StrokeNCT07822854
Vagal Stimulation in Individuals With Stroke
A study testing vagus nerve stimulation and classic rehabilitation in people with Stroke and Vagus Nerve Stimulation, run by Nermin KART at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of manual vagus nerve stimulation (VNS) on motor, autonomic, and cognitive functions in individuals with chronic stroke. Additionally, researchers will assess the safety of this treatment. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Stroke, Vagus Nerve Stimulation, Motor Function
- What is being tested?
- vagus nerve stimulation and classic rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having experienced an ischemic or hemorrhagic stroke
- Diagnosed with stroke at least six months prior
- No history of multiple stroke episodes
- No communication impairments
- Ability to read and write
Who cannot join
- Presence of hearing loss
- Receiving additional treatment alongside rehabilitation
- Cardiopulmonary disease
- Gastrointestinal disease
- History of a recent trauma
- Presence of neurological disorders other than stroke
- Presence of psychological disorders
- History of a condition that could have previously affected cognitive function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Manual Vagus Nerve Stimulation on Motor, Autonomic, and Cognitive Functions in Individuals With Stroke
The aim of this study is to investigate the effects of manual vagus nerve stimulation (VNS) on motor, autonomic, and cognitive functions in individuals with chronic stroke. Additionally, researchers will assess the safety of this treatment. The primary research questions that this study aims to address are as follows:
Does manual vagus nerve stimulation improve motor function in individuals with chronic stroke? Does manual vagus nerve stimulation influence autonomic functions in individuals with chronic stroke? Does manual vagus nerve stimulation accelerate cognitive recovery in individuals with chronic stroke? Researchers will compare the effects of manual vagus nerve stimulation with a standard rehabilitation program.
Read more
Participants in the experimental group will receive manual vagus nerve stimulation three times a week for eight weeks, in addition to the standard rehabilitation program. Participants in the control group will receive only the standard rehabilitation program.
Each participant will:
Attend clinical assessments and evaluation tests. Have their motor skills, autonomic function, and cognitive status recorded at the beginning of the treatment and at the end of the eight-week intervention period.
This study will contribute to a better understanding of the potential of manual vagus nerve stimulation as a novel therapeutic approach for individuals with stroke.
- Being tested
- vagus nerve stimulation, classic rehabilitation
- Keywords
- vagus nerve stimulation, stroke, vagus, motor function, otonomic function, cognitive function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vagus nerve stimulationOther
Also called manual vagus nerve stimulation
Manual Vagus Nerve Stimulation (mVNS)
Manual vagus nerve stimulation (mVNS) is a non-invasive, accessible, and cost-effective alternative to electrical vagus nerve stimulation (VNS). Unlike invasive methods, mVNS targets key vagal pathways through manual techniques that aim to modulate autonomic function, enhance neuroplasticity, and promote recovery.
This study applies mVNS twice a week for eight weeks, using the following techniques:
Suboccipital Inhibition Technique: Both hands are placed under the occiput, applying deep, gliding, and progressive pressure for 10 minutes to relax suboccipital muscles.
Fourth Ventricle Technique: Hands are positioned under the occiput, applying cephalic traction for 10 minutes to aid autonomic nervous system balance.
Diaphragm Release: Hands are placed bilaterally on the anterior lower ribs, applying gentle traction during inspiration and pressure during expiration.
Carotid Sinus Massage: Mechanical pressure is applied above the thyroid cartilag
classic rehabilitationOther
Passive and Active Joint Movements: Applied to maintain joint range of motion and prevent contractures.
Muscle Strengthening Exercises: Isometric, isotonic, and resistance exercises are used to strengthen weakened muscle groups.
Balance and Gait Training: Supported by proprioceptive exercises and weight-shifting techniques.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | The participants in the study group consist of individuals with chronic stroke. In addition to the standard rehabilitation program, these individuals will receive manual vagus nerve stimulation (mVNS) as part of the intervention. Receives: Other: vagus nerve stimulation; Other: classic rehabilitation |
| control group | Active comparator | Individuals in this group, consisting of chronic stroke patients, will receive only the standard rehabilitation program without any additional interventions. Receives: Other: classic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Motor Assessment Total Score
Motor function will be assessed using the Fugl-Meyer Motor Assessment (FMA). The scale evaluates motor recovery of the upper and lower extremities in individuals with stroke. Total scores range from 0 to 100, with higher scores indicating better motor function.
Measured: Baseline and Week 8
Secondary outcomes (7)
Standardized Mini-Mental State Examination Score
Cognitive function will be assessed using the Standardized Mini-Mental State Examination (SMMSE). The total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline and Week 8
4-Meter Walk Test Speed
Walking speed will be assessed using the 4-Meter Walk Test (4MWT). Participants will be instructed to walk a distance of 4 meters, and walking speed will be calculated in meters per second (m/s). Higher walking speed values indicate better walking performance.
Measured: Baseline and Week 8
Constipation Severity Scale Score
Constipation severity will be assessed using the Constipation Severity Scale (CSS). The total score ranges from 0 to 73, with higher scores indicating greater severity of constipation symptoms and therefore a worse outcome.
Measured: Baseline and Week 8
Heart Rate
Measured: Baseline and Week 8
Systolic Blood Pressure
Measured: Baseline and Week 8
Diastolic Blood Pressure
Measured: Baseline and Week 8
Oxygen Saturation
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start25 Feb 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Model Explanation This study employs a randomized controlled trial (RCT) design to assess the effects of manual vagus nerve stimulation (mVNS) in individuals with chronic stroke. Participants will be randomly allocated into two groups using a computer-generated randomization process to ensure an unbiased distribution of baseline characteristics. Study Group: Participants in this group will receive manual vagus nerve stimulation (mVNS) in addition to the standard rehabilitation program. mVNS will be applied three times per week for eight weeks alongside conventional therapy. Control Group: Participants in this group will undergo only the standard rehabilitation program, serving as a comparative benchmark to assess the added effects of mVNS. Both groups will be evaluated at baseline and post-intervention (after eight weeks) using standardized assessments for motor function, autonomic function, and cognitive performance. The study design incorporates blinded outcome assessments.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nermin KART
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nermin KART, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822854
- Sponsor's protocol ID
- NKnkNK1994.
- Status last verified
- Sep 2026
- First submitted
- 12 Mar 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Vagus Nerve Stimulation on Motor, Autonomic, and Cognitive Functions in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT07822854
- Acronym / sponsor ID
- NKnkNK1994.
- Keywords
- vagus nerve stimulation, stroke, vagus, motor function, otonomic function, cognitive function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Nermin KARTUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 16 Sep 2026 (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 aim of this study is to investigate the effects of manual vagus nerve stimulation (VNS) on motor, autonomic, and cognitive functions in individuals with chronic stroke. Additionally, researchers will assess the safety of this treatment. The primary research questions that this study aims to address are as follows:
Does manual vagus nerve stimulation improve motor function in individuals with chronic stroke? Does manual vagus nerve stimulation influence autonomic functions in individuals with chronic stroke? Does manual vagus nerve stimulation accelerate cognitive recovery in individuals with chronic stroke? Researchers will compare the effects of manual vagus nerve stimulation with a standard rehabilitation program.
Participants in the experimental group will receive manual vagus nerve stimulation three times a week for eight weeks, in addition to the standard rehabilitation program. Participants in the control group will receive only the standard rehabilitation program.
Each participant will:
Attend clinical assessments and evaluation tests. Have their motor skills, autonomic function, and cognitive status recorded at the beginning of the treatment and at the end of the eight-week intervention period.
This study will contribute to a better understanding of the potential of manual vagus nerve stimulation as a novel therapeutic approach for individuals with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Model Explanation This study employs a randomized controlled trial (RCT) design to assess the effects of manual vagus nerve stimulation (mVNS) in individuals with chronic stroke. Participants will be randomly allocated into two groups using a computer-generated randomization process to ensure an unbiased distribution of baseline characteristics. Study Group: Participants in this group will receive manual vagus nerve stimulation (mVNS) in addition to the standard rehabilitation program. mVNS will be applied three times per week for eight weeks alongside conventional therapy. Control Group: Participants in this group will undergo only the standard rehabilitation program, serving as a comparative benchmark to assess the added effects of mVNS. Both groups will be evaluated at baseline and post-intervention (after eight weeks) using standardized assessments for motor function, autonomic function, and cognitive performance. The study design incorporates blinded outcome assessments.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: vagus nerve stimulation, Other: classic rehabilitationThe participants in the study group consist of individuals with chronic stroke. In addition to the standard rehabilitation program, these individuals will receive manual vagus nerve stimulation (mVNS) as part of the intervention. |
| control group | Active comparator | Other: classic rehabilitationIndividuals in this group, consisting of chronic stroke patients, will receive only the standard rehabilitation program without any additional interventions. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having experienced an ischemic or hemorrhagic stroke
- Diagnosed with stroke at least six months prior
- No history of multiple stroke episodes
- No communication impairments
- Ability to read and write
Key exclusion criteria (8 listed)
- Presence of hearing loss
- Receiving additional treatment alongside rehabilitation
- Cardiopulmonary disease
- Gastrointestinal disease
- History of a recent trauma
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 |
|---|---|---|
| vagus nerve stimulationAlso: manual vagus nerve stimulationManual Vagus Nerve Stimulation (mVNS) Manual vagus nerve stimulation (mVNS) is a non-invasive, accessible, and cost-effective alternative to electrical vagus nerve stimulation (VNS). Unlike invasive methods, mVNS targets key vagal pathways through manual techniques that aim to modulate autonomic function, enhance neuroplasticity, and promote recovery. This study applies mVNS twice a week for eight weeks, using the following techniques: Suboccipital Inhibition Technique: Both hands are placed under the occiput, applying deep, gliding, and progressive pressure for 10 minutes to relax suboccipital muscles. Fourth Ventricle Technique: Hands are positioned under the occiput, applying cephalic traction for 10 minutes to aid autonomic nervous system balance. Diaphragm Release: Hands are placed bilaterally on the anterior lower ribs, applying gentle traction during inspiration and pressure during expiration. Carotid Sinus Massage: Mechanical pressure is applied above the thyroid cartilag | Other | study group |
| classic rehabilitationPassive and Active Joint Movements: Applied to maintain joint range of motion and prevent contractures. Muscle Strengthening Exercises: Isometric, isotonic, and resistance exercises are used to strengthen weakened muscle groups. Balance and Gait Training: Supported by proprioceptive exercises and weight-shifting techniques. | Other | control group, study group |
Primary outcome
Fugl-Meyer Motor Assessment Total Score
Time frame: Baseline and Week 8
Motor function will be assessed using the Fugl-Meyer Motor Assessment (FMA). The scale evaluates motor recovery of the upper and lower extremities in individuals with stroke. Total scores range from 0 to 100, with higher scores indicating better motor function.
7 secondary outcomes
Standardized Mini-Mental State Examination Score
Time frame: Baseline and Week 8
4-Meter Walk Test Speed
Time frame: Baseline and Week 8
Constipation Severity Scale Score
Time frame: Baseline and Week 8
Heart Rate
Time frame: Baseline and Week 8
Systolic Blood Pressure
Time frame: Baseline and Week 8
Diastolic Blood Pressure
Time frame: Baseline and Week 8
Oxygen Saturation
Time frame: Baseline and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vagus nerve stimulation and classic rehabilitation in people with Stroke and Vagus Nerve Stimulation, run by Nermin KART 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 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Fugl-Meyer Motor Assessment Total Score (time frame: Baseline and Week 8). 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 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.