An interventional study of Transcutaneous auricular vagus nerve stimulation and selected physical therapy program in Stroke, Ischemic, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Cairo University · Not applicable, Interventional, and Prevention
The goal of this interventional study is to investigate the therapeutic efficacy of non-invasive vagus nerve stimulation on upper limb function in chronic stroke patients . The main question is:
•Is there a significant effect of non-invasive vagal nerve stimulation on upper limb motor function in stroke patients? Participants will be assigned into two groups. They will receive 12 sessions of true or sham transcutaneous auricular vagus nerve stimulation for 30 minutes immediately followed by 30 minutes of selected physical therapy program, three sessions per week for four weeks.
Stroke causes several neurological deficits or impairments as hemiparesis, communication disorders, cognitive deficits or disorders in visuo-spatial perception. Approximately 60% of survivors after stroke suffer from upper limb motor impairment, which lead to loss of independence with poor quality of life. These global economic and social costs of chronic disability due to stroke necessitate the development of new methods beside the conventional treatment to induce neuroplasticity in stroke recovery.Vagus nerve stimulation (VNS) is a neuromodulation therapy, which sends impulses into the neural center to generate corresponding nervous activity. Vagus nerve stimulation is an established treatment in epilepsy, depression, chronic tinnitus, migraine and chronic pain.Vagus nerve stimulation can be invasive or non-invasive. Invasive VNS requires the implantation of a programmable device and electrodes that directly stimulate afferents of the vagus nerve under general anesthesia. Non-invasive method of VNS via transcutaneous stimulation of the peripheral auricular branch of the vagus nerve (taVNS) is safer, better-tolerated method for delivering VNS with the same effect of invasive VNS.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Twenty Egyptian stroke patients from both sex will receive 30 minutes of transcutaneous vagal nerve stimulation at cymba concha of left ear immediately after a 30 minutes session of selected physical therapy program.
Other: Transcutaneous auricular vagus nerve stimulation · Other: selected physical therapy program
Twenty Egyptian stroke patients from both sex will receive 30 minutes of sham vagal nerve stimulation at ear lobe of left ear immediately after a 30 minutes session of selected physical therapy program.
Other: selected physical therapy program
Patients in this group will be treated with 12 sessions of transcutaneous auricular nerve stimulation, three sessions per week for four weeks. The stimulation of the left auricular branch of the vagus nerve will be performed by conventional transcutaneous electrical nerve stimulation (TENS) through a Gamna Duo 200 electrotherapy device with one channel and two electrodes (5mm diameter disposable adhesive stimulation electrodes). The TENS parameters will be used: 30 30-minute treatment time, a pulse width of 200 milliseconds, and a pulse frequency of 20 hertz. The intensity of stimulation will be individually adjusted according to the patient's perceptual threshold. The perceptual threshold (PT) is defined as the minimum amount of electricity required to perceive electrical stimulation on the skin described as a pricking or tingling sensation. The stimulation intensity will be set at super-threshold levels, such as 200% of the patient's perceptual threshold.
The selected physical therapy program session will be from 25 to 30 minutes, three sessions per week for four weeks. The program will be selected mainly for stretching for shortened upper limb muscles, strengthening for weak upper limb muscles, occupational therapy for hand, trunk, and pelvic control exercises, and gait training.
Changes in upper limb function from baseline to four weeks after the beginning of intervention
Fugl-Meyer Assessment for upper extremity (FMT-UE).
Time frame: four weeks after the beginning of the intervention
Changes in serum levels of neural plasticity factors from baseline to four weeks after beginning of intervention
serum levels of Brain Derived Neurotrophic Factor (BDNF)
Time frame: four weeks after the beginning of the intervention
Changes in peak muscle torque of upper limb muscles from baseline to four weeks after the beginning of intervention
Peak muscle torque measured by Biodex System 3 Pro Isokinetic (Biodex Medical Inc., Shirley, New York, USA).
Time frame: four weeks after the beginning of the intervention
Changes in hand grip strength from baseline to four weeks after the beginning of intervention
Hand grip strength measured by electronic BASELINE hand dynamometer device.
Time frame: four weeks after the beginning of the intervention
Changes in gross hand function from baseline to four weeks after the beginning of intervention
Box and Blocks Test (BBT)
Time frame: four weeks after the beginning of the intervention
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Cairo University