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Active, not recruitingNCT07822854Updated Sep 16, 2026

Vagal Stimulation in Individuals With Stroke

An interventional study of vagus nerve stimulation and classic rehabilitation in Stroke, Vagus Nerve Stimulation and Motor Function, sponsored by Nermin KART. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Nermin KART · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 484 studies in Stroke with a site in Turkey — 95 open to participants now, 107 under way, 3 of them phase 3. Stroke · Turkey.

Planned enrollment
194th of 320
34 · median 40
Started
2025
with 70 others
No phase
291 of 484
57 open now
Primary completion
2026-12
later than 69 of 106 live
Registered
325th of 484
by date

Among the 484 studies in Stroke with a site in Turkey, this one is the 194th largest by planned enrollment of the 320 interventional ones that give a count, is one of 71 that started in 2025, is one of 291 with no phase, reaches primary completion later than 69 of the 106 other live ones, and was the 325th registered.

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

Browse Stroke studies →

Open to participants now

95 of the 484 studies in Stroke with a site in Turkey are open now. Recruiting first, the newest first:

90 more — sign in →

All 95 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 45 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Stroke
  • Vagus Nerve Stimulation
  • Motor Function
  • Otonomic Function
  • Cognitive Function

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Keywords

  • vagus nerve stimulation
  • stroke
  • vagus
  • motor function
  • otonomic function
  • cognitive function
04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    study group

    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.

    Other: vagus nerve stimulation · Other: classic rehabilitation

  • Active comparator
    control group

    Individuals in this group, consisting of chronic stroke patients, will receive only the standard rehabilitation program without any additional interventions.

    Other: classic rehabilitation

Interventions

  • Othervagus 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

    Also known as: manual vagus nerve stimulation

  • Otherclassic rehabilitation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Week 8

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 8

  2. 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.

    Time frame: Baseline and Week 8

  3. 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.

    Time frame: Baseline and Week 8

  4. Heart Rate

    Time frame: Baseline and Week 8

  5. Systolic Blood Pressure

    Time frame: Baseline and Week 8

  6. Diastolic Blood Pressure

    Time frame: Baseline and Week 8

  7. Oxygen Saturation

    Time frame: Baseline and Week 8

07

Study locations

1 site
  • Nermin Kart
    Sanliurfa, Şanlıurfa 63200, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Dec 2026, 21 months after the start.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 21 months is close to that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2025
First posted
Sep 16, 2026
StartActual
Feb 25, 2025
Primary completionEst.
Dec 1, 2026
CompletionEst.
Jan 1, 2027
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07822854
Lead sponsor
Nermin KART
Responsible party
Nermin KART (lecturer; Principal Investigator, Pamukkale University) — Sponsor-investigator
First posted
Sep 16, 2026
Start date
Feb 25, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Sep 16, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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