Noninvasive Vagal Nerve Stimulation for the Management of Symptoms Experienced in Multiple Sclerosis (VANISH-MS): An Open-Label Home-Based Study of taVNS and tcVNS Compared to tDCS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Participants who Complete Home-Based taVNS or tcVNS Sessions
研究概览
简要总结
Growing evidence suggests that vagal nerve stimulation (VNS) may be novel and effective in the management of the symptom burden of multiple sclerosis (MS) potentially by reducing inflammation and emotional distress, therefore improving overall well-being.
We will complete a pilot study comparing transcutaneous auricular vagus nerve stimulation (taVNS) and transcutaneous cervical vagus nerve stimulation (tcVNS) to a standard intervention of dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) as an active control. The primary outcome will be feasibility and the preliminary efficacy data concerning self-reported symptom reduction to inform the design of an intervention, and estimated power needed to complete a larger sham-controlled RCT. We will also measure heart rate variability (HRV), an easily obtained biomarker of vagus nerve stimulation (VNS), in correspondence to intervention response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25-65 years (inclusive)
- •Definite diagnosis of MS or related demyelinating disorders (e.g., Neuromyelitis Optica or NMO)
- •Stable high efficacy DMT ≥ 6 months before enrollment and throughout the trial
- •PDDS score ≤ 6 (established to be able to complete procedures)
- •SymptoMScreen Score ≥12
- •WRAT-5 ≥85
- •SDMT z-score > -3.0
- •K10 < 35
- •Stable disease activity, defined as being more than 1 month after a clinical relapse or confirmed radiologic disease activity, or more than 1 month after steroid treatment
- •Ability to use mobile devices
排除标准
- •Primary neurologic disorder other than MS and related demyelinating disorders like NMO (e.g., stroke, Parkinson's disease, spinal cord injury, intracranial mass, traumatic brain injury (TBI), epilepsy, mild cognitive impairment (MCI), or dementia), psychiatric disorders or major medical disorders (e.g., history of myocardial infarction, diabetes, thyroid disease, arrhythmia, atrial fibrillation)
- •Diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS)
- •History of vagus nerve surgery/vagotomy
- •History of diagnosed cardiovascular disease, a heart transplant, presence of permanent pacemaker implant or Left Ventricular Assist Device
- •Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, and cardiac glycosides
- •Use of SP1 inhibitor medications such as Fingolimod, Siponimod, Ozanimod, and Ponesimod
- •Nicotine use in the past 6 months (smoking/vaping)
- •Pregnant or planning pregnancy during the study period or breastfeeding
- •Seizure disorder or recent (<5 years) seizure history
- •Active ear infections or ear pathology
- •Current presence of implanted vagus nerve stimulator or any other active implanted electronic devices (e.g., pacemaker, defibrillators, cochlear implants, DBS, iVNS, etc.)
- •Presence of metal objects in the head/neck
- •Any skin disorder or skin sensitive area near stimulation locations
研究组 & 干预措施
Active DLPFC tDCS
20 daily 20-minute sessions of active tDCS.
干预措施: Remotely Supervised Transcranial Direct Current Stimulation (RS - tDCS) (Device)
Active taVNS
20 daily 60-minute sessions of active taVNS.
干预措施: Remotely Supervised Transcutaneous Auricular Vagus Nerve Stimulation (RS - taVNS) (Device)
Active tcVNS
20 daily 20-minute sessions of active tcVNS.
干预措施: Remotely Supervised Transcutaneous Cervical Vagus Nerve Stimulation (RS - tcVNS) (Device)
结局指标
主要结局
Percentage of Participants who Complete Home-Based taVNS or tcVNS Sessions
时间窗: Up to Week 4 (End of Intervention)
Assessed among participants in the taVNS or tcVNS arms only.
次要结局
- Change in Memorial Symptom Assessment Scale (MSAS) Score(Baseline, Week 4 (End of Intervention))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form Score(Baseline, Week 4 (End of Intervention))
- Change in Multiple Sclerosis Impact Scale (MSIS-29) Score(Baseline, Week 4 (End of Intervention))
- Change in Kessler Psychological Distress Scale (K10) Score(Baseline, Week 4 (End of Intervention))
- Change in PROMIS Fatigue - Short Form 7a Score(Baseline, Week 4 (End of Intervention))
- Change in PROMIS Pain Intensity - Short Form 3a Score(Baseline, Week 4 (End of Intervention))
- Change in General Anxiety Disorder (GAD-7) Score(Baseline, Week 4 (End of Intervention))
- Change in Composite Autonomic Symptom Score-31 (COMPASS-31) Score(Baseline, Week 4 (End of Intervention))
- Change in Patient Health Questionnaire (PHQ-9) Score(Baseline, Week 4 (End of Intervention))
- Change in Nine-Hole Peg Test (9HPT) Score(Baseline, Week 4 (End of Intervention))
- Change in Heart Rate Variability (HRV)(Baseline, Week 4 (End of Intervention))
- Change in SymptoMScreen Score(Baseline, Week 4 (End of Intervention))