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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK144729 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects and CNVS subjects | Experimental | Subjects without gastric problems and subjects with Chronic Nausea and Vomiting (CNVS) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation, TMS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| GMEP location | Location of GMEP hotspot(s) in M1 and/or premotor areas relative to FDI hotspot | Baseline session |
| EGG power change | 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 | Each study session through study completion, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| GMEP amplitude | Amplitude of GMEPs at hotspot | Each study session through study completion, up to 1 year |
| Volume | Volume consumed during the gastric filling task |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul HM Kullmann, PhD | Contact | 412-647-1533 | phmk@pitt.edu | |
| David J Levinthal, MD PhD | Contact | 412-303-0525 | levinthald@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| David J Levinthal, MD PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
Final analytic de-identified datasets will be deposited in the SPARC data repository.
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Datasets will be deposited within 2 years of study completion for as long as the SPARC repository is active.
The SPARC repository is publicly accessible.
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Each study session through study completion, up to 1 year |
| Nausea severity (only participants suffering from chronic nausea) | Nausea severity rating on an 11-point (0-10) Likert-scale (0=none, 10=worst possible) | Each study session through study completion, up to 1 year |