Ameliorating Effects and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Constipation in Parkinson's Disease Patients: a Randomized, Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- alterations in complete spontaneous bowel movements per week (CSBMs/week)
研究概览
简要总结
The investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (HRAM), to investigate the improvement effect of taVNS on constipation symptoms in PD patients.
详细描述
The investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (HRAM), to investigate the improvement effect of taVNS on constipation symptoms in PD patients. Meanwhile, the investigators aimed to verify mechanistic effects by investigating changes in proteins and cytokines related to inflammation and intestinal barrier function in serum and feces to verify mechanistic effects.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 40-70 years;
- •had a PD diagnosis designated by movement disorder neurologists (Ke-zhong Zhang and Yong-sheng Yuan) according to Movement Disorder Society Clinical Diagnostic Criteria;
- •fulfilled Rome IV criteria for functional constipation, including having < 3 spontaneous bowel movements (SBM; i.e., not induced by rescue medication) per week for the past 3 months with symptom duration of at least 6 months;
- •stable initiation of PD medications, leastways 3 month before this investigation; (5) provided written informed consent.
排除标准
- •a history of previous abdominal surgery (other than appendectomy);
- •the presence of carcinoma;
- •any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, or spinal cord injury;
- •taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors;
- •a serious concomitant disease of the heart, liver, kidney, or diabetes;
- •pregnancy or lactation;
- •participating in another trial or enrolled in a trial during the past month;
- •an allergic reaction to surface electrodes.
结局指标
主要结局
alterations in complete spontaneous bowel movements per week (CSBMs/week)
时间窗: Assessed at 2 weeks before baseline, 2 weeks before the last day of intervention
By having patients record their bowel movements two weeks before the start of the experiment and two weeks before the end of the experiment, calculate the CSBMs/week.
次要结局
- Change from Baseline Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) at one day post intervention(Assessed at baseline, one day post intervention)
- Change from Baseline Gastrointestinal Symptoms Rating Scales at one day post intervention(Assessed at baseline, one day post intervention)
- Change from Baseline constipation symptoms scores at one day post intervention(Assessed at baseline, one day post intervention)
- Change from Baseline Patient Assessment of Constipation Quality of Life scale，PAC-QOL at one day post intervention(Assessed at baseline, one day post intervention)
- Change from Baseline Patient Assessment of Constipation Symptoms questionnaire at one day post intervention(Assessed at baseline, one day post intervention)
- Change from Baseline HRAM at one day post intervention--Resting pressure (mmHg)(Assessed at baseline, one day post intervention)
- Change from Baseline HRAM at one day post intervention--maximum squeeze pressure (mmHg)(Assessed at baseline, one day post intervention)
- Change from Baseline HRAM at one day post intervention--First sensation (mL)(Assessed at baseline, one day post intervention)
- Change from Baseline HRAM at one day post intervention--desire to defecate threshold(Assessed at baseline, one day post intervention)
- Change from Baseline HRAM at one day post intervention--maximum tolerance(Assessed at baseline, one day post intervention)
- Change from Baseline gastrointestinal electrogram at one day post intervention--amplitude(Assessed at baseline, one day post intervention)
- Change from Baseline gastrointestinal electrogram at one day post intervention--frequency(Assessed at baseline, one day post intervention)
- Change from Baseline serum indicators at one day post intervention(Assessed at baseline, one day post intervention)
- Change from Baseline feces indicators at one day post intervention(Assessed at baseline, one day post intervention)
- Change from Baseline The motor part of the Unified Parkinson's Disease Rating Scale at one day post intervention(Assessed at baseline, one day post intervention)
研究者
Kezhong Zhang
Professor
The First Affiliated Hospital with Nanjing Medical University