StrokeNCT05779293
Effect of Vagus Nerve Stimulation on Chronic Stroke Patients
A study testing Non-invasive auricular vagus nerve stimulation and Conventional therapy in people with Stroke, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Non-invasive auricular vagus nerve stimulation and Conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2023to 5 Oct 2023
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
gamze demircioğlu, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medipol hospital
Istanbul, 34070
HAZAL genç, phd
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Non-invasive auricular vagus nerve stimulation, Conventional therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive auricular vagus nerve stimulationDevice
The only cutaneous nerve of the N. vagus, ramus auricularis, receives sensation from the posterior surface of the auricle, the posterior part of the external auditory canal and the adjacent part of the eardrum. Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. This device non-invasively stimulates the auricular branch of the vagus nerve without any action. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased. The application will take 30 minutes three days a week for four weeks.
Conventional therapyOther
Conventional approaches are approaches that cover range of motion, strength, balance and ambulation training, continuing from passive to resistant exercises.
Neuromuscular electrical stimulation; It is applied to reduce pain, prevent spasticity and strengthen muscles. This newly formed type I fiber functionally shows an increase in resistance to fatigue and a decrease in maximum contraction velocity. The application will take 30 minutes three days a week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| non-invasive auricular vagus nerve stimulation | Experimental | non-invasive auricular vagus nerve stimulation + Neuromuscular Electrical Stimulation (NMES) exercise under the supervision of a physiotherapist Receives: Device: Non-invasive auricular vagus nerve stimulation |
| Conventional physical therapy | Active comparator | NMES exercise under the supervision of a physiotherapist Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brunstrom Hemiplegia Recovery Stages
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
Measured: 4 weeks
Timed Get Up and Go Test
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.
Measured: 4 weeks
Berg Balance Scale
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.
Measured: 4 weeks
The Modified Ashworth Scale,
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
Measured: 4 weeks
Montreal Cognitive Assessment Scale
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.
Measured: 4 weeks
Standardized Mini Mental State Test
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.
Measured: 4 weeks
Secondary outcomes (1)
Stroop test
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start9 Mar 2023
- Primary completion5 Jun 2023 (estimated)
- Study completion5 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779293
- Sponsor's protocol ID
- Stroke
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baig SS, Kamarova M, Ali A, Su L, Dawson J, Redgrave JN, Majid A. Transcutaneous vagus nerve stimulation (tVNS) in stroke: the evidence, challenges and future directions. Auton Neurosci. 2022 Jan;237:102909. doi: 10.1016/j.autneu.2021.102909. Epub 2021 Nov 14.
PubMed 34861612
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vagus Nerve Stimulation on Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05779293
- Acronym / sponsor ID
- Stroke
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 5 Jun 2023 (estimated)
- Study completion
- 5 Oct 2023 (estimated)
- First posted
- 22 Mar 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-invasive auricular vagus nerve stimulation | Experimental | Device: Non-invasive auricular vagus nerve stimulationnon-invasive auricular vagus nerve stimulation + Neuromuscular Electrical Stimulation (NMES) exercise under the supervision of a physiotherapist |
| Conventional physical therapy | Active comparator | Other: Conventional therapyNMES exercise under the supervision of a physiotherapist |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.)
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 |
|---|---|---|
| Non-invasive auricular vagus nerve stimulationThe only cutaneous nerve of the N. vagus, ramus auricularis, receives sensation from the posterior surface of the auricle, the posterior part of the external auditory canal and the adjacent part of the eardrum. Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. This device non-invasively stimulates the auricular branch of the vagus nerve without any action. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased. The application will take 30 minutes three days a week for four weeks. | Device | non-invasive auricular vagus nerve stimulation |
| Conventional therapyConventional approaches are approaches that cover range of motion, strength, balance and ambulation training, continuing from passive to resistant exercises. Neuromuscular electrical stimulation; It is applied to reduce pain, prevent spasticity and strengthen muscles. This newly formed type I fiber functionally shows an increase in resistance to fatigue and a decrease in maximum contraction velocity. The application will take 30 minutes three days a week for four weeks. | Other | Conventional physical therapy |
Primary outcome
Brunstrom Hemiplegia Recovery Stages
Time frame: 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
Timed Get Up and Go Test
Time frame: 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.
Berg Balance Scale
Time frame: 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.
The Modified Ashworth Scale,
Time frame: 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
Montreal Cognitive Assessment Scale
Time frame: 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.
Standardized Mini Mental State Test
Time frame: 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.
1 secondary outcome
Stroop test
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 34861612Baig SS, Kamarova M, Ali A, Su L, Dawson J, Redgrave JN, Majid A. Transcutaneous vagus nerve stimulation (tVNS) in stroke: the evidence, challenges and future directions. Auton Neurosci. 2022 Jan;237:102909. doi: 10.1016/j.autneu.2021.102909. Epub 2021 Nov 14.
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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.
gamze demircioğlu, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive auricular vagus nerve stimulation and Conventional therapy in people with Stroke, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. 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 Turkey (Türkiye). 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HAZAL genç, PhD (05413204291, hazaloksuz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brunstrom Hemiplegia Recovery Stages (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779293, which also lists 1 linked publication.
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 27 Mar 2023.