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The goal of this project is to examine the area of the brain that controls muscle movement for a group of muscles important for swallowing, and to see how that area changes over 2 weeks of time.
A large number of our nation's veterans develop dysphagia due to the myriad of potential etiological sources of swallowing disorders, including stroke and head and neck cancer. The Veteran's Health Administration has recently identified dysphagia as a major clinical focus for the VA system (Sullivan & Dennis, 2006). In order to accurately assess adaptations in motor cortex, it is first necessary to have a reliable tool for measuring organizational representation in the motor cortex. Transcranial magnetic stimulation (TMS) is a desirable choice for such measurement because of the ability to identify causative relationships between an area of motor cortex stimulated and muscle response. Therefore, the specific research objectives of this proposal are:
Twenty healthy adults, 10 men and 10 women, between the ages of 60 and 80 years will serve as research participants. TMS will be used to establish motor maps of the submental muscles. Subjects will undergo two testing sessions, on day 1 and day 14. The results from each session will be compared to assess excitability and representation within the motor cortex, and to assess stability and reliability of measurement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | 20 healthy participants between 60 and 80 years of age. Ten men and 10 women. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Motor Evoked Potential Amplitude for Submental Cortical Representation | Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation. The mean sEMG amplitudes of the submental muscles for each of these sites is then calculated for the mean MEP measure. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Map Center of Gravity | Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles). | 2 weeks |
| Area of Submental Representation |
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Inclusion Criteria:
Exclusion Criteria:
History of dysphagia
History of neurologic disease
History of head or neck cancer
History of stroke
Untreated hypertension
History of a heart condition or heart disease
Currently pregnant
Contraindication to TMS including:
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Healthy adults between 60 and 80 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Karen Hegland, PhD | North Florida/South Georgia Veterans Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System | Gainesville | Florida | 32608 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants | 20 healthy participants between 60 and 80 years of age. Ten men and 10 women. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Healthy adults between the ages of 60 and 80 years
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Participants | 20 healthy participants between 60 and 80 years of age. Ten men and 10 women. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Motor Evoked Potential Amplitude for Submental Cortical Representation | Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation. The mean sEMG amplitudes of the submental muscles for each of these sites is then calculated for the mean MEP measure. | This data was not analyzed because the study funding, as well as PIs VA affiliation, ended prior to any data analyses. | Posted | 2 weeks |
|
2 weeks (time including the day 1 testing, day 2 testing, and time in between).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Participants | 20 healthy participants between 60 and 80 years of age. Ten men and 10 women. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Hegland | University of Florida | 352 359-1830 | kwheeler@ufl.edu |
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Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation.
| 2 weeks |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Motor Map Center of Gravity | Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles). | This data was not analyzed because the study and funding, as well as the PIs VA affiliation, ended prior to doing any analyses. | Posted | 2 weeks |
|
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| Secondary | Area of Submental Representation | Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation. | This data was not analyzed because the study, funding, and PIs VA affiliation ended prior to any data analyses. | Posted | 2 weeks |
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| 0 |
| 20 |
| 0 |
| 0 |
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