Stroke, IschemicNCT06048055
Effect of Transcutaneous Vagus Nerve Stimulation on Upper Limb Function in Stroke Patients
A study testing Transcutaneous auricular vagus nerve stimulation and selected physical therapy program in people with Stroke, Ischemic, run by Cairo University at 1 site in Egypt.
Trial 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?… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Transcutaneous auricular vagus nerve stimulation and selected physical therapy program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 10 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Non Invasive Vagus Nerve Stimulation on Motor Function of Upper Extremity in Chronic Stroke Patients
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.
Read the 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.
- Conditions
- Stroke, Ischemic
- Being tested
- Transcutaneous auricular vagus nerve stimulation, selected physical therapy program
- Keywords
- vagus nerve stimulation, ischemic stroke, taVNS
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular vagus nerve stimulationOther
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.
selected physical therapy programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in upper limb function from baseline to four weeks after the beginning of intervention
Fugl-Meyer Assessment for upper extremity (FMT-UE).
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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
Box and Blocks Test (BBT)
Measured: four weeks after the beginning of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2023
- Primary completion3 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mostafa Abdel Moneim Afifi, Cairo University
- Investigators
- Moshera H Darwish, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048055
- Sponsor's protocol ID
- taVNS stroke
- Status last verified
- Apr 2024
- First submitted
- 12 Sep 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Non Invasive Vagus Nerve Stimulation on Motor Function of Upper Extremity in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06048055
- Acronym / sponsor ID
- taVNS stroke
- Conditions
- Stroke, Ischemic
- Keywords
- vagus nerve stimulation, ischemic stroke, taVNS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (GA) | Active comparator | Other: Transcutaneous auricular vagus nerve stimulation, Other: selected physical therapy programTwenty 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. |
| Group 2 (GB) | Sham comparator | Other: selected physical therapy programTwenty 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulationPatients 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. | Other | Group 1 (GA) |
| selected physical therapy programThe 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. | Other | Group 1 (GA), Group 2 (GB) |
Primary outcome
Changes in upper limb function from baseline to four weeks after the beginning of intervention
Time frame: four weeks after the beginning of the 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
Time frame: four weeks after the beginning of the 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
Time frame: four weeks after the beginning of the 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
Time frame: four weeks after the beginning of the intervention
Hand grip strength measured by electronic BASELINE hand dynamometer device.
1 secondary outcome
Changes in gross hand function from baseline to four weeks after the beginning of intervention
Time frame: four weeks after the beginning of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshera H Darwish, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous auricular vagus nerve stimulation and selected physical therapy program in people with Stroke, Ischemic, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in upper limb function from baseline to four weeks after the beginning of intervention (time frame: four weeks after the beginning of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.