Effect of Vagus Nerve Stimulation on Chronic Stroke Patients

NCT ID: NCT05779293

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2023-10-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

non-invasive auricular vagus nerve stimulation

non-invasive auricular vagus nerve stimulation + Neuromuscular Electrical Stimulation (NMES) exercise under the supervision of a physiotherapist

Group Type: EXPERIMENTAL

Non-invasive auricular vagus nerve stimulation

Intervention Type: DEVICE

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.

Conventional physical therapy

NMES exercise under the supervision of a physiotherapist

Group Type: ACTIVE_COMPARATOR

Conventional therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• To be between the ages of 18-80.
• Having been diagnosed with a stroke by a neurologist.
• Speech disorder after a cerebrovascular accident to be.
• To volunteer to participate in the study.

Exclusion Criteria

• Being mentally affected (Mini-Mental Test Score <24).
• Having other neurological diseases other than stroke.
• Concomitant symptoms that prevent individuals from participating in the study (Having undergone amputation surgery, having cardiac arrhythmias be etc.)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hazal genc

physiotherapist PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medipol hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

HAZAL genç, PhD

Role: CONTACT

hazaloksuz@gmail.com

05413204291

gamze demircioğlu, PhD

Role: CONTACT

Facility Contacts

HAZAL genç, phd

Role: primary

References

Baig SS, Kamarova M, Ali A, Su L, Dawson J, Redgrave JN, Majid A. Transcutaneous vagus nerve stimulation (tVNS) in stroke: the evidence, challenges and future directions. Auton Neurosci. 2022 Jan;237:102909. doi: 10.1016/j.autneu.2021.102909. Epub 2021 Nov 14.

Reference Type: BACKGROUND

PMID: 34861612 (View on PubMed)

Other Identifiers

Stroke

Identifier Type: -

Identifier Source: org_study_id