Effects of Vagus Nerve Stimulation on Motor Performance After Stroke
Effect of Trans-auricular Vagus Nerve Stimulation on Plasticity Biomarkers,Interleukin-6 and Motor Performance Post Stroke : A Randomized Controlled Clinical Trial
This study is testing if a new type of nerve stimulation can help improve movement and brain recovery in people who had a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 55 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza, Dokki) |
| Trial ID | NCT06388954 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of transcutaneous auricular vagus nerve stimulation (taVNS) on motor performance and neuroplasticity in patients who have suffered an ischemic stroke. Seventy-eight patients aged 55 to 65 years, with stroke occurring 6 months to 2 years prior, will be randomly assigned to either a control group receiving sham stimulation or an experimental group receiving real taVNS, followed by physical therapy. The study will measure changes in plasma levels of Brain-Derived Neurotrophic Factors (BDNF) and Interleukin-6 (IL-6), as well as motor function through the Box and Blocks Test and Modified Ashworth Scale. Assessments will be conducted at baseline and immediately post-treatment to evaluate efficacy.
Who should consider this trial
Good fit: Ideal candidates are hemiparetic patients aged 55 to 65 years with ischemic middle cerebral artery stroke, experiencing upper limb motor function impairment for 6 months to 2 years.
Not a fit: Patients with other neurological diseases, hemorrhagic stroke, or significant cognitive and physical impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance motor recovery and neuroplasticity in stroke patients, leading to improved rehabilitation outcomes.
How similar studies have performed: Previous studies have shown promising results with vagus nerve stimulation in enhancing motor function and neuroplasticity, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 .
Where this trial is running
Giza, Dokki
- Faculty of Physical Therapy, Cairo University — Giza, Dokki, Egypt (Recruiting)
Study contacts
- Principal investigator: Engy B Saleh, PhD — Faculty of Physical Therapy, Cairo University, Egypt
- Study coordinator: Engy B Saleh, PhD
- Email: engybm.saleh@yahoo.com
- Phone: 00201099445112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.