Clinical trial NCT00970736: Stability of Motor Output in Aging Adults
Official title: Corticobulbar Motor Output in Aging Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Swallowing
Keywords: Motor cortex
Motor control
Neuroplasticity
Aging
Swallowing
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults between 60 and 80 years of age

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Motor Evoked Potential Amplitude for Submental Cortical Representation
timeFrame: 2 weeks
Secondary outcomes:
measure: Motor Map Center of Gravity
timeFrame: 2 weeks
measure: Area of Submental Representation
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: Karen Hegland, PhD
role: PRINCIPAL_INVESTIGATOR
References: