NCT06388954 Plasticity Biomarkers,Interleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke
| NCT ID | NCT06388954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-05-28 |
| Primary Completion | 2025-01-25 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 spasticit
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