Research on the Brain Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Regulating PD Motor Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-global efficiency (Eg)
研究概览
简要总结
This study is a double blind comparative study exploring the neural underpinnings of taVNS modulating PD motor deficits. We hypothesize that taVNS might improve PD motor deficits by regulating the balance between excitation and inhibition in the primary motor cortex.
详细描述
Patients in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS with the electrodes were fixed at the left earlobe . Assessments of motor symptoms and cortical activity (using Functional near-infrared spectroscopy and Transcranial magnetic stimulation) were performed two times: at baseline, one day post intervention.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) had a diagnosis of idiopathic PD according to the Movement Disorder Society Clinical Diagnostic Criteria for PD and ON-medication Hoehn and Yahr (H&Y) stage ≤2,
- •(2) had stable pharmacotherapy for PD at least one month prior to the study,
- •(3) were aged between 40 and 80,
- •(4) signed written informed consent,
- •(5) can cooperate with the testing and taVNS treatment.
排除标准
- •(1) with cognitive impairment, according to Montreal Cognitive Assessment (MOCA) < 24;
- •(2) with severe tremor or levodopa-induced dyskinesia;
- •(3) with current intake of anticholinergics or any drugs that could induce cerebral functional change;
- •(4) with taVNS contraindications;
- •(5) received VNS treatment during the past six month;
- •(6) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.
结局指标
主要结局
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-global efficiency (Eg)
时间窗: Assessed at baseline, one day post intervention
Resting state fNIRS data was preprocessed to obtain the cortical oxyhemoglobin values which indicate the cortical excitability. Based on the established cortical functional network, we calculate three typical global parameters named global efficiency (Eg) which can To evaluate the global efficiency of parallel information transmission in cortical networks.
changes in RMT values
时间窗: Assessed at baseline, one day post intervention
The individual resting motor threshold (RMT) was established as the minimum stimulus intensity required to evoke a MEP peak-to-peak amplitude of at least 0.05 mV in five of ten consecutive trials in a resting muscle.
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-Sigma
时间窗: Assessed at baseline, one day post intervention
Resting state fNIRS data was preprocessed to obtain the cortical oxyhemoglobin values which indicate the cortical excitability. Based on the established cortical functional network, we calculate three typical global parameters named small-worldness (Sigma) which can valuatable cortical network small world attributes.
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-local efficiency (Eloc)
时间窗: Assessed at baseline, one day post intervention
Resting state fNIRS data was preprocessed to obtain the cortical oxyhemoglobin values which indicate the cortical excitability. Based on the established cortical functional network, we calculate typical global parameter named local efficiency (Eloc) which can evaluate functional separation in cortical networks.
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-nodal efficiency (Ne)
时间窗: Assessed at baseline, one day post intervention
Resting state fNIRS data was preprocessed to obtain the cortical oxyhemoglobin values which indicate the cortical excitability. Based on the established cortical functional network, we calculate one nodal parameter named nodal efficiency (Ne) which can evaluate the nodal efficiency of information transmission in cortical networks.
changes in MEPs values
时间窗: Assessed at baseline, one day post intervention
Surface electromyography (sEMG) recordings from the abductor pollicis brevis (APB) muscle were obtained to record motor evoked potentials (MEPs), which underwent amplification and filtering (bandwidth 20 Hz to 2000 Hz).
changes in SICI values
时间窗: Assessed at baseline, one day post intervention
Test stimulus intensity was set according to an unconditioned MEP with an amplitude of \~1 mV. For the conditioning stimulus of SICI and ICF, 80% of RMT was used. We tested interstimulus intervals (ISIs) of 2 and 4 ms for SICI. Each ISI was repeated 10 times to calculate the average value.
changes in CSP values
时间窗: Assessed at baseline, one day post intervention
The cortical silent period (CSP) was measured by sEMG of the APB following a single TMS pulse at 130% of the RMT to the opposite PMC-UL, while participants were requested to maintain active contraction of the APB at 20% of the maximum force.
changes in ICF values
时间窗: Assessed at baseline, one day post intervention
Test stimulus intensity was set according to an unconditioned MEP with an amplitude of \~1 mV. For the conditioning stimulus of SICI and ICF, 80% of RMT was used. We tested interstimulus intervals (ISIs) of 10 and 15 ms for ICF. Each ISI was repeated 10 times to calculate the average value.
次要结局
- Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention(Assessed at baseline, one day post intervention)