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Completed

NCT Number: NCT00970736

Stability of Motor Output in Aging Adults

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.

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Key information

Conditions

Swallowing

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

About this study

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:

  • To demonstrate the reproducibility of TMS mapping of the submental muscle group in healthy older adults between 60 and 80 years of age
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mean Motor Evoked Potential Amplitude for Submental Cortical Representation

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Motor Map Center of Gravity

    Time frame: 2 weeks

    Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).

  2. Area of Submental Representation

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Corticobulbar Motor Output in Aging Adults

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 2, 2009
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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