Efficacy and safety of Transcutaneous Electrical Stimulation of Vagus Nerve in Upper Limb Motor Recovery Among Stroke survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Demographics, time since stroke, medication and vascular risk factors will be obtained from participants. Hospital records and imaging results will be viewed to record the size, location and precise date of the stroke.
研究概览
简要总结
Stroke is a neurological condition caused by vascular problems such as cerebral infarction and/or intra cerebral or subarachnoid hemorrhage1. Motor impairment occurs in 85% of patients with stroke, and it is considered one of the main problems resulting from this condition.
Efforts have been made to develop therapies that can improve motor impairment in stroke patients 8 Among these therapies are: constraint-induced movement 9, mirror therapy 10 and resistance training 11, however, these interventions have a low level of adherence 12 and the evidence supporting their effects is still weak 9-11
Recently, Vagus Nerve Stimulation (VNS) has been proposed as an intervention that could have beneficial effects in the recovery of motor function in these patients, since it contributes to the generation of adaptive neuroplasticity and the activation of neuromodulators that reduce brain inflammation 13, 14
Objective of our study to study the efficacy and safety of Transcutaneous Electrical Stimulation of Vagus Nerve in Upper Limb Motor Recovery among Stroke survivors.
We are going to do prospective randomized study on stroke patients having upper limb motor impairment.
The subject will comprise of clinically diagnosed stroke patients in OPD and IPD at AIIMS Bibinagar, Hospital, fulfilling the inclusion criteria of the study. In this study we are going to enroll patients by stratified randomization in two groups 30 in each group.
The Group A will get Vagus nerve stimulation using TENS with the clip electrodes placed at the Cymba conchae at the left ear (0.3ms pulses, 30Hz, intensity = maximum tolerable level) for 30 minutes, once a day, six days per week for 3 weeks with continuous monitoring of vital parameter in presence of a senior physiotherapist and emergency medical care and also underwent rehabilitation therapy only (3-week course of 2-h therapy sessions, 3x week, at least 300 to 400 movements per session).
Group B will get sham stimulation with the clip electrodes placed at Cymba conchae at the left ear for 30 minutes, once a day, six days per week for 3 weeks followed by rehabilitation therapy only (3-week course of 2-h therapy sessions, 3x week, at least 300 to 400 movements per session).
Outcome will be measured after 3 weeks of treatment by Upper Limb Fugl-Meyer (UFM) and Action Recovery Arm Test. To observe long-term effects, evaluation will be done at 6 weeks and 12 weeks after first intervention.
The main safety outcome measure will be the number of serious adverse events related to the device or therapy, such as skin toxicity (pain, skin erythema, burns, etc.), hoarseness, and dysphasia. Heart rate (HR) and blood pressure (BP) will also observe before and after each intervention.
Outcome Assessor will be blinded to study group allocation.
We are going to compare the results of these two groups to see efficacy and safety of vagus nerve stimulation in stroke patients of upper limb motor recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: 18 years and above.
- •2.Patients having an ischemic stroke for at least 3 months previously 3.No strict cut-offs will be required for baseline upper limb function as long as the 4.Participant could engage with the therapist and perform the limb movements.
排除标准
- •1.Patients having impairments of upper limb function other than those caused by stroke 2.Hemorrhagic Stroke 3.Patients having aphasia or cognitive difficulties severe enough to interfere with the informed consent process, task specific practice or communication of adverse events, 4.Pregnant or trying to get pregnant patients 5.Patients having a pacemaker or other implanted electrical device 6.Patients having severe spasticity (a Modified Ashworth Score12 ≥3).
- •7.Low hearth rate (<60 bpm); 8.Apraxia 9.Excessive pain in any joint of the paretic extremity 10.Advanced liver, kidney, cardiac, or pulmonary disease 11.History of significant alcohol or drug abuse 12.Depression or use of neuropsychotropic drugs such as antidepressants or benzodiazepines.
结局指标
主要结局
Demographics, time since stroke, medication and vascular risk factors will be obtained from participants. Hospital records and imaging results will be viewed to record the size, location and precise date of the stroke.
时间窗: These assessments will be performed at baseline and at the end of the intervention (3 | weeks). To observe long-term effects, evaluation will be done at 6 weeks and 12 weeks after | first intervention.
Two measures of upper limb movement and functional independence will be assessed:
时间窗: These assessments will be performed at baseline and at the end of the intervention (3 | weeks). To observe long-term effects, evaluation will be done at 6 weeks and 12 weeks after | first intervention.
1. Upper Limb Fugl-Meyer (UFM)
时间窗: These assessments will be performed at baseline and at the end of the intervention (3 | weeks). To observe long-term effects, evaluation will be done at 6 weeks and 12 weeks after | first intervention.
2. Action Recovery Arm Test (ARAT).
时间窗: These assessments will be performed at baseline and at the end of the intervention (3 | weeks). To observe long-term effects, evaluation will be done at 6 weeks and 12 weeks after | first intervention.
次要结局
- NA(NA)