NCT05779293

Effect of Vagus Nerve Stimulation on Chronic Stroke Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Istanbul Medipol University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Stroke is still one of the top causes of death and adult-onset disability in the world. Despite physiotherapy and rehabilitation, a sizable percentage of chronic stroke patients are permanently disabled. These neurological deficiencies include cognitive impairment, sensory impairment, loss of coordination, spasticity, dysphasia, dysphagia, visual field dysfunction, and weakness.

Detailed description

Exercises, neurophysiological and electrical stimulations, compensatory strategies, strengthening facilitation approaches programs, and programs are all used as general approach methods in the rehabilitation of stroke patients. Transcutaneous stimulation of the vagus nerve offers non-invasive stimulation of the vagus nerve and is commonly carried out by stimulating the auricular vagus nerve in the ear or transcutaneous cervical branch vagus in the neck.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Non-invasive auricular vagus nerve stimulation	The only cutaneous nerve of the N. vagus, ramus auricularis, receives sensation from the posterior surface of the auricle, the posterior part of the external auditory canal and the adjacent part of the eardrum. Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. This device non-invasively stimulates the auricular branch of the vagus nerve without any action. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased. The application will take 30 minutes three days a week for four weeks.
OTHER	Conventional therapy	Conventional approaches are approaches that cover range of motion, strength, balance and ambulation training, continuing from passive to resistant exercises. Neuromuscular electrical stimulation; It is applied to reduce pain, prevent spasticity and strengthen muscles. This newly formed type I fiber functionally shows an increase in resistance to fatigue and a decrease in maximum contraction velocity. The application will take 30 minutes three days a week for four weeks.

Timeline

• Start date: 2023-03-09
• Primary completion: 2023-06-05
• Completion: 2023-10-05
• First posted: 2023-03-22
• Last updated: 2023-03-27

Locations

1 site across 1 country: Turkey (Türkiye)