Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
155 participants
INTERVENTIONAL
2023-06-17
2026-12-31
Brief Summary
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Detailed Description
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Aim 1: Determine the optimal stimulation parameters and the optimal location for eliciting GEPs in cortical motor areas.
Aim 2: Determine whether various modes of repetitive TMS (rTMS) neuromodulation targeted to GEP hotspots shape gastric motor responses to a water load.
The investigators will record some clinical, demographic, and autonomic data (i.e. EKG) in our enrolled subjects. Secondary analyses will use these variables as covariates to investigate any systematic impact on the measures from Aims 1 and 2.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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All participants
All participants
Transcranial Magnetic Stimulation, TMS
The best location for evoking an electromyographic (EMG) response of the first dorsal interosseus (FDI) muscle in the dominant hand and the minimum stimulation intensity required to evoke a certain EMG response amplitude (Motor Threshold, MT) are used as reference to determine the best location and stimulation parameters to evoke GEPs.
After identification of the GEP hot-spot, a water load test is administered to determine whether satiety shapes GEP responses.
In subsequent study visits, the water load test is preceded by application of neuromodulatory repetitive TMS (rTMS), targeted to the GEP hotspot.
Interventions
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Transcranial Magnetic Stimulation, TMS
The best location for evoking an electromyographic (EMG) response of the first dorsal interosseus (FDI) muscle in the dominant hand and the minimum stimulation intensity required to evoke a certain EMG response amplitude (Motor Threshold, MT) are used as reference to determine the best location and stimulation parameters to evoke GEPs.
After identification of the GEP hot-spot, a water load test is administered to determine whether satiety shapes GEP responses.
In subsequent study visits, the water load test is preceded by application of neuromodulatory repetitive TMS (rTMS), targeted to the GEP hotspot.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* history of head injury, metal in the skull, stroke, or a history of seizures, loss of consciousness or syncope
* implantable devices, such as a pacemaker or nerve stimulator
* current use of antiepileptic medications or current use of the following medications or substances which are known to lower the seizure threshold: Clozapine (Clozaril), Chlorpromazine (Thorazine), amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or 3 or more alcoholic drinks per day
* pregnancy
* BMI \> 30
* history of bariatric surgery such as sleeve gastrectomy or Roux-en-Y gastric bypass
* diabetes
* suffering from a neurodegenerative disorder.
21 Years
60 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Pittsburgh
OTHER
Responsible Party
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David Levinthal
Associate Professor
Principal Investigators
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David J Levinthal, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY23030127
Identifier Type: -
Identifier Source: org_study_id
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