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| ID | Type | Description | Link |
|---|---|---|---|
| R21NS123502 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This is an exploratory study that will determine and standardize how best to record gastric evoked potentials (GEPs) elicited by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS), by optimizing the TMS parameters and cortical sites necessary to evoke GEPs.
The overall goal of this exploratory study is to determine the optimal conditions to elicit gastric evoked potentials (GEPs) with Transcranial Magnetic Stimulation (TMS).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | All participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation, TMS | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GEP hotspot location | Stimulation location evoking the largest GEP response, relative to FDI hotspot location | Multiple study sessions spanning up to 12 months |
| Change in optimal stimulation parameters at GEP hotspot | Stimulation pattern (single pulses or brief bursts) and strength relative to MT for FDI | Multiple study sessions spanning up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of satiety | Change in GEP amplitude after water load test | Multiple study sessions spanning up to 12 months |
| Effect of neuromodulation | Change in GEP amplitude when water load test is preceded by rTMS |
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Inclusion Criteria:
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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 |
There is no current plan to place participant data into a open-access, shared data repository. However, a data sharing agreement can be made if requested.
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Multiple study sessions spanning up to 12 months |