CompletedNot Applicable

Cerebral Cortical Influences on Autonomic Function

United States118 participantsStarted 2019-04-05

Plain-language summary

This is an exploratory neurophysiological study that will determine the impact of non-invasive brain stimulation on autonomic regulation, with a focus on gastrointestinal function. These studies should provide a basis for future brain-based neurotherapeutic strategies in patients with functional GI disorders.

Who can participate

Age range

21 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults between age 21 and 60 * Participants without gastrointestinal symptoms (Healthy Subjects) * Participants with gastrointestinal symptoms compatible with functional dyspepsia (FD) and or irritable bowel syndrome (IBS) Exclusion Criteria: * history of myocardial infarction, supplemental oxygen requirement, or diabetes * history of chronic gastrointestinal symptoms (for healthy subjects only) * history of gastric surgery * psychosis or altered cognitive status * history of head injury, metal in the skull, stroke, or a history of seizures * implantable devices, such as a pacemaker or nerve stimulator * current use of the following medications or use of substances which are known to lower the seizure threshold: amitriptyline (Elavil), nortriptyline (Pamelor), imipramine (Tofranil), doxepin (Sinequan), clozapine (Clozaril), chlorpromazine (Thorazine), amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/phencyclidine (PCP), cocaine, or 3 or more alcoholic drinks per day * pregnancy * Body-Mass-Index (BMI) \> 35

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Electrogastrogram (EGG)

Timeframe: EGG will be monitored for 15 minutes before and up to 1 hour after consumption of the nutrient drink or the test meal

Volume threshold to satiety

Timeframe: volumes will be determined immediately after the 5 min drinking window and compared across study sessions

Trial details

NCT IDNCT03869372

SponsorDavid Levinthal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-03

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