NCT06360900招募中不适用
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
Spaulding Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Visceral Sensitivity Index (VSI)
研究概览
简要总结
The study aims at evaluating physiological and patient-reported outcomes for a dual intervention approach including a stimulation device and support therapy in patients with functional dyspepsia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old (inclusive)
- •Ability to give written consent and participate in behavioral intervention in English
- •Willingness to attend weekly treatment sessions over live video, daily self-administered transcutaneous auricular vagus nerve stimulation (taVNS) sessions, and engage in homework during treatment
- •Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session
- •Diagnosis according to the Rome IV criteria for both epigastric pain syndrome and postprandial distress syndrome subtypes
- •Stable medical treatment for functional dyspepsia (FD) during 1 month before the study and during the study period
排除标准
- •Previous receipt of cognitive behavioral therapy (CBT) for gastrointestinal symptoms
- •Enteral or parenteral feeding
- •Previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency, or iron overload disorders
- •Estimated Glomerular Filtration Rate (eGFR) < 60
- •Medications that affect gastrointestinal motility in addition to medications or products containing tetrahydrocannabinol (THC) will be stopped at least 7 days prior to the start of the study and for the duration of the study. However, anti-depressants (SSRI's, TCA's) may be allowed in order to reduce the risk of worsening neuropsychiatric disease, though it will be up to the study team and the Principal Investigator whether subjects on anti-depressants will be able to participate in the study
- •Intellectual disability by history
- •Diabetes, mitochondrial disease, severe autonomic dysfunction, and small fiber polyneuropathy
- •No active clinical acupuncture therapy
- •Illicit drugs or opioid usage
- •History of arrhythmias
- •Current pregnancy/breastfeeding
- •Contraindications for magnetic resonance imaging (MRI) (implanted ferromagnetic objects, claustrophobia)
- •Weight > 450 lbs. (limit of the MRI table)
- •Allergy to pineapple (used in the test meal during MRI)
- •Any other condition interfering with study requirements, according to the Investigator
研究组 & 干预措施
Sensory device + Health Education
Active Comparator
干预措施: Sensory device (Device)
Sensory device + Skills Building
Experimental
干预措施: Sensory device (Device)
Sensory device + Skills Building
Experimental
干预措施: Skills Building (Behavioral)
Sensory device + Health Education
Active Comparator
干预措施: Health Education (Behavioral)
Subsensory device + Skills Building
Active Comparator
干预措施: Skills Building (Behavioral)
Subsensory device + Health Education
Sham Comparator
干预措施: Subsensory device (Device)
Subsensory device + Skills Building
Active Comparator
干预措施: Subsensory device (Device)
Subsensory device + Health Education
Sham Comparator
干预措施: Health Education (Behavioral)
结局指标
主要结局
Visceral Sensitivity Index (VSI)
时间窗: 8 weeks (post-treatment)
GI-related anxiety; score ranging from score ranging from 0 to 75, with higher scores indicating worse outcomes
Visceral Sensitivity Index (VSI)
时间窗: 8 weeks (post-treatment)
GI-related anxiety; score ranging from score ranging from 0 to 75, with higher scores indicating worse outcomes
次要结局
- Gastric peristaltic velocity(8 weeks (post-treatment))
- Gastric peristaltic velocity(8 weeks (post-treatment))
- Nepean Dyspepsia Index (NDI)(8 weeks (post-treatment))
研究者
Roberta Sclocco
Assistant Professor
Spaulding Rehabilitation Hospital
研究点 (2)
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