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Stability of Motor Output in Aging Adults

Corticobulbar Motor Output in Aging Adults

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00970736
Enrollment
20
Registered
2009-09-02
Start date
2009-11-30
Completion date
2011-10-31
Last updated
2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Swallowing

Keywords

Motor cortex, Motor control, Neuroplasticity, Aging, Swallowing

Brief summary

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.

Detailed description

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: 1. To demonstrate the reproducibility of TMS mapping of the submental muscle group in healthy older adults between 60 and 80 years of age 2. To determine the neural representation of submental musculature in the motor cortex of healthy older adults between 60 and 80 years of age. 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.

Interventions

None listed

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Between 60 and 80 years of age

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: * Metallic hardware on the scalp in the area where TMS will be applied * Cardiac pacemaker * Implanted medication pumps or an intracardiac line * Prior diagnosis of seizure or epilepsy in the subject (childhood history of benign febrile seizure will not be a contraindication) * Poorly controlled migraine headaches * Previous brain neurosurgery * Medications that can lower seizure threshold (Appendix B) * Unstable medical conditions * Lowest motor thresholds above 80% on TMS

Design outcomes

Primary

MeasureTime frameDescription
Mean Motor Evoked Potential Amplitude for Submental Cortical Representation2 weeksCortical 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.

Secondary

MeasureTime frameDescription
Motor Map Center of Gravity2 weeksPosition on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).
Area of Submental Representation2 weeksCortical 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Healthy Participants
20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
20
Total20

Baseline characteristics

CharacteristicHealthy Participants
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
16 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
Age, Continuous68 years
STANDARD_DEVIATION 6
Region of Enrollment
United States
20 participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 20

Outcome results

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.

Time frame: 2 weeks

Population: This data was not analyzed because the study funding, as well as PIs VA affiliation, ended prior to any data analyses.

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.

Time frame: 2 weeks

Population: This data was not analyzed because the study, funding, and PIs VA affiliation ended prior to any data analyses.

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).

Time frame: 2 weeks

Population: This data was not analyzed because the study and funding, as well as the PIs VA affiliation, ended prior to doing any analyses.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026