Pilot, Effect of Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) on Post-Treatment Lyme Disease Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Horowitz Lyme-Multiple Systemic Infectious Disease Syndrome Questionnaire
研究概览
简要总结
This study is to assess if respiratory-gated auricular vagal nerve stimulation (RAVANS) can improve symptoms of post-treatment Lyme disease syndrome
详细描述
Lyme disease is caused by the tick-borne spirochete bacteria Borrelia burgdoferi and is the most common vector borne illness in the US. A subset of individuals with confirmed Lyme disease go on to experience persistent fatigue, pain, and/or neurocognitive difficulties after treatment that are of sufficient severity to impact quality of life and physical functioning. This chronic condition has since been termed post-treatment Lyme disease syndrome (PTLDS). The cause of PTLDS is not known and currently there are no recommended treatments.
We have hypothesized that some cases of PTLDS may be caused by an infection or inflammatory process on or near the neuroimmune vagus nerve, which communicates the detection of peripheral inflammation to the central nervous system and triggers the sickness response circuitry.
Increasing evidence shows that transcutaneous auricular nerve stimulation (taVNS) can significantly reduce multiple symptoms of stress disorder including depression, cognitive impairment, psychomotor retardation, sleep disturbance. Respiratory-gated auricular vagal afferent nerve stimulation(RAVANS), a type of taVNS, which synchronizes stimulation to the respiratory cycle, modulate vagal systems and optimize stimulations and has been shown beneficial effect in pain management.
In this study, we will conduct a randomized, double blinded, sham-controlled pilot study to explore the effect of RAVANS on the symptoms in individuals diagnosed with PTLDS using psychometric measurement, function and cognitive test, and serum biomarkers.
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
- Double (Participant, Outcomes Assessor)
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
- •Adults of all genders ≥ 18 years
- •History of Lyme disease treated with antibiotics, and current PTLDS diagnosed by a physician
- •Evidence of past B. burgdorferi infection based on positive results from both enzyme immunoassay and Western blot testing.
- •Ability to provide informed consent,
- •willing to maintain current PTLDS treatment regimen during participation in the study (if on long-term antibiotics or supplements for PTLDS management).
排除标准
- •History of other neurological disorder that in the judgement of the investigator could interfere with the treatment or the interpretation of the results (e.g., epilepsy, history of stroke, tumor, brain tissue damaging pathologies etc.).
- •Current psychotic disorder (e.g., schizophrenia).
- •Current acute illness or infection (e.g. cold or flu).
- •Current or past history of psychiatric illness; PTSD, depression and anxiety are exclusion criteria only if the conditions are so severe as to have required hospitalization in the past 5 years.
- •History of recurrent vaso-vagal syncope
- •Bradycardia defined as resting heart rate <50bpm
- •Implanted electronic device (e.g., pacemaker, neurostimulator)
- •Use of immunosuppressive medication such as prednisone, TNF medications within 2 weeks of the visit or anticipated use during the study.
- •Current use of anti-inflammatory steroid use.
研究组 & 干预措施
RAVANS
active RAVANS, 20 minutes each treatment, 3 times per week for 2 weeks
干预措施: respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) (Device)
Sham stimulation
Sham-stimulation, 20 minutes each treatment, 3 times per week for 2 weeks
干预措施: Sham RAVANS (Device)
结局指标
主要结局
Horowitz Lyme-Multiple Systemic Infectious Disease Syndrome Questionnaire
时间窗: Before treatment (baseline) and Post treatment ( at the end of 2-week treatment)
This 55-item questionnaire evaluates the frequency, severity, and incidence of Lyme symptoms as well as assessing one's perceived overall health. Minimum value:0 Maximum value: 114 The higher number indicates more symptoms
次要结局
- Sedentary Behaviors Questionnaire(Before treatment (baseline) and Post treatment (at the end of 2-week treatment))
- Fatigue Symptom Inventory(Before treatment (baseline) and Post treatment (at the end of 2-week treatment))
- Brief Pain Inventory-Pain 24 Hours(Before treatment (baseline) and Post treatment (at the end of 2-week treatment))
- Beck Depression Inventory(Before treatment (baseline) and Post treatment (at the end of 2-week treatment))
- Beck Anxiety Inventory(Before treatment (at baseline) and after treatment (at the end of 2-week treatment))
- Pittsburgh Sleep Quality Index(Before treatment (baseline) and Post treatment (at the end of 2-week treatment))
- Timed Up and Go(Before treatment ( baseline) and Post treatment (at the end of 2-week treatment))
- Time to Complete 4 Meters at Usual Walking Speed,(Before treatment (baseline) and Post treatment (at the end of 2-week treatment))
- NIH Toolbox Cognition Battery (NIHTB-CB)(Before treatment (at baseline) and Post treatment (at the end of 2-week treatment))
- Serum Level of Inflammatory Cytokines-IL6(Before treatment (baseline) and Post treatment (at the end of 2-week treatment))
- Serum Level of Inflammatory Cytokines-IL10(Before treatment (at baseline) and after treatment (at the end of 2-week treatment))
- Serum Level of Inflammatory Cytokines-TNF Alfa(Before treatment (baseline) and Post treatment (at the end of 2-week treatment))
研究者
Qing Mei Wang, M.D.
Director, Stroke Biological Recovery Laboratory
Spaulding Rehabilitation Hospital