Transcutaneous Auricular Vagus Nerve Stimulation on Functional Mobility in People With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Functional mobility
研究概览
简要总结
Parkinson's disease (PD) is characterized by motor impairments such as bradykinesia accompanied by resting tremor and/or rigidity. As PD progresses due to its neurodegenerative nature, complementary strategies must be developed to optimize its effects. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a strategy for controlling the symptoms of the disease. Nevertheless, the efficacy of this approach in managing PD remains to be elucidated. The objective of the present study is to investigate and compare the effects of transcutaneous vagus nerve stimulation (taVNS) and sham taVNS on functional mobility, which is the primary outcome and will be assessed using the Timed Up and Go test. The following tests will be used to evaluate the secondary outcomes: the miniBESTest and the Biodex Balance System (balance), the MDS-UPDRS and the Five-Time Sit-to-Stand Test (motor function), the FOG-Q (freezing of gait), the 10-Meter Walk Test (gait speed), the PGIC (perception of change), and the recording of adverse events. The volunteers will be divided into two groups: one group will receive taVNS in conjunction with physical therapy, while the other group will receive a sham taVNS in conjunction with physical therapy. To assess the effect of therapy, the efficacy of taVNS in enhancing the effects of physical therapy on the functional mobility of people with PD will be evaluated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of PD provided by a neurologist;
- •undergoing regular antiparkinsonian drug treatment (at least three months of regular and stable use);
- •aged 40 years or older;
- •with a Hoehn & Yahr stage of 2.5 to 4.
排除标准
- •other neurological disorders, postural hypotension, vestibular, musculoskeletal, or visual disorders that compromise performance in the proposed tests;
- •other osteomyoarticular diseases in the lower limbs that interfere with performance and locomotion;
- •Montreal Cognitive Assessment (MoCA) score lower than 21 points;
- •previous surgical procedure for PD.
研究组 & 干预措施
Active transcutaneous auricular vagus nerve stimulation
干预措施: Active taVNS (Device)
Sham transcutaneous auricular vagus nerve stimulation
干预措施: Sham taVNS (Device)
结局指标
主要结局
Functional mobility
时间窗: Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30)
Functional mobility will be assessed using the Timed Up and Go (TUG) test. In the TUG, the time taken by the volunteer to perform the activity of getting up from a chair, walking, and sitting back down is timed. The test begins with the volunteer sitting in a chair with their back against the backrest; when asked, they stand up, walk three meters at their fastest speed, but safely, turn around, return to the chair, and sit down. Shorter times in performing this test translate into greater functional mobility. Three repetitions of the test will be scored, and for analysis purposes, the average of the repetitions will be used.
次要结局
- Balance(Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30).)
- Balance(Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30))
- Motor function(Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30))
- Freezing of gait(Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30))
- Speed of gait(Baseline (Day 0), mid-intervention (Day 5), post-intervention (Day 10), 1 month post-intervention (Day 30))
- Patient global impression of change(Post-intervention (Day 10))
- Adverse events(All days of intervention (up to 10 days))
研究者
Kátia Monte-Silva
Professor
Universidade Federal de Pernambuco