Effect of Transcutaneous Vagus Nerve Stimulation on Upper Limb Function in Stroke Patients

NCT06048055 | Completed DMC

• 1 other identifier: taVNS stroke
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Ischemic

Keywords

vagus nerve stimulation; ischemic stroke; taVNS

Outcome Measures

Primary Outcomes (4)

• Changes in upper limb function from baseline to four weeks after the beginning of intervention

  Fugl-Meyer Assessment for upper extremity (FMT-UE).

  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)

  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).

  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.

  four weeks after the beginning of the intervention

Secondary Outcomes (1)

• Changes in gross hand function from baseline to four weeks after the beginning of intervention

  four weeks after the beginning of the intervention

Study Arms (2)

Group 1 (GA)

ACTIVE COMPARATOR

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

Group 2 (GB)

SHAM COMPARATOR

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

Interventions

Transcutaneous auricular vagus nerve stimulation OTHER

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.

Group 1 (GA)

selected physical therapy program OTHER

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.

Group 1 (GA); Group 2 (GB)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemiparetic patients with ischemic middle cerebral artery stroke.
• Duration of illness ranged from at least 6 months after stroke.
• The patient's age ranged from 45 to 65 years.
• Spasticity of upper limb muscles ranged from (grade 1:2) according to the Modified Ashworth scale.
• The patients with unilateral upper limb motor function impairment.
• Patients with sufficient cognitive abilities that enable them to understand and follow instructions.

You may not qualify if:

• Patients with neurological diseases that affect upper limb function other than stroke (e.g.: Multiple sclerosis, Peripheral neuropathy, Parkinsonism….etc.).
• Hemorrhagic stroke patients.
• Patients with previous surgical intervention on the vagus nerve.
• Patients with pacemakers or other implanted electrical devices.
• Patients with a history of significant alcohol or drug abuse.
• Patients with musculoskeletal disorders such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures or contractures of fixed deformity, and leg length discrepancy after total hip replacement.
• Patients with cardiovascular problems (unstable angina, recent myocardial infarction, congestive heart failure, significant heart valve dysfunction, or unstable hypertension) or pulmonary or kidney disorders.
• Patients with visual or auditory impairment affecting their ability to complete the testing.
• Patients with cognitive impairment.
• Any current or past history of facial or ear pain, recent ear trauma, or metal implants above the level of the neck.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy labs at Cairo University

Giza, 12612, Egypt

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Moshera H Darwish, Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: October 1, 2023
• Primary Completion: April 3, 2024
• Study Completion: April 10, 2024
• Last Updated: April 30, 2025

Record last verified: 2024-04

Locations

EG (1)