GI-Challenge Study for Gastroparesis Patients and Healthy Controls
Megadott ok: Study was stopped due to technical issues with the ANSAR equipment, lack of research personnel caused by COVID-19 restrictions imposed at our site, and recent departure of the PI and study chair from our research institute.
A legfontosabb adatok
- Hol
- Palo Alto (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- Stanford University Medical CenterPalo Alto, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Stanford University
- Azonosító
- NCT03896126
- A regiszteradat frissítve
- 2025. szeptember 4.
- Eredeti leírás
Gastroparesis Patients and Healthy Controls ages 20-49 will be asked to participate in an observational study measuring vagal activity following food ingestion in order to establish parameters of autonomic nerve/vagal function in healthy human subjects compared to those with gastroparesis. Information generated from this study may be used in the future to establish what is normal and abnormal enteric vagal tone and how much vagal nerve stimulation treatment may be required to help patients with gastroparesis.A teljes eredeti leírásKevesebb
Instantaneous Measures of Autonomic Nervous System Responses to Gastrointestinal Challenges
Gastroparesis Patients and Healthy Controls ages 20-49 will be asked to participate in an observational study measuring vagal activity following food ingestion in order to establish parameters of autonomic nerve/vagal function in healthy human subjects compared to those with gastroparesis. Information generated from this study may be used in the future to establish what is normal and abnormal enteric vagal tone and how much vagal nerve stimulation treatment may be required to help patients with gastroparesis.
Bevonási feltételek: Male or female; Age 20-49 years old; Healthy volunteer or established diagnosis of idiopathic gastroparesis as per AGA (American Gastroenterology Association) guidelines; Participant is capable of giving informed consent; Gastroparesis patients must be on stable doses of medications for gastroparesis for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).
Kizáró feltételek: Surgical-related gastroparesis; Use of narcotic pain medications in the preceding 2 weeks of study enrollment; Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, pyloroplasty, or gastric bypass; Patients with severe disease flare requiring hospitalization or frequent emergency room visits (last within 3 months or less of enrollment); History of gastric pacemaker implantation; Dairy, wheat, or egg allergy/intolerance; Allergy to commercial clinical adhesive for EKG stickers; Diagnosis of systemic autonomic nerve dysfunction (i.e. POTS, CAN); Extrinsic myopathy or neuropathy causing gastroparesis; Patients with enteric feeding tubes or requiring parenteral nutrition; Untreated significant depression or suicidal thoughts; Pregnant or breast-feeding women; Patients with implantable electronic devices; Non-English speaker and/or hearing impaired (as participants need to follow English verbal commands and cues for the experiment).