Effect of Trans-auricular Vagus Nerve Stimulation on Plasticity Biomarkers,Interleukin-6 and Motor Performance Post Stroke : A Randomized Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Faculty of Physical Therapy, Cairo University
RECRUITING
Giza
Contact Information
Primary
Engy B Saleh, PhD
engybm.saleh@yahoo.com
00201099445112
Backup
Moshera H. Darwish, PhD
dr.moshera11@yahoo.com
00201015163617
Time Frame
Start Date: 2024-05-28
Estimated Completion Date: 2025-05-18
Participants
Target number of participants: 80
Treatments
Placebo_comparator: Control group (GA)
Patients in the control group (GA) will be treated by 12 sessions of sham transcutaneous auricular Vagus nerve stimulation for 30 minutes immediately, will be followed by 30 minutes of a selected physical therapy program, three sessions per week for four consecutive weeks. Sham transcutaneous vagal nerve stimulation was performed using the same procedures as the study group but without electrical stimulation.
Experimental: Study group (GB)
Patients in the study group (GB) will be treated by 12 sessions of true transcutaneous auricular Vagus nerve stimulation for 30 minutes , then immediately followed by 30 minutes of a selected physical therapy program (GA), three sessions per week for four consecutive weeks. The stimulation of the auricular branch of the Vagus nerve will be performed by conventional TENS device with one channel and two electrodes.
Related Therapeutic Areas
Sponsors
Leads: Cairo University

This content was sourced from clinicaltrials.gov