University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Location status: Recruiting
NCT Number: NCT07276035
The goal of this study is to determine whether stimulation of the brain-stomach connection can influence stomach activity in healthy adults and in individuals suffering from chronic nausea. The main questions it aims to answer are:
* What are the best brain sites to influence the stomach? * What are the effects of different stimulation patterns on stomach activity? * Does the stimulation affect the sensation of nausea in participants suffering from chronic nausea?
Researchers will use a non-invasive method of brain stimulation called Transcranial Magnetic Stimulation (TMS) and will record stomach responses with skin electrodes on the abdomen.
Participants will:
* Visit the clinic at least once, and for up to 9 times more over the course of several months. * Receive TMS while sitting in a chair similar to a dentist's chair. * Drink water or consume a test meal during each study visit.
Interested in participating?
Request Info21 year–60 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15232, United States
Location status: Recruiting
This study will use cutaneous recordings of stomach activity (electrogastrogram, EGG) and non-invasive brain stimulation with Transcranial Magnetic Stimulation (TMS) to
Some clinical, demographic, and autonomic data (i.e. EKG) will be recorded and used as covariates to investigate any systematic impact on the outcome measures.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The best location for evoking an electromyographic (EMG) response of the first dorsal interosseus (FDI) muscle in left and right hand to stimulation of the primary (M1) motor cortex and the minimum stimulation intensity required to evoke a certain EMG response amplitude (Motor Threshold, MT) are determined. This serves as a reference to determine the best location and stimulation parameters to evoke GMEPs from M1 and pre-motor cortical areas.
After identification of the GMEP hot-spot, a stomach filling task (water load test or test meal) is administered and changes in the electrogastrogram (EGG) are monitored.
In subsequent study visits, the stomach filling task is preceded by application of neuromodulatory repetitive TMS (rTMS), targeted to the GMEP hotspot.
Time frame: Baseline session
Location of GMEP hotspot(s) in M1 and/or premotor areas relative to FDI hotspot
Time frame: Each study session through study completion, up to 1 year
Change in spectral power of the EGG in the 3 cpm frequency band associated with the gastric filling task (water load or test meal), either followed or not by neuromodulatory rTMS
Time frame: Each study session through study completion, up to 1 year
Amplitude of GMEPs at hotspot
Time frame: Each study session through study completion, up to 1 year
Volume consumed during the gastric filling task
Time frame: Each study session through study completion, up to 1 year
Nausea severity rating on an 11-point (0-10) Likert-scale (0=none, 10=worst possible)
Contact information is provided by the study sponsor or research team.
David J Levinthal, MD PhD
CONTACT
Elijah D Wright
CONTACT
David Levinthal
Other
TMS Neuromodulation of Brain-to-Stomach Circuits in Chronic Nausea
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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