Non-invasive VNS in Stroke Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery
研究概览
简要总结
To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery
详细描述
In this study, (Aim 1) we will test whether our non-invasive trans-auricular vagus nerve stimulation (taVNS) during occupational therapy task performance has the potential for large scale application through superior clinical benefit compared to sham in a broad group of stroke survivors including hemorrhagic strokes.
To determine the predictors of effective brain rewiring in the individual stroke patient, we will use an EEG and/or functional MRI (fMRI) connectivity biomarker independently of the success of the stimulation paradigm (Aim 2). We will test the hypothesis that better motor function will be associated with increased motor network connectivity pattern.
The central objective of this application is to determine whether taVNS significantly improves motor recovery for both ischemic and hemorrhagic strokes through increased connectivity as measured by a biomarker of plasticity. We address our objective through the following aims:
Aim 1: To determine the extent to which taVNS with concurrent occupational therapy (OT), causes significant, lasting motor gains in chronic stroke population
Hypothesis A: More chronic stroke patients treated with taVNS+OT will show clinically meaningful improved hand motor function over Sham+OT immediately after treatment as measured by upper extremity Fugl-Meyer (uFM) test response rate. 60 patients at least 6 months after ischemic or hemorrhagic stroke with persistent arm weakness will be enrolled in a 6-week double masked, sham-controlled, balanced parallel group design phase 2 clinical trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging resulting in hemiparesis (MRC 1-4).
- •Age more than 18, Male or Female, All racial and ethnic groups
- •Entry into the study >6 months post onset
- •Patients who can safely undergo taVNS
- •Able to follow 2 step commands
- •Modified Ashworth Scale Score =<3 in the involved upper extremity
- •Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand
- •UFM =< 60 (scale 0-66)
排除标准
- •Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions).
- •Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
- •Subjects with contraindication to MRI of the brain
- •Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, epilepsy or others).
- •Patients with unstable cardiac arrhythmia, reentry tachycardia.
- •Pregnancy
- •Patients with pacemakers or stimulators that interfere with the stimulation, or other investigational devices or drugs
- •Non-English speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. However we plan to include them once funding has been secured in the subsequent larger trial.
研究组 & 干预措施
Sham Stimulation
Same procedure as with the active stimulation using the device's sham settings to elicit the same cutaneous sensation as the other stimulation conditions..
干预措施: taVNS (Device)
taVNS
Weak current (up to 0.8-4 mA) will be delivered using pulses according to standard protocol during each motor task for up to 90-minutes through surface electrodes which will be administered using the intensity identified as resulting in well tolerated skin sensation and best motor performance during our initial testing session.
干预措施: taVNS (Device)
结局指标
主要结局
To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery
时间窗: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]
To determine the extent to which taVNS with concurrent occupational therapy (OT), causes significant, lasting motor gains in chronic stroke population Upper extremity Fugl-Meyer (uFM) The uFM test measures both proximal and distal upper extremity movements, ranges 0-66, higher score is better.
次要结局
- To evaluate the biomarkers of plasticity associated with VNS([Time Frame: Baseline 1(week 1), post-intervention (week 6), post intervention for sham crossover only (week 12)])
- Wolf Motor Function Test (WMFT)([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)])
- Functional upper extremity levels (FUEL)([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)])
- NIH STROKE SCALE (NIHSS)([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Max score 42, minimum score 0. Score of 0 is best outcome)
- MRC grading scale([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, max score 5 per item. 5 is normal, 0 is no movement.)
- Timed up and Go([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)])
- Barthel Index (BI)([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, maximum score 100. Higher score is better)
- Stroke Impact Scale (SIS)([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, maximum score 100. 0 means no recovery, 100 means fully recovered)
- Zarit Burden Interview: Short (12-items)([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)])
- Modified Rankin Scale (mRS)([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)])
- Modified Ashworth Spasticity Scale([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)])
- Quick Inventory of Depressive Symptomatology, Self-report (QIDS-SR)([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, maximum score greater than 21. 0-5 means normal, greater than 21 is not)
- taVNS questionnaire([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)])
- Motor Activity log([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)])
- Wrist flexion-extension measurement([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)])
- To determine the taVNS induced connectivity pattern of the brain([Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)])
研究者
Timea Hodics
Director, Interventional Neuro-Recovery Program
The Methodist Hospital Research Institute