Actively Recruiting
Plasticity Biomarkers,Interleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke
Led by Cairo University · Updated on 2025-05-13
80
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Plasticity Biomarkers,Interleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hemiparetic patients with ischemic middle cerebral artery stroke
- Stroke occurred at least 6 months and up to 2 years before inclusion
- Age between 55 and 65 years
- Unilateral upper limb motor impairment
- Able to transfer at least one block in the Box and Blocks Test
- Sufficient cognitive ability to understand and follow instructions
- Upper limb spasticity grade between 1 and 2 on Modified Ashworth Scale
You will not qualify if you...
- Other neurological diseases affecting upper limb function (e.g., multiple sclerosis, peripheral neuropathy, Parkinsonism)
- Hemorrhagic stroke
- Visual or auditory impairments affecting test completion
- Cognitive impairment
- Cardiovascular, pulmonary, or kidney disorders
- Musculoskeletal disorders such as scoliosis, kyphosis, or severe arthritis
- Severe spasticity (Modified Ashworth Scale score 3 or higher)
- Previous surgical intervention on the vagus nerve or taVNS contraindications
- Low blood pressure (<100/60 mmHg) or low heart rate (<60 bpm) or high blood pressure (>220/130 mmHg)
- Presence of pacemaker or other implanted electrical devices
- Current or past cardiovascular disorders
- Facial or ear pain
- Recent ear trauma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Faculty of Physical Therapy, Cairo University
Giza, Dokki, Egypt, 11432
Actively Recruiting
Research Team
E
Engy B Saleh, PhD
CONTACT
M
Moshera H. Darwish, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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