Stability of Motor Output in Aging Adults

NCT00970736 | Completed Results

• 1 other identifier: C6697-M
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Swallowing

Keywords

Motor cortex; Motor control; Neuroplasticity; Aging; Swallowing

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (2)

• Motor Map Center of Gravity

  2 weeks

• Area of Submental Representation

  2 weeks

Study Arms (1)

1

20 healthy participants between 60 and 80 years of age. Ten men and 10 women.

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults between 60 and 80 years of age

You may qualify if:

• Between 60 and 80 years of age

You may not qualify if:

• 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)

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Results Point of Contact

• Title: Karen Hegland
• Organization: University of Florida

kwheeler@ufl.edu

352 359-1830

Study Officials

• Karen Hegland, PhD

  North Florida/South Georgia Veterans Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 8, 2015
• Results First Posted: April 8, 2015

Record last verified: 2014-12

Locations

US (1)