Vagal Stimulation in Individuals With Stroke

NCT07822854 | Active Not Recruiting DMC

• 1 other identifier: NKnkNK1994.
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

vagus nerve stimulation; stroke; vagus; motor function; otonomic function; cognitive function

Outcome Measures

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.

  Baseline and Week 8

Secondary Outcomes (7)

• Standardized Mini-Mental State Examination Score

  Baseline and Week 8

• 4-Meter Walk Test Speed

  Baseline and Week 8

• Constipation Severity Scale Score

  Baseline and Week 8

• Heart Rate

  Baseline and Week 8

• Systolic Blood Pressure

  Baseline and Week 8

Study Arms (2)

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.

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.

Other: classic rehabilitation

Interventions

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

Also known as: manual vagus nerve stimulation

study group

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.

control group; study group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nermin KART: lead

Study Sites (1)

Nermin Kart

Sanliurfa, Şanlıurfa, 63200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer; Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: September 16, 2026
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

TU (1)