlso: active transcutaneous auricular vagus nerve stimulationA 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. | Device | Active taVNS |
| Sham taVNSAlso: sham transcutaneous auricular vagus nerve stimulationA 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. | Device | Sham taVNS |
Primary outcome
Change in Psoriasis Area and Severity Index from Baseline at 1 Week
Time frame: After 1 week of treatment.
Clinical assessment of the severity of plaque psoriasis
Change in Psoriasis Area and Severity Index from Baseline at 1 Month
Time frame: After 1 month of treatment.
Clinical assessment of the severity of plaque psoriasis
Change in Psoriasis Area and Severity Index from Baseline at 2 Months
Time frame: After 2 months of treatment.
Clinical assessment of the severity of plaque psoriasis
Change in Psoriasis Area and Severity Index from Baseline at 3 Months
Time frame: After 3 months of treatment.
Clinical assessment of the severity of plaque psoriasis
12 secondary outcomes
Change in Heart Rate Variability from Baseline at 1 Week
Time frame: After 1 week of treatment.
Change in Heart Rate Variability from Baseline at 1 Month
Time frame: After 1 month of treatment.
Change in Heart Rate Variability from Baseline at 2 Months
Time frame: After 2 months of treatment.
Change in Heart Rate Variability from Baseline at 3 Months
Time frame: After 3 months of treatment.
Change in Plasma Cytokine Levels from Baseline at 1 Week
Time frame: After 1 week of treatment.
Change in Plasma Cytokine Levels from Baseline at 1 Month
Time frame: After 1 month of treatment.
Change in Plasma Cytokine Levels from Baseline at 2 Months
Time frame: After 2 months of treatment.
Change in Plasma Cytokine Levels from Baseline at 3 Months
Time frame: After 3 months of treatment.
Change from baseline in cytokine release from cultured leukocytes at 1 week
Time frame: After 1 week of treatment.
Change from baseline in cytokine release from cultured leukocytes at 1 month
Time frame: After 1 month of treatment.
Change from baseline in cytokine release from cultured leukocytes at 2 months
Time frame: After 2 months of treatment.
Change from baseline in cytokine release from cultured leukocytes at 3 months
Time frame: After 3 months of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald M Stauss, MD, PhD principal investigator
Burrell College of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active taVNS in people with Psoriasis Vulgaris, run by Burrell College of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harald M Stauss, MD, PhD (575-674-2327, hstauss@burrell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psoriasis Area and Severity Index from Baseline at 1 Week (time frame: After 1 week of treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.