Stability of Motor Output in Aging Adults

Swallowing Clinical Trial

Official title:

Corticobulbar Motor Output in Aging Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970736
• Other study ID #: C6697-M
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: March 5, 2015
• Start date: November 2009
• Est. completion date: October 2011

Study information

• Verified date: December 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Swallowing

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Motor Map Center of Gravity	Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).	2 weeks	No
Secondary	Area of Submental 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.	2 weeks	No