RecruitingNot ApplicableNCT06388954

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

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

Sponsor

Cairo University

Enrollment

80 participants

Start Date

May 28, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke Motor Disorders

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

Min Age: 55 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria13

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 .

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Interventions

DEVICETrue Transcutaneous auricular Vagus Nerve Stimulation (TaVNS)

Vagus Nerve Stimulation (VNS) consists in the activation of the Vagus nerve using electrical current, Transcutaneous auricular VNS works through the placement of noninvasive electrodes on the neck or auricle for stimulation of the auricular branch of the vagus nerve. Transcutaneous electrical nerve stimulation (TENS) electrodes will be used to stimulate the auricular branch of the Vagus nerve, The active electrode will be placed on the cymba concha of the left ear. This reduced the risk of taVNS side eﬀect on the heart. The reference electrode will be placed outside the left ear attached to the tragus. TENS parameters used were: 30 minutes treatment time, a pulse width of 300 microseconds, pulse frequency 20 hertz and a duty cycle of 25%. The stimulation intensity was set at super-threshold levels, such as 200% of patient perceptual threshold.

DEVICESham Trancutaneous auricular Vagus Nerve Stimulation

Sham transcutaneous vagal nerve stimulation will be performed by the same procedures of the study group but without electrical stimulation. The active electrodes will be attached to the left cymba conchae. The taVNS stimulator will be turned on and the stimulation intensity will be increased until the patient perceived the electrical stimulation and then the stimulator will be turned off.