Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388954
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-19
Brief Title:
Plasticity BiomarkersInterleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Neural-Plasticity Biomarkers Interleukin-6 and Motor Performance in Response to Non-Invasive Vagus Nerve Stimulation After Stroke A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Forty-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
Detailed Description:
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 Forty-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 005 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 005 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 005 There was no statistical significant difference in MAS between study and control groups P 005
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
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 Forty-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 005 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 005 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 005 There was no statistical significant difference in MAS between study and control groups P 005
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None