Understanding the Effects of Non-invasive Transauricular Vagus Nerve Stimulation (taVNS) on Neural Networks and Autonomic Nervous System: a Randomized Double-blind Sham-control Mechanistic Trial in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Resting-state Electroencephalogram (EEG)
研究概览
简要总结
This trial aims to perform an exploratory, mechanistic, randomized double-blind sham-control trial in healthy participants to assess the physiologic effects of a single 60 minutes session of bilateral taVNS, on neural networks and autonomic function.
详细描述
Several studies have shown promising results of taVNS to treat various disorders such as depression, anxiety, Alzheimer's disease, headache, obesity, and diabetes. However, no mechanistic studies have investigated the taVNS neural network and autonomic nervous system effects of this technique. Therefore, we aim to assess how taVNS can affect EEG metrics and HRV and assess its safety. Also, we aim to evaluate predictors that can influence the response to taVNS, so understanding the variables associated with response to taVNS can help the design of future clinical trials to maximize the effects of this intervention.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide informed consent to participate in the study.
- •Subject is older than 18 years.
- •Subjects should be naive to the stimulation (taVNS)
排除标准
- •Subjects who have had a neuropsychiatric or a cardiac disorder diagnosis and have received treatment and chronic medication in the past six months, or who have functional deficits as a result.
- •History of alcohol or drug abuse within the past 6 months as self-reported.
- •Presence of the following contraindication to transauricular vagus nerve stimulation
- •Ferromagnetic metal in the head and in the cranium (e.g., plates or pins, bullets, shrapnel)
- •Implanted cranial electronic medical devices (e.g., cochlear implants)
- •Implanted cardiac devices (e.g., pacemaker)
- •Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, or chronic obstructive pulmonary disease).
- •Uncontrolled epilepsy, as defined by previous clinical seizures in the past 3 months in patients with treatment for epilepsy.
- •Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).
研究组 & 干预措施
Active taVNS
TaVNS will be administered by an earset, with conductive eartips placed on the auricular concha of the ears, connected to a stimulator, and during active stimulation, we stimulate both the cymba conchae and external auditory canal of both left and right ears with the following parameters: 30Hz, 200-250 us, and with adjustable intensity for 60 min.
干预措施: Transauricular vagus nerve stimulation (taVNS) (Device)
Sham taVNS
Sham condition will have the same device, with an earset, and conductive eartips placed in the same location of the active stimulation; however during 60 min there will be no current and the device will be turned off.
干预措施: Transauricular vagus nerve stimulation (taVNS) (Device)
结局指标
主要结局
Resting-state Electroencephalogram (EEG)
时间窗: Change from baseline to 60 minutes post-intervention.
Resting-state EEG was recorded using a 64-channel high-density EGI system (Electrical Geodesics, Inc., Eugene, USA) under the eyes closed condition. Data was filtered into standard frequency bands using short-time Fourier transformation (STFT): delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-80 Hz). Frontal asymmetry was computed as the difference in power between homologous left and right frontal electrodes (e.g., F3-F4) in the alpha band.
Conditioned Pain Modulation (CPM) Response - Change in Pain Ratings on the Pain-6 Scale (0-10)
时间窗: Change from baseline to 60 minutes post-taVNS.
Pain intensity was measured using the Numeric Pain Scale (NPS; 0 = no pain, 10 = worst pain). Higher scores indicate worse pain. A "pain-6 temperature" was first identified (temperature that elicits NPS = 6). Test stimulus: Pain-6 temperature applied for 30s; participants rated pain at 10, 20, and 30s. The test-stimulus score is the average of the three NPS ratings. Conditioned stimulus: After 5 minutes, the left hand was immersed in 10-12°C water for 30s while the same pain-6 temperature was applied again. Pain was rated the same way, and the conditioned-stimulus score is the average of the three NPS ratings. CPM calculation = (test-stimulus average) - (conditioned-stimulus average). Positive values = better endogenous pain inhibition; negative values = worse.
次要结局
- Heart Rate Variability (HRV)(Post-intervention (after 60 minutes of taVNS))
研究者
Felipe Fregni, MD, PhD, MPH
Director of Spaulding Neuromodulation Center
Spaulding Rehabilitation Hospital