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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Transcutaneous auricular vagus nerve stimulation

selected physical therapy program

About this trial

This is an interventional prevention trial for Stroke, Ischemic focused on measuring vagus nerve stimulation, ischemic stroke, taVNS

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

Faculty of physical therapy labs at Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group 1 (GA)

Group 2 (GB)

Arm Description

Twenty Egyptian male stroke patients will receive 30 minutes of transcutaneous vagal nerve stimulation at tragus of left ear immediately after a 30 minutes session of selected physical therapy program.

Twenty Egyptian male stroke patients will receive 30 minutes of sham vagal nerve stimulation at tragus of left ear immediately after a 30 minutes session of selected physical therapy program.

Outcomes

Primary Outcome Measures

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

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

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)

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).

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.

Secondary Outcome Measures

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

Box and Blocks Test (BBT)

Full Information

NCT ID

NCT06048055

First Posted

September 12, 2023

Last Updated

September 19, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT06048055

Brief Title

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

Official Title

Efficacy of Non Invasive Vagus Nerve Stimulation on Motor Function of Upper Extremity in Chronic Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2023 (Actual)

Primary Completion Date

September 25, 2023 (Anticipated)

Study Completion Date

October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Stroke causes several neurological deficits or impairments as hemiparesis, communication disorders, cognitive deficits or disorders in visuo-spatial perception. Approximately 60% of survivors after stroke suffer from upper limb motor impairment, which lead to loss of independence with poor quality of life. These global economic and social costs of chronic disability due to stroke necessitate the development of new methods beside the conventional treatment to induce neuroplasticity in stroke recovery.Vagus nerve stimulation (VNS) is a neuromodulation therapy, which sends impulses into the neural center to generate corresponding nervous activity. Vagus nerve stimulation is an established treatment in epilepsy, depression, chronic tinnitus, migraine and chronic pain.Vagus nerve stimulation can be invasive or non-invasive. Invasive VNS requires the implantation of a programmable device and electrodes that directly stimulate afferents of the vagus nerve under general anesthesia. Non-invasive method of VNS via transcutaneous stimulation of the peripheral auricular branch of the vagus nerve (taVNS) is safer, better-tolerated method for delivering VNS with the same effect of invasive VNS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Ischemic

Keywords

vagus nerve stimulation, ischemic stroke, taVNS

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (GA)

Arm Type

Active Comparator

Arm Description

Twenty Egyptian male stroke patients will receive 30 minutes of transcutaneous vagal nerve stimulation at tragus of left ear immediately after a 30 minutes session of selected physical therapy program.

Arm Title

Group 2 (GB)

Arm Type

Sham Comparator

Arm Description

Twenty Egyptian male stroke patients will receive 30 minutes of sham vagal nerve stimulation at tragus of left ear immediately after a 30 minutes session of selected physical therapy program.

Intervention Type

Other

Intervention Name(s)

Transcutaneous auricular vagus nerve stimulation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

selected physical therapy program

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

four weeks after the beginning of the intervention

Title

Changes in serum levels of neural plasticity factors from baseline to four weeks after beginning of intervention

Description

serum levels of Brain Derived Neurotrophic Factor (BDNF)

Time Frame

four weeks after the beginning of the intervention

Title

Changes in peak muscle torque of upper limb muscles from baseline to four weeks after the beginning of intervention

Description

Peak muscle torque measured by Biodex System 3 Pro Isokinetic (Biodex Medical Inc., Shirley, New York, USA).

Time Frame

four weeks after the beginning of the intervention

Title

Changes in hand grip strength from baseline to four weeks after the beginning of intervention

Description

Hand grip strength measured by electronic BASELINE hand dynamometer device.

Time Frame

four weeks after the beginning of the intervention

Secondary Outcome Measure Information:

Title

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

Description

Box and Blocks Test (BBT)

Time Frame

four weeks after the beginning of the intervention

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

The study will be applied to ischemic stroke. This type of stroke is more common in males than females in Egypt because most smokers are males. As known, smoking is the major cause of ischemic stroke due to atherosclerotic changes in cerebral blood vessels.

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marwa M Afifi, Assistant Lecturer

Phone

0201005661591

Email

marwamostafa506@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moshera H Darwish, Professor

Organizational Affiliation

Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of physical therapy labs at Cairo University

City

Giza

ZIP/Postal Code

12612

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marwa M Afifi, Assistant lecturer

Phone

0201005661591

Email

marwamostafa506@gmail.com

Stroke, Ischemic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial