Plasticity Biomarkers,Interleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke

Launched by CAIRO UNIVERSITY · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how a specific treatment called Vagus nerve stimulation affects patients who have had a stroke. The researchers want to see if this treatment can help improve movement and brain function in patients who have experienced an ischemic stroke (a type of stroke caused by a blocked blood vessel) at least 6 months to 2 years ago. The study will involve 48 participants, aged between 55 and 65, who have some difficulty moving one arm. They will be divided into two groups: one group will receive the actual treatment, while the other will receive a fake version of the treatment (to compare results). Both groups will also go through a physical therapy program.

To be eligible for the trial, participants should be able to perform some basic movements with their affected arm and have enough understanding to follow instructions. Participants will undergo tests to assess their motor skills and levels of certain brain and immune system markers before and after the treatment. This trial is currently looking for volunteers, and it is important to note that individuals with other serious health conditions, such as neurological disorders or heart issues, would not qualify for this study. If you or someone you know is interested in participating, this trial may offer insights into new ways to enhance recovery after a stroke.

Gender

ALL

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 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 .