Stroke, IschemicNCT05809037
Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke
A study testing transcutaneous auricular vagus nerve stimulation in people with Stroke, Ischemic and Hemiplegia, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effectiveness of vagus nerve stimulation in patients with right and left hemiparesis will be compared with each other and with the sham application. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke, Ischemic, Hemiplegia, Hemiparesis;Poststroke/CVA
- What is being tested?
- transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2023to 27 Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of subacute-chronic ischemic stroke (3-12 months)
Who cannot join
- Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy).
- Severe depression (Beck Depression Scale > 29)
- Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
- Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline.
- Pregnancy or planning to become pregnant or breastfeed during the study period.
- Botox injections or hemiplegia rehabilitation within 6 months before treatment.
- Having a history of hemorrhagic stroke
- Presence of ongoing dysphagia or aspiration difficulties.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Physical Medicine and Rehabilitation Training and research Hospital
Istanbul
Selim Sezikli, MD, +902124965000, selimsezikli@hotmail.com
About this study
In this study, the effectiveness of vagus nerve stimulation in patients with right and left hemiparesis will be compared with each other and with the sham application.
Read the detailed description
This prospective study will include 80 participants with a diagnosis of ischemic stroke who meet the inclusion criteria. In addition to the conventional rehabilitation program, non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, noninvasive auricular stimulation will be applied, stimulation frequency is 10 Hz, the pulse width is 300 µs, biphasic. In the study, sham vagus nerve stimulation (0 mA) will be applied to the participants in the control group. The study will be completed when the evaluation of the participants is made in the 1st and 3rd months after the last intervention. The upper extremity functions of the patients participating in the study were determined by Fugl-Meyer upper extremity test and box and block test, upper and lower extremity spasticities by modified Ashworth scale, and sleep quality by Pittsburgh sleep quality index. Quality of life will be evaluated with the stroke-specific quality of life scale, balance functions with the Berg balance test, dependency levels in daily activities with the Barthel index, and sympathetic dysfunctions with COMPASS-31. Participants' blood pressure and pulse values will be evaluated before and after each session.
- Conditions
- Stroke, Ischemic, Hemiplegia, Hemiparesis;Poststroke/CVA
- Being tested
- transcutaneous auricular vagus nerve stimulation, Sham stimulation
- Medical subject headings
- Ischemic Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulationDevice
In addition to the conventional rehabilitation program, non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, noninvasive auricular stimulation will be applied, stimulation frequency is 10 Hz, pulse width is 300 µs, and biphasic.
Sham stimulationDevice
In addition to the conventional rehabilitation program, sham vagus nerve stimulation (0 mA) will be applied to the participants in the control group. Non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, and noninvasive auricular stimulation will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation for right hemiparesis patients | Active comparator | Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Sham Stimulation for right hemiparesis patients | Sham comparator | Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis Receives: Device: Sham stimulation |
| Active Stimulation for left hemiparesis patients | Active comparator | Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Sham Stimulation for left hemiparesis patients | Sham comparator | Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for Upper Extremity
It is considered as gold standard and is the only impairment level measure recommended for stroke trials. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).
Measured: Change from Baseline Fugl-Meyer Assessment for Upper Extremity at 4 weeks and 12 weeks
Stroke-Specific Quality of Life Scale
The Stroke-Specific Quality of Life Scale assesses health-related quality of life specific to stroke survivors. 49 questions under 12 subscales. Scores range from 49-245. Higher scores indicate better functioning.
Measured: Change from Baseline Stroke-Specific Quality of Life Scale at 4 weeks and 12 weeks
Secondary outcomes (5)
Barthel Index
Barthel Index is used to measure the disability experienced by the patient in performing activities of daily living. It comprises 10 items regarding activities of daily living and mobility and assesses feeding, transfer from wheelchair to bed and back, self-care, bathing, walking, climbing stairs, dressing, and bladder and bowel continence. Scoring is based on whether the patient requires help or not in performing any of the above mentioned activities. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.
Measured: Change from Baseline Barthel Index at 4 weeks and 12 weeks
Modified Ashworth Scale
Modified Ashworth Scale (MAS) is used to assess spasticity. Scoring: 0: No increase in tone; 1: slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension; 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ); 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed; 3: considerable increase in tone, passive movement difficult and, 4: limb rigid in flexion or extension
Measured: Change from Baseline Modified Ashworth Scale at 4 weeks and 12 weeks
Berg Balance Test
Berg Balance Test is consisting of 14 items and measures the ability of individuals to maintain balance while performing functional tasks. Each task is scored from 0 (cannot perform independently) to 4 (stated best performance). 0-20 points are interpreted as high risk of falling, between 21-40 points as medium risk of falling, and between 41-56 points as low risk.
Measured: Change from Baseline Berg Balance Test at 4 weeks and 12 weeks
Composite Autonomic Symptom Score (COMPASS-31)
The test has 6 domains looking at autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. The six domain scores sum to a total COMPASS 31 score of 0 to 100, and a higher COMPASS 31 score indicates more severe autonomic symptoms.
Measured: Change from Baseline Composite Autonomic Symptom Score at 4 weeks and 12 weeks
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: Change from Baseline Pittsburgh Sleep Quality Index at 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start27 Mar 2023
- Primary completion27 Dec 2023 (estimated)
- Study completion27 Mar 2024 (estimated)
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Selim Sezikli, MD, Principal investigator, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809037
- Sponsor's protocol ID
- 2022/382
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05809037
- Acronym / sponsor ID
- 2022/382
- Conditions
- Stroke, Ischemic, Hemiplegia, Hemiparesis;Poststroke/CVA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 27 Dec 2023 (estimated)
- Study completion
- 27 Mar 2024 (estimated)
- First posted
- 12 Apr 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.
In this study, the effectiveness of vagus nerve stimulation in patients with right and left hemiparesis will be compared with each other and with the sham application.
Detailed description
This prospective study will include 80 participants with a diagnosis of ischemic stroke who meet the inclusion criteria. In addition to the conventional rehabilitation program, non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, noninvasive auricular stimulation will be applied, stimulation frequency is 10 Hz, the pulse width is 300 µs, biphasic. In the study, sham vagus nerve stimulation (0 mA) will be applied to the participants in the control group. The study will be completed when the evaluation of the participants is made in the 1st and 3rd months after the last intervention. The upper extremity functions of the patients participating in the study were determined by Fugl-Meyer upper extremity test and box and block test, upper and lower extremity spasticities by modified Ashworth scale, and sleep quality by Pittsburgh sleep quality index. Quality of life will be evaluated with the stroke-specific quality of life scale, balance functions with the Berg balance test, dependency levels in daily activities with the Barthel index, and sympathetic dysfunctions with COMPASS-31. Participants' blood pressure and pulse values will be evaluated before and after each session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation for right hemiparesis patients | Active comparator | Device: transcutaneous auricular vagus nerve stimulationActive non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis |
| Sham Stimulation for right hemiparesis patients | Sham comparator | Device: Sham stimulationSham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis |
| Active Stimulation for left hemiparesis patients | Active comparator | Device: transcutaneous auricular vagus nerve stimulationActive non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis |
| Sham Stimulation for left hemiparesis patients | Sham comparator | Device: Sham stimulationSham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of subacute-chronic ischemic stroke (3-12 months)
Key exclusion criteria (8 listed)
- Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy).
- Severe depression (Beck Depression Scale > 29)
- Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
- Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline.
- Pregnancy or planning to become pregnant or breastfeed during the study period.
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 stimulationIn addition to the conventional rehabilitation program, non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, noninvasive auricular stimulation will be applied, stimulation frequency is 10 Hz, pulse width is 300 µs, and biphasic. | Device | Active Stimulation for left hemiparesis patients, Active Stimulation for right hemiparesis patients |
| Sham stimulationIn addition to the conventional rehabilitation program, sham vagus nerve stimulation (0 mA) will be applied to the participants in the control group. Non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, and noninvasive auricular stimulation will be applied. | Device | Sham Stimulation for left hemiparesis patients, Sham Stimulation for right hemiparesis patients |
Primary outcome
Fugl-Meyer Assessment for Upper Extremity
Time frame: Change from Baseline Fugl-Meyer Assessment for Upper Extremity at 4 weeks and 12 weeks
It is considered as gold standard and is the only impairment level measure recommended for stroke trials. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).
Stroke-Specific Quality of Life Scale
Time frame: Change from Baseline Stroke-Specific Quality of Life Scale at 4 weeks and 12 weeks
The Stroke-Specific Quality of Life Scale assesses health-related quality of life specific to stroke survivors. 49 questions under 12 subscales. Scores range from 49-245. Higher scores indicate better functioning.
5 secondary outcomes
Barthel Index
Time frame: Change from Baseline Barthel Index at 4 weeks and 12 weeks
Modified Ashworth Scale
Time frame: Change from Baseline Modified Ashworth Scale at 4 weeks and 12 weeks
Berg Balance Test
Time frame: Change from Baseline Berg Balance Test at 4 weeks and 12 weeks
Composite Autonomic Symptom Score (COMPASS-31)
Time frame: Change from Baseline Composite Autonomic Symptom Score at 4 weeks and 12 weeks
Pittsburgh Sleep Quality Index
Time frame: Change from Baseline Pittsburgh Sleep Quality Index at 4 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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.
Selim Sezikli, MD principal investigator
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
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 in people with Stroke, Ischemic and Hemiplegia, run by Istanbul Physical Medicine Rehabilitation Training and Research 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 1 inclusion and 8 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 12 Apr 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Selim Sezikli, MD (+902124965000, selimsezikli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment for Upper Extremity (time frame: Change from Baseline Fugl-Meyer Assessment for Upper Extremity at 4 weeks and 12 weeks). The study lists 2 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 12 Apr 2023.