Effect of Vagus Nerve Stimulation on Chronic Stroke Patients

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: Non-invasive auricular vagus nerve stimulation; Other: Conventional therapy

• Registration Number: NCT05779293
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-09
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-22
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-27
• Primary Completion: 2023-06-05
• Study Completion: 2023-10-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-invasive auricular vagus nerve stimulation	Non-invasive auricular vagus nerve stimulation	non-invasive auricular vagus nerve stimulation + Neuromuscular Electrical Stimulation (NMES) exercise under the supervision of a physiotherapist
Conventional physical therapy	Conventional therapy	NMES exercise under the supervision of a physiotherapist

Primary Outcome Measures

Name	Time	Method
Timed Get Up and Go Test	4 weeks	Getting out of the chair is in the form of walking back and forth 3 meters and sitting on the chair again. The aim is to measure the individual's time to complete this process. A high score indicates a high disability score.
The Modified Ashworth Scale,	4 weeks	The Modified Ashworth Scale, developed by Ashworth, is an international method used to evaluate the resistance encountered during passive muscle stretching in muscles with spasticity, which were later modified. It is rated at 6 levels from 0 to 4 to assess muscle tone. The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extensio
Standardized Mini Mental State Test	4 weeks	The Mini Mental Test is a test that can be applied in outpatient clinic conditions or at the bedside in a period of 10 minutes by physicians, nurses and psychologists who have received a short training.; It consists of eleven items gathered under five main headings as orientation, recording memory, attention and calculation, recall and language, and is evaluated out of a total score of 30.Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Brunstrom Hemiplegia Recovery Stages	4 weeks	Brunnstrom Score; It was used to evaluate motor recovery in the upper extremity, hand, and lower extremity, as well as to indicate which motor level the patient was at. Brunnstrom is a 6-digit scale containing progressively improving movement patterns for each area used
Berg Balance Scale	4 weeks	Berg Balance Scale is a scale developed to measure balance performance in geriatric people or geriatric patients. It is frequently used in clinical studies to evaluate postural control and to predict fall risk.scoring is between 0-51 points, with a high score indicating good balance.
Montreal Cognitive Assessment Scale	4 weeks	It was developed as a rapid screening test for mild cognitive impairment. These are; attention and concentration, executive functions, memory, language, visual construction skills, abstract thinking, calculation and orientation. Montreal Cognitive Assessment Scale scores range between 0 and 30. It is between 0-30 points. A score of 21 and above is considered normal.A high score indicates a good cognitive level.

Secondary Outcome Measures

Name	Time	Method
Stroop test	4 weeks	The Stroop Test is a neuropsychological test that reflects frontal region activity. The Stroop Test, which measures information processing speed, automatic and parallel processing in cognitive processes, reflects the brain's frontal region activity, as well as its color-word-distorting effect and attention, is a measurement tool widely used in basic science studies as well as in application areas.

Trial Locations

Locations (1)

Medipol hospital; 🇹🇷 Istanbul, Turkey