Neuromodulation for Plaque Psoriasis

Overseen By Harald M Stauss, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Burrell College of Osteopathic Medicine

Disqualifiers: Pregnancy, Cardiac arrhythmia, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with plaque psoriasis, a skin condition that causes red, scaly patches. It tests whether a device that stimulates a nerve in the ear (Transcutaneous Auricular Vagus Nerve Stimulation, or taVNS) can reduce inflammation and improve symptoms when used alongside usual treatments. Participants will use either the actual device or a sham version that does not provide real stimulation for comparison. Those diagnosed with plaque psoriasis by a dermatologist and willing to try this new daily treatment for three months might be a good fit.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially benefit from a novel approach to managing plaque psoriasis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it does require that you do not anticipate any changes in your medication during the 3-month study period.

What prior data suggests that this neuromodulation technique is safe for treating plaque psoriasis?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe. Studies have found that most people tolerate taVNS well, with side effects typically mild and temporary. Some individuals might experience ear pain or slight skin irritation, but these effects are short-lived. Overall, taVNS is considered a safe and promising non-invasive treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for plaque psoriasis, which typically involve topical creams, phototherapy, or systemic medications, taVNS (transcutaneous auricular vagus nerve stimulation) offers a novel approach by targeting the vagus nerve through the ear. This method is non-invasive and focuses on neuromodulation, which means it might modulate the body's immune response to reduce inflammation. Researchers are excited about taVNS because it could provide a new, drug-free option for patients, potentially with fewer side effects compared to conventional therapies. Additionally, the ease of self-administration makes it a convenient option for those seeking alternative or complementary therapies.

What evidence suggests that taVNS is effective for plaque psoriasis?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) can help reduce inflammation and improve conditions like psoriasis. One study demonstrated that using taVNS for three months lowered stress hormone levels in a psoriasis patient, supporting its potential to reduce inflammation. The treatment stimulates the vagus nerve in the ear, aiding the body in fighting inflammation. In this trial, participants will receive either active taVNS or a sham procedure that mimics the active taVNS. Although more research is needed, early findings suggest taVNS might reduce the severity of plaque psoriasis symptoms, as measured by the Psoriasis Area and Severity Index (PASI). Overall, taVNS appears to be a promising, safe, and non-invasive way to enhance current psoriasis treatments. ^{4 5 6 7 8}

Who Is on the Research Team?

Harald M Stauss, MD, PhD

Principal Investigator

Burrell College of Osteopathic Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

I have inner ear nerve damage.

Pregnancy

I have epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer taVNS or sham-taVNS daily for 3 months while continuing standard-of-care treatment

12 weeks

Baseline, 7 days, 1 month, 2 months, 3 months (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• taVNS

Trial Overview 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.

How Is the Trial Designed?

Group I: Active taVNS Experimental Treatment 1 Intervention

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

Group II: Sham taVNS Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Burrell College of Osteopathic Medicine

Lead Sponsor

Trials

6

Recruited

330+

Published Research Related to This Trial

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and effective neuromodulation therapy for a variety of conditions, including epilepsy, depression, and anxiety, indicating its broad therapeutic potential.

Despite its effectiveness, there is currently no standardization among taVNS devices, and further research is needed to clarify the relationship between stimulation parameters and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Wang, L., Wang, Y., Wang, Y., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

Transcutaneous auricular Vagus Nerve Stimulation (taVNS) can be optimized by varying electrode designs, which significantly affects the sensitivity and selectivity of nerve activation in different regions of the ear, as shown through a detailed anatomical model and finite element analysis.

The study found that smaller electrodes increase the electric field strength for a given current, allowing for more targeted stimulation of specific ear regions, which is crucial for enhancing the efficacy of taVNS in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). Kreisberg, E., Esmaeilpour, Z., Adair, D., et al.[2023]

Transcutaneous vagus nerve stimulation (tVNS) in 40 patients (20 with psoriatic arthritis and 20 with ankylosing spondylitis) showed a significant reduction in clinical disease activity and inflammatory markers, particularly a 20% decrease in CRP levels in psoriatic arthritis patients.

The treatment was well-tolerated with no reported side effects, suggesting that tVNS could be a safe and effective adjunct therapy to enhance existing treatments for these inflammatory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagal Nerve Stimulation-Modulation of the Anti-Inflammatory Response and Clinical Outcome in Psoriatic Arthritis or Ankylosing Spondylitis. Brock, C., Rasmussen, SE., Drewes, AM., et al.[2022]

Transcutaneous vagus nerve stimulation (taVNS) applied at the auricular concha significantly improved sleep quality, depression, and anxiety symptoms in 35 patients with primary insomnia over a treatment period of 4 weeks.

The treatment was found to be safe, with no adverse reactions reported, suggesting that taVNS could be a beneficial long-term intervention for managing primary insomnia and associated affective disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcutaneous vagus nerve stimulation for primary insomnia and affective disorder:a report of 35 cases]. Luo, M., Qu, X., Li, S., et al.[2018]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and well-tolerated method for treating conditions like drug-resistant epilepsy, but a recent randomized double-blind trial found no significant difference in outcomes between high- and low-stimulation groups.

The most common side effect of taVNS is a tingling sensation or pain at the stimulation site, and while it shows promise, further research is needed to fully understand its efficacy and to potentially gain approval for insurance coverage in Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical Application of Transcutaneous Auricular Vagus Nerve Stimulation]. Yamamoto, T.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improves depression symptoms, as evidenced by reduced scores on the Hamilton Depression Scale in a review of 12 studies involving 838 participants.

taVNS shows comparable response rates to traditional antidepressants and has fewer side effects, suggesting it could be a safe alternative or complementary treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. Tan, C., Qiao, M., Ma, Y., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

This study will investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on 15 patients with a minimally conscious state, using five different frequencies (1, 10, 25, 50, and 100 Hz) to determine the optimal stimulation parameters.

The goal is to achieve stable improvements in consciousness levels in patients with disorders of consciousness by optimizing the taVNS neuromodulation technique, with results measured through the coma recovery scale-revised (CRS-R) and resting EEG assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol. Zhai, W., Jiao, H., Zhuang, Y., et al.[2023]

In a study involving 26 subjects, simultaneous stimulation of the cymba and concha (CC) areas of the ear using extra-large electrodes was found to be the most effective for eliciting vagus somatosensory evoked potentials (VSEP), indicating strong neuromodulation effects.

The research demonstrated that the earlobe is not an effective target for taVNS, and using larger electrodes not only increased the amplitude of the response but also made the stimulation more comfortable for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of different vagus nerve stimulation anatomical targets in the ear by vagus evoked potential responses. de Gurtubay, IG., Bermejo, P., Lopez, M., et al.[2021]

Transcutaneous auricular vagus nerve stimulation (taVNS) effectively increases heart rate variability (HRV), indicating a shift towards parasympathetic dominance, with the most significant effects observed at the cymba conchae and fossa triangularis targets.

The study found that HRV increases in a charge-dependent manner, with optimal stimulation parameters being bursts of taVNS at a pulse duration of 100 μs and a current intensity of 2 mA, suggesting these parameters are both comfortable and effective for enhancing HRV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulation and heart rate variability: Analysis of parameters and targets. Machetanz, K., Berelidze, L., Guggenberger, R., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05243303

Augmenting Standard-of-care Treatment of Plaque ... The investigators' pilot data show that transcutaneous auricular vagus nerve stimulation (taVNS) activates afferent nerve fibers within the auricular branch ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11815478/

Transcutaneous auricular vagus nerve stimulation inhibits ... In this study, we report that chronic taVNS for 3 months lowered diurnal cortisol levels in a psoriasis patient, a finding that is consistent ...

3. withpower.com withpower.com/trial/phase-psoriasis-vulgaris-plaque-psoriasis-3-2022-87896

Neuromodulation for Plaque Psoriasis Research shows that transcutaneous auricular vagus nerve stimulation (taVNS) can help reduce inflammation and improve disease activity in conditions like ...

4. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1539416/full

A pooled analysis of the side effects of non-invasive ... These findings demonstrate a favorable safety profile of taVNS, with mostly mild and transient effects, supporting its use as a suitable non-invasive tool.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8192665/

Transcutaneous Auricular Vagus Nerve Stimulation In two early studies with small sample sizes (10 and 14 cases), taVNS treatment lasting 6–9 months effectively reduced the frequency of seizure ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9772204/

Safety of transcutaneous auricular vagus nerve stimulation ... The author concluded that transcutaneous vagus nerve stimulation is well tolerated and safe, with only mild side effects such as local skin ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11841445/

A pooled analysis of the side effects of non-invasive ... These findings demonstrate a favorable safety profile of taVNS, with mostly mild and transient effects, supporting its use as a suitable non-invasive tool.

8. ard.bmj.com ard.bmj.com/content/77/Suppl_2/1013.1

SAT0298 Transcutaneous vagus nerve stimulation in ... Transcutaneous vagus nerve stimulation may have an acute effect on cardiac vagal tone and heart rate in patients with ankylosing spondylitis and psoriatic ...