Effects Of Transcutaneous Vagus Nerve Stimulation With Virtual Reality In Post-Stroke Patients

Effects of Transcutaneous Vagus Nerve Stimulation With Virtual Reality on Upper Limb Functions in Post-stroke Patients

Stroke is a neurological condition also known as cerebrovascular accident occurs when blood supply to the brain is disrupted ,either by blockage or rupture of a blood vessels. Upper limb impairment after a stroke denotes diminished function in the arm, hand, wrist, and fingers due to neurological damage. Virtual Reality and Trascutaneous vagus nerve stimulation are innovative for post-stroke upper limb rehabilitation VR enhances motor learning and engagement with exercises and feedback, while VNS boosts neuroplasticity and reduces inflammation via vagus nerve stimulation. The aim of the study is to determine the effects of transcutaneous vagus nerve stimulation with virtual reality and routine physiotherapy on upper limb motor function, hand dexterity function and quailty of life .

This randomized clinical trial will be conducted at Al Ehsan Welfare,Lahore .The sample size calculated for this trial will be 50 .The patients will be randomly allocated using online randomization tool into 2 groups. Group A will receive Transcutaneous vagus nerve stimulation with Virtual Reality and Routine physical therapy.Patients will undergo a 60-minute session for four weeks, consisting of 30 minutes of vagus nerve stimulation, 15 minutes of virtual reality training, and 15 minutes of routine physiotherapy for 4 weeks, Group B will receive Transcutaneous Vagus Nerve Stimulation with Routine physical therapy Patients will undergo a 60-minute session for four weeks, which includes 30 minutes of vagus nerve stimulation and 30 minutes of routine physiotherapy per session for 4 weeks.

Purdue pegboard test will be used to assess dexterity function,Fugl - meyer assesment FMA - UE to assess Motor function of upper extremity, Stroke impact scale to measure Quality of life.The assessment will be conducted by assessor at baseline, 2 weeks, 4 weeks, and during a follow-up at 8 weeks after discontinuation of in-clinic therapy.The p value will be set at P= 0.05 to reported any significant difference.Kolmogorov-smirnov test will be used to check the normality of data . For the between group analysis Independent t test will be applied for parametric and Mann Whitney test will be applied for non parametric data. For within group comparison repeated measure ANOVA and Friedman ANOVA will be applied for parametric and non parametric data

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy; Other: transcutaneous vagus nerve stimulation+routine physical therapy

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Kashif, PhD-PT; Phone Number: +923333125303; Email: kashif.shaffi@gmail.com
• Study Contact Backup: Name: Adeela Ayub, DPT; Phone Number: 03314196940; Email: adeelamalik0914@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with ischemic stroke at least more than 6 months.
• Patients having Montreal Cognitive Assessment (MoCA) score 26/30
• Patients able to follow and accept verbal instruction
• patients with normal sympathetic acitivity.

Exclusion criteria:

• Patients with history of previous surgical intervention on vagus nerve
• Patients having low heart rate 60 bpm
• Patients with history of any visual and hearing problem
• Patients with history of neuromuscular disorder affecting the function of upper limbs .
• Patients with advance liver,kidney,cardiac ,pulmonary disease
• Patients with history of orthopedic surgery and botulinum toxin injection.
• Patients with increase sympathetic activity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Transcutaneous vagus nerve stimulation+Virtual Reality+Routine physical therapy; Patients will undergo a 60-minute session for two weeks, consisting of 30 minutes of vagus nerve stimulation, 15 minutes of virtual reality training, and 15 minutes of routine physiotherapy for 4 weeks	Other: transcutaneous vagus nerve stimulation+virtual reality+routine physical therapy; Transcutaneous vagus nerve stimulation Location The left auricular branch vagus nerve will be stimulated by the modified dot -like electrodes will be fitted to the cymba conchae.frequency:Stimulation perform for 30 minutes per day for 4 weeks . duration 600 pulses (intratrain pulse) frequency =20 Hz ; Pulse duration =0.3ms ,lasting 30 seconds each time ,stimulating once every 5 minutes
Experimental: Group B: Transcutaneous Vagus Nerve Stimulation +Routine physical therapy; Patients will undergo a 60-minute session for two weeks, which includes 30 minutes of vagus nerve stimulation and 30 minutes of routine physiotherapy per session for 4 weeks.	Other: transcutaneous vagus nerve stimulation+routine physical therapy; Transcutaneous vagus nerve stimulation Location The left auricular branch vagus nerve will be stimulated by the modified dot -like electrodes will be fitted to the cymba conchae.Stimulation perform for 30 minutes per day for 4 weeks . Routine physical therapy Stretching Areas :upper chest ,neck flexors ,shoulder flexor and adductors ,elbow and wrist flexors 10 minute per session,and stretches will held for 10s -30swith four repetition of each.30 minutes per day for 4 weeks Upper extremity Proprioception ,coordination,speed and agility increase such as followReach and grasp Handle turning simulated eating task Inserting object Opening bottle strenghtening exercise Muscles biceps brachii brachialis Coracobrachialis triceps brachii wrist extensors 10 minute per session for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment (FMA)	The Fugl-Meyer Assessment is a well established and effective clinical tool designed to assess motor function in individual extensively validated in stroke patients.	4th week
Purdue pegboard test	Purdue pegboard test The Purdue Pegboard Test developed by Joseph Tiffin in 1948 ,is widely utilized by clinicians and researchers to assess both gross movementand fingertip dexterity of the arm,hand,and fingers. It consist of a board with 4 cups across the top,containing pegs ,collars,and washers, and two vertical rows of 25 small holes down the center .This test is particularly suitable for evaluating patients with upper extremity impairments caused by neurological or musculoskeletal conditions.	4th week
Stroke Impact Scale	The Stroke Impact Scale is a comprehensive assessment tool designed by Duncan et al.specifically for measuring various aspects of health related quality of life in strokes survivors.it consists of 59 items ,each rated on a 5-point likert scale to gauge the level of difficulty experienced by patients.scores are aggregated into different domains ,with a standardized scoring system ranging from 0 to 100 .higher scores reflect a better quality of life across different dimensions impacted by stoke	4th week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Study Chair: Muhammad Kashif, PhD-PT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Estimated): October 5, 2024
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Estimated): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Hand dexterity,Quality of life,Stroke,Transcutaneous vagus nerve stimulation,Upper limb motor function, Virtual reality.
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: REC/RCR & AHS/24/0230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No