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Completed
NCT03869372
Cerebral Cortical Influences on Autonomic Function
Conditions: Healthy Subjects, Functional Dyspepsia, Irritable Bowel Syndrome
Sex: All
Ages: 21 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 118
Sponsor: David Levinthal
Location: University of Pittsburgh Medical Center Pittsburgh Pennsylvania
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT03869372). StuddyBuddy aggregates publicly available trial information.