Effect of Transcutaneous Auricular Vagus Nerve Stimulation at 25Hz and 100Hz on Levodopa Responsive and Non-responsive Gait Characteristics in Parkinson's Disease- a Motion Sensor Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Anticipatory Postural Adjustment (APA) duration
研究概览
简要总结
In this randomised placebo-controlled trial, the investigators will include 30 PD (Parkinson's disease) patients with HY (Hoehn Yahr stage) >2 and L-dopa unresponsive gait characteristics. Each participant will receive taVNS at 25Hz, taVNS at 100Hz and sham VNS (sVNS). During each stimulation, different gait characteristics will be measured with wearable insertion motion sensors.
详细描述
Participants and study overview:
In this randomised placebo-controlled trial, the investigators will include 30 PD patients with HY>2 and L-dopa unresponsive gait characteristics. Each participant will complete 1 visit, during which the instrumented stand and walk test will be repeated 16 times. The baseline measurement will be followed by three different stimulation conditions sham VNS (sVNS), taVNS at 25Hz (taVNS25) and taVNS a 100Hz (taVNS100). sVNS, taVNS25 and taVNS100 in a randomized order. To enhance gait disturbances, the participants will perform iSAW during each condition twice in silence and twice while simultaneously performing calculations around.
Instrumented stand and walk test (iSAW):
To perform iSAW, participants will first stand still for 30s, after which they will start walking in a straight line for 7m, turn and walk back to the start. The participants will be equipped with 6 inertion Opal ® motion sensors (on both feet, both wrists, on the lumbar back and on their sternum). For the laud counting iSAW condition (iSAW-C), the participants will perform iSAW as described above while also counting backwards by 3 from numbers above 100.
TaVNS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Noninvasive electrostimulation will be applied to the left ear. taVNS will be applied to the cyma conchae and sVNS will be applied to the earlobe - participants will not be told which is the active and which is the sham condition. Both taVNS and sVNS were applied through the Nemos® electrode. The intensity for each separate stimulation will be adjusted for each participant at the beginning of the experiment. For each condition, the electrode will be placed in the ear by a third person and the ear will be covered by cotton pads and an EEG cap to hide the electrode position from the experimenter. The order of stimulation will not be revealed until the automated data and statistical analysis.
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
- •HYstage >2
- •L-dopa unresponsive gait characteristics present, preferably with history of freezings
排除标准
- •unable to walk for 50m
- •unable to follow simple commands due to hearing loss/cognitive impairment
结局指标
主要结局
Anticipatory Postural Adjustment (APA) duration
时间窗: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average duration of anticipatory postural adjustments in seconds as produced by the Mobility Lab software.
APA First step Duration
时间窗: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average duration of the first detected step in seconds as produced by the Mobility Lab software.
Arm Range of Motion
时间窗: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average wrist range of motion in degrees as produced by the Mobility Lab software.
Gait Speed
时间窗: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average speed of gait in m/s as produced by the Mobility Lab software.
APA First Step range of motion
时间窗: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average range of motion of the first detected step as produced by the Mobility Lab software.
Arm Swing Velocity
时间窗: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average velocity of upper extremities in degrees per second as produced by the Mobility Lab software.
Stride Length
时间窗: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average stride length in m as produced by the Mobility Lab software.
Arm Range of Motion Asymmetry
时间窗: This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements.
The average difference between left and right arm range of motion in degrees as produced by the Mobility Lab software.
次要结局
未报告次要终点
研究者
Maja Kojović
assoc. prof.
University Medical Centre Ljubljana