Status:
ACTIVE_NOT_RECRUITING
Cerebral Cortical Influences on Autonomic Function
Lead Sponsor:
David Levinthal
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Subjects
Functional Dyspepsia
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief 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 shoul...
Detailed Description
The overall goal of this study is to determine the impact of non-invasive brain stimulation on autonomic function in human subjects without functional gastrointestinal disorders and in subjects with I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 3 2026
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT03869372
Start Date
April 5 2019
End Date
October 3 2026
Last Update
October 31 2025
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232