Stability of Motor Output in Aging Adults

NCT ID: NCT00970736

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-10-31

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.

Conditions

Swallowing

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

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

No interventions assigned to this group

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Hegland, PhD

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System

Locations

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Countries

United States

Other Identifiers

C6697-M

Identifier Type: -

Identifier Source: org_study_id