Ischemic stroke
Conditions
Interventions
VNS + Rehab Group:7 seconds of VNS with amplitude of 0.8mA, pulse width of 130µs, frequency of 30Hz and interval time of 3 minutes during rehabilitation.
Rehab Only Group:Standard rehabilitation.
Sponsors
Huashan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. History of unilateral supratentorial ischemic stroke that occurred = 6 months but = 24 months prior to enrollment. 2. Age = 40 years and = 70 years. 3. Unilateral limb weakness, FMA-UE score = 30 and = 80. 4. Ability to communicate, understand, and give appropriate consent. 5. Understand and sign the informed consent before treatment, and be excluded from surgical contraindication.
Exclusion criteria
Exclusion criteria: 1. History of hemorrhagic stroke. 2. Presence of ongoing dysphagia or aspiration difficulties. 3. Subjects receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems (e.g. stimulants, vasoactive drugs, cardiac agents etc.) at study entry. 4. Prior injury to vagus nerve, either bilateral or unilateral. 5. Severe or worse depression (Beck Depression Scale > 29). 6. Unfavorable candidacy for device implant surgery. 7. Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug. 8. Pregnancy or plans to become pregnant or to breastfeed during the study period. 9. Current requirement, or likely future requirement, of diathermy during the study duration. 10. Active rehabilitation within 4 weeks prior to consent. 11. Botox injections or any other non-study active rehabilitation of the upper extremity within 4 weeks prior to therapy through the post-90 day visit. 12. Severe spasticity of the upper limb (Modified Ashworth =3). 13. Significant sensory loss. Sensory loss will be measured using the Upper Extremity sensory section of the Fugl Meyer Assessment of Physical Performance. The assessment addresses light touch (2 items) and proprioception (4 items). Subjects with scores less than 6 will be excluded from the study. 14. Subjects with severe medical disease, e.g., ALT > 2 times the upper limit of the normal range, Cr > 6 times the upper limit of the normal range, severe pulmonary insufficiency or arrhythmias, etc. 15. Subjects with other intracranial diseases, e.g., intracranial infection, high-grade malignant tumor, primary epilepsy, etc. 16. Subjects with other neurological diseases, e.g., Parkinsons disease, Alzhiemer’s disease, peripheral neuropathy, etc. 17. Subjects with psychiatric disorders, e.g., schizophrenia, major depressive disorder, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer rating scale for upper extremity (FMA-UE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Other clinical scales: Functional independence measure, Berg balance scale, Action Research arm test;Evaluation for motor and balance function: Gait analysis, Surface electromyography, Surface electromyography;TMS assessment: Motor threshold, Central motor conduction time, Interhemispheric inhibition;Functional near-infrared spectroscopy;CT perfusion;Electroencephalography;Positron emission tomography–computed tomography; | — |
Countries
China
Contacts
Public ContactLiang Chen
Huashan Hospital affiliated to Fudan University
Outcome results
None listed