A Pilot Feasibility Study of Vagustim™ Transcutaneous Auricular Vagus Nerve Stimulation Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Serum TNF
研究概览
简要总结
Transcutaneous auricular vagus nerve stimulation (taVNS) has become a therapy of interest for treating chronic immune-medicated illnesses in adults and children. Vagustim™ taVNS devices are commercially available devices that have been used in clinical and non-clinical studies examining inflammatory conditions. Previous work of the investigative team has utilized TENS devices from Roscoe Medical to deliver stimulation. We aim to evaluate Vagustim™'s sham stimulation method as a placebo for clinical trials.
详细描述
This study will be a double-blind, sham-controlled trial with 20 participants evaluating Vagustim™'s sham method as a placebo. Participants will be randomized to the active treatment group or the sham treatment group and undergo a one-time 10-minute taVNS treatment. Blood samples will be obtained immediately prior to treatment and two hours post-treatment to evaluate circulating cytokine levels. Participants will have blood samples obtained immediately prior to taVNS and two hours post-treatment. A one-time taVNS treatment will be performed with the assistance of an unblinded research coordinator. The investigator will not be present during treatment to ensure double blinding. Blood samples will be sent for cytokine testing.
The Vagustim™ Individual Device is a 134mm x 70mm x 25 mm device that provides targeted vagus nerve stimulation via an in-ear or clip-on electrode. Please see below for exact pulse stimulation parameters and programming:
- Waveform: Symmetrical biphasic rectangular waveform.
- Frequency Range: Adjustable from 1 Hz to 100 Hz.
- Pulse Width: Configurable between 50 µs and 1000 µs.
- Intensity: Adjustable up to 10 mA with fine-tuned increments for patient-specific needs.
- Stimulation Modes: Bilateral (both ears) or unilateral (one ear) stimulation.
- Power Supply: Operates on 2xAA batteries for portability and reliability.
- Connectivity: Bluetooth Low Energy 4.2 for seamless app integration.
- Construction: Durable materials suitable for repeated professional use in clinical environments.
- Duration of implant or exposure: 10 minutes
- Frequency of exposure: Once during study visit
Participants are randomized (1:1) using REDCap as used by the Biostatistics randomization team, , a web-based HIPAA compliant software package. A stratified blocked randomization will be utilized based on age in order to ensure a similar age distribution in each arm of the study (sham and active treatment). The trial will be double blinded to the investigators and participants. To avoid potential bias, the randomizer(s) at each site cannot be physicians who will conduct physical exams to evaluate study participants or members of the research team who will have contact with the study data. There will be one to two designated trainers who will distribute the intervention device based on randomization assignment in a blinded fashion. As the trainer may be able to determine who is in the working device group from the reaction of the participant, this trainer will be independent (not an investigator) and will not have access to study related data/outcomes or be involved in the analysis. Unblinding will occur after all participants have completed their study visits.
taVNS Group: The intensity setting for pulse amplitude will be adjusted to the participant's tolerance (if a sensation is felt) This will involve slowly and incrementally increasing the intensity until the patient states they feel the electrical stimulation.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •Age greater than or equal to 18 years
- •Capable of giving informed consent or have an acceptable surrogate capable of giving consent on the participant's behalf.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
排除标准
- •Participants or guardians who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- •Any known inflammatory condition (e.g., SLE) or other chronic condition including kidney disease (exceptions: temporary urinary conditions, including urinary tract infection (UTI), microscopic hematuria, etc. )
- •History of cardiac disease (arrhythmias, structural/functional abnormalities).
- •Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants, or deep brain stimulators).
- •Chronic rash or skin breakdown of the left ear at the cymba concha.
- •Pregnancy or breast feeding.
结局指标
主要结局
Serum TNF
时间窗: T=0 and T=2 hours after treatment
Serum TNF will be measured as a response to treatment with taVNS while the sham group will maintain similar levels throughout the study period.
次要结局
未报告次要终点