Stability of Motor Output in Aging Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00970736
First received: September 1, 2009
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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.


Condition
Swallowing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Corticobulbar Motor Output in Aging Adults

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Mean motor evoked potential amplitude for submental cortical representation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor map center of gravity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Area of submental representation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
20 healthy participants between 60 and 80 years of age. Ten men and 10 women.

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

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy adults between 60 and 80 years of age

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00970736

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Investigators
Principal Investigator: Karen Hegland, PhD North Florida/South Georgia Veterans Health System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00970736     History of Changes
Other Study ID Numbers: C6697M
Study First Received: September 1, 2009
Last Updated: December 2, 2011
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Motor cortex
Motor control
Neuroplasticity
Aging
Swallowing

ClinicalTrials.gov processed this record on September 18, 2014