An observational study in Swallowing, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-08.
Sponsored by US Department of Veterans Affairs · Observational
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.
US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy adults between 60 and 80 years of age
Exclusion Criteria:
Contraindication to TMS including:
20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
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.
Time frame: 2 weeks
Motor Map Center of Gravity
Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).
Time frame: 2 weeks
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.
Time frame: 2 weeks
| Milestone | Healthy Participants |
|---|---|
| Started | 20 |
| Completed | 18 |
| Not completed | 2 |
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.
No measurements were reported for this outcome.
Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 2 weeks (time including the day 1 testing, day 2 testing, and time in between).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Participants | — | 0/20 (0%) | — |
Healthy adults between the ages of 60 and 80 years
| Age, Categorical(Participants) | Healthy Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 16 |
| Age, Continuous(years) | Healthy Participants |
|---|---|
| Mean | 68 ± 6 |
| Sex: Female, Male(Participants) | Healthy Participants |
|---|---|
| Female | 10 |
| Male | 10 |
| Region of Enrollment(participants) | Healthy Participants |
|---|---|
| United States | 20 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs