Effects of Manual Vagus Nerve Stimulation on Motor, Autonomic, and Cognitive Functions in Individuals With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Motor Assessment Total Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: vagus nerve stimulation (Other)
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.
干预措施: classic rehabilitation (Other)
control group
Individuals in this group, consisting of chronic stroke patients, will receive only the standard rehabilitation program without any additional interventions.
干预措施: classic rehabilitation (Other)
结局指标
主要结局
Fugl-Meyer Motor Assessment Total Score
时间窗: 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.
次要结局
- 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)
- Diastolic Blood Pressure(Baseline and Week 8)
- Oxygen Saturation(Baseline and Week 8)
研究者
Nermin KART
lecturer; Principal Investigator
Pamukkale University