Neuromodulation for Plaque Psoriasis

Overseen by Harald M Stauss, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Burrell College of Osteopathic Medicine

Disqualifiers: Pregnancy, Cardiac arrhythmia, Epilepsy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment taVNS for plaque psoriasis?

Research shows that transcutaneous auricular vagus nerve stimulation (taVNS) can help reduce inflammation and improve disease activity in conditions like psoriatic arthritis, which is related to plaque psoriasis. This suggests taVNS might also help manage inflammation in plaque psoriasis. ^{1 2 3 4 5}

Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe for humans, with mild and temporary side effects like ear pain, headache, and tingling. Studies show no significant risk of severe adverse events compared to controls, making it a feasible option for clinical use. ^{2 6 7 8 9}

How does the treatment for plaque psoriasis using neuromodulation differ from other treatments?

This treatment uses transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive method that applies low-intensity electrical currents to the ear to activate the vagus nerve. Unlike traditional psoriasis treatments that often involve topical creams or systemic medications, taVNS is unique because it modulates the nervous system to potentially influence immune responses, offering a novel approach to managing the condition. ^{2 4 7 10 11}

Research Team

Harald M Stauss, MD, PhD

Principal Investigator

Burrell College of Osteopathic Medicine

Eligibility Criteria

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 am 18 years old or older.

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

Exclusion Criteria

I have inner ear nerve damage.

Pregnancy

I have epilepsy.

Trial Timeline

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

Treatment Details

Interventions

• taVNS (Neuromodulation)

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.

Participant Groups

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+

Findings from Research

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 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]

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) 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]

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) 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) 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vagal Nerve Stimulation-Modulation of the Anti-Inflammatory Response and Clinical Outcome in Psoriatic Arthritis or Ankylosing Spondylitis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]

3. China pubmed.ncbi.nlm.nih.gov

[Transcutaneous vagus nerve stimulation for primary insomnia and affective disorder:a report of 35 cases]. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulation and heart rate variability: Analysis of parameters and targets. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of different vagus nerve stimulation anatomical targets in the ear by vagus evoked potential responses. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

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

9. Netherlands 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. [2023]

10. Switzerland 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). [2023]