Augmenting Standard-of-care Treatment of Plaque Psoriasis by Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Psoriasis Area and Severity Index from Baseline at 3 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients in both arms will not know in which of the two arms (active treatment or control group) they are randomized. The sham procedure is similar to the transcutaneous auricular vagus nerve stimulation (but does not involve the actual stimulation). Therefore, it is unlikely that patients are able to differentiate whether they are assigned to the control group or to the active treatment group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Plaque psoriasis diagnosed by a dermatologist
排除标准
- •pregnancy
- •vestibulocochlear neuronitis or nerve damage
- •cardiac arrhythmia
- •anticipated change in medication during the 3-month study period
结局指标
主要结局
Change in Psoriasis Area and Severity Index from Baseline at 3 Months
时间窗: After 3 months of treatment.
Clinical assessment of the severity of plaque psoriasis
Change in Psoriasis Area and Severity Index from Baseline at 1 Month
时间窗: 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
时间窗: After 2 months of treatment.
Clinical assessment of the severity of plaque psoriasis
Change in Psoriasis Area and Severity Index from Baseline at 1 Week
时间窗: After 1 week of treatment.
Clinical assessment of the severity of plaque psoriasis
次要结局
- Change in Heart Rate Variability from Baseline at 1 Week(After 1 week of treatment.)
- Change in Heart Rate Variability from Baseline at 3 Months(After 3 months of treatment.)
- Change in Plasma Cytokine Levels from Baseline at 3 Months(After 3 months of treatment.)
- Change from baseline in cytokine release from cultured leukocytes at 1 week(After 1 week of treatment.)
- Change in Heart Rate Variability from Baseline at 1 Month(After 1 month of treatment.)
- Change in Heart Rate Variability from Baseline at 2 Months(After 2 months of treatment.)
- Change in Plasma Cytokine Levels from Baseline at 2 Months(After 2 months of treatment.)
- Change from baseline in cytokine release from cultured leukocytes at 1 month(After 1 month of treatment.)
- Change in Plasma Cytokine Levels from Baseline at 1 Week(After 1 week of treatment.)
- Change in Plasma Cytokine Levels from Baseline at 1 Month(After 1 month of treatment.)
- Change from baseline in cytokine release from cultured leukocytes at 2 months(After 2 months of treatment.)
- Change from baseline in cytokine release from cultured leukocytes at 3 months(After 3 months of treatment.)