Cognitive Function, Motor Function, Otonomic Function, Stroke, Vagus Nerve Stimulation
Conditions
Keywords
vagus nerve stimulation, stroke, vagus, motor function, otonomic function, cognitive function
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.
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
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.
Sponsors
Nermin KART
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Motor Assessment Total Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Standardized Mini-Mental State Examination Score | 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. |
| 4-Meter Walk Test Speed | 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. |
| Constipation Severity Scale Score | 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. |
| Heart Rate | Baseline and Week 8 | — |
| Systolic Blood Pressure | Baseline and Week 8 | — |
| Diastolic Blood Pressure | Baseline and Week 8 | — |
| Oxygen Saturation | Baseline and Week 8 | — |
Countries
Turkey (Türkiye)
Outcome results
None listed