Effect of Trans-auricular Vagus Nerve Stimulation on Plasticity Biomarkers,Interleukin-6 and Motor Performance Post Stroke : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Muscle tone of the upper limb
研究概览
简要总结
Seventy-eight clinically verified Egyptian patients from both sexes with ischemic stroke that occurred at least 6 months to 2 years before inclusion will be randomly assigned into 2 groups, control group (GA) and the experimental group (GB). Patients will be randomly assigned into two equal groups: the control group (GA) and the experimental group (GB). Patients in the control group (GA) will be treated with sham Vagus nerve stimulation (taVNS) immediately before a selected physical therapy program, while in the experimental group (GB), patients will receive real transcutaneous auricular Vagus nerve stimulation (taVNS) followed by the same selected physical therapy program as (GA). Plasma level of Brain-Derived Neurotrophic Factors (BDNF) and Interleukin-6 (IL-6), Box and Blocks Test (BBT), and modified Ashworth scale (MAS) will be assessed at baseline and immediately post-treatment.
详细描述
Background: Neuromodulation techniques play an integral role in restoring motor function in stroke patients by affecting the adaptive neuroplasticity and activation of neuromodulators that may reduce brain inflammation post stroke.
Objective
To assess the efficacy of transcutaneous auricular vagal nerve stimulation on plasma levels of Brain-Derived Neurotrophic Factors (BDNF), Interleukin-6 (IL-6), gross manual dexterity, and muscle tone in patients with ischemic stroke.
Materials and Methods
Seventy-eight clinically verified Egyptian patients from both sexes with ischemic stroke that occurred at least 6 months to 2 years before inclusion, aged 55 to 65 years, were recruited. Patients will be randomly assigned into two equal groups; control group (GA) and the experimental group (GB). Patients in the control group (GA) were treated with sham Vagus nerve stimulation (taVNS) immediately before a selected physical therapy program, while in the experimental group (GB), patients received real transcutaneous auricular Vagus nerve stimulation (taVNS) followed by the same selected physical therapy program as (GA). Plasma levels of Brain-Derived Neurotrophic Factors (BDNF), serum Interleukin-6 (IL-6) , Box and Blocks Test (BBT) and Modified Ashworth scale (MAS) were assessed at baseline and immediately post-treatment.
Results: There was a statistically significant improvement in BBT, plasma IL-18 level and BDNF in experimental group (GB) post-treatment (P< 0.05) with no change in MAS. There was no statistical significant difference in BBT, plasma Interleukin-6 (IL-6) and MAS in control group post treatment (P> 0.05). While, there is a statistically significant improvement in BDNF in the control group post treatment. A statistically significant improvement was observed of BBT and BDNF in the study group compared to the control group (P< 0.05). There was no statistical significant difference in MAS between study and control groups (P> 0.05).
Conclusions: Non-invasive VNS as an adjunct to conventional physical rehabilitation enhances neuroplasticity and improves upper limb motor ability after ischemic stroke, as well as reducing the stroke-induced inflammatory process, which may affect the disease prognosis.
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
- Single (Participant)
盲法说明
Patients participated will be masked about the type of intervention, where (GA) patients will receive physical therapy program + sham transcutaneous auricular Vagus nerve stimulation, while patients in (GB) will receive true transcutaneous auricular Vagus nerve stimulation in addition to the same physical therapy program as (GA).
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemiparetic patients with ischemic middle cerebral artery stroke
- •The duration of illness ranged from at least 6 months to 2 years after stroke.
- •Patient's age ranged from 55 to 65 years, patients with unilateral upper limb motor function impairment.
- •Patients able to transfer at least one block in Box and Blocks Test.
- •Patients with sufficient cognitive abilities that enables them to understand and follow instructions.
- •Spasticity of upper limb muscles ranged from (grade 1:2) according to Modified Ashworth scale.
排除标准
- •Other neurological diseases that affect upper limb function other than stroke (e.g.: Multiple sclerosis, peripheral neuropathy, Parkinsonism....etc.).
- •Hemorrhagic stroke
- •Visual or auditory impairment affecting their ability to complete the testing.
- •Cognitive impairment.
- •Cardiovascular problems and pulmonary or kidney disorders
- •Musculoskeletal disorders (e.g. scoliosis, kyphosis, severe arthritis...etc.)
- •Severe spasticity (a Modified Ashworth Scale score ≥3).
- •Patients with any taVNS contraindications such as previous surgical intervention on Vagus nerve.
- •Low blood pressure (<100/60mmHg) or low heart rate (<60bpm) and or high blood pressure (>220/130 mmHg).
- •Pacemaker or other implanted electrical device.
- •Any current or past history of cardiovascular disorders
- •Facial or ear pain
- •Recent ear trauma .
结局指标
主要结局
Muscle tone of the upper limb
时间窗: Baseline Assessment and Immediately Post Treatment.
The Modified Ashworth Scale (MAS) will be used; it is a six-point ordinal scale. It ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The muscle tone was measured by observing the response of the muscle group to the resistance of passive movement in the affected hand. The degree of muscle tone in the affected hand was classified as (0 = normal, 1 or 1+ = mild, 2 or 3 = moderate, or 4 = severe).
Level of Plasma brain-derived Derived factor (BDNF)
时间窗: Baseline Assessment and Immediately Post Treatment.
Sandwich-ELISA kits will be used according to the manufacturer's instructions. Venous blood samples were collected in a disposable plastic vacuum tube with an anticoagulant. Samples were centrifuged for 15 min at 1000×g at 2-8 °C within 30 min of collection.
Gross hand dexterity
时间窗: Baseline Assessment and Immediately Post Treatment.
The Box and Blocks Test (BBT) will be used; it is a quick, simple, and inexpensive test for measuring unilateral gross manual dexterity in stroke. The patients were asked to transfer as many blocks as they could from one compartment to the other for 60 seconds. The patient was allowed to choose any block of any color and to carry only one block each time with his hand, which must cross over the partition.
Level of Serum Interleukin IL-6
时间窗: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Interleukin-6 (IL-6) is a crucial inflammatory factor in that its significant increase was observed in stroke patients shortly following the ischemic event and serves a vital role as a messenger molecule between leucocytes, the vascular endothelium, and parenchyma. A single referral lab will test the samples using ELISA and U/CyTech kits. From each participant, 10 milliliters of non-fasting blood sample will be obtained 6 to 24 hours after the onset of symptoms and kept in citrate tubes. Blood samples will thereafter centrifuged within 1 hour at 3000 × g for 15 minutes at 4°C and resultant plasma will be kept in -80°C.
次要结局
未报告次要终点
研究者
Engy Badreldin Saleh Moustafa, PhD
Principal Investigator
Cairo University