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Active, not recruiting

NCT Number: NCT07822854

Vagal Stimulation 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.

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognitive Function Motor Function Nervous System Diseases Otonomic Function Vagus Nerve Stimulation Vascular Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nermin Kart

Sanliurfa, Şanlıurfa, 63200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Vagus nerve stimulation

Other

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

Other names: manual vagus nerve stimulation

classic rehabilitation

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Standardized Mini-Mental State Examination Score

    Time frame: Baseline and Week 8

    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.

  2. 4-Meter Walk Test Speed

    Time frame: Baseline and Week 8

    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.

  3. Constipation Severity Scale Score

    Time frame: Baseline and Week 8

    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.

  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

Sponsors and collaborators

Lead sponsor

Nermin KART

Other

Registry information

Official study title

Effects of Manual Vagus Nerve Stimulation on Motor, Autonomic, and Cognitive Functions in Individuals With Stroke

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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