Skip to main content
Clinical Trials/NCT00970736
NCT00970736
Completed
Not Applicable

Corticobulbar Motor Output in Aging Adults

US Department of Veterans Affairs1 site in 1 country20 target enrollmentNovember 2009
ConditionsSwallowing

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Swallowing
Sponsor
US Department of Veterans Affairs
Enrollment
20
Locations
1
Primary Endpoint
Mean Motor Evoked Potential Amplitude for Submental Cortical Representation
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
October 2011
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • Motor Map Center of Gravity(2 weeks)
  • Area of Submental Representation(2 weeks)

Study Sites (1)

Loading locations...

Similar Trials