- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00970736
Stability of Motor Output in Aging Adults
Corticobulbar Motor Output in Aging Adults
연구 개요
상태
정황
상세 설명
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:
- To demonstrate the reproducibility of TMS mapping of the submental muscle group in healthy older adults between 60 and 80 years of age
- 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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Florida
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Gainesville, Florida, 미국, 32608
- North Florida/South Georgia Veterans Health System
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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1
20 healthy participants between 60 and 80 years of age.
Ten men and 10 women.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Motor Evoked Potential Amplitude for Submental Cortical Representation
기간: 2 weeks
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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.
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2 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Motor Map Center of Gravity
기간: 2 weeks
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Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).
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2 weeks
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Area of Submental Representation
기간: 2 weeks
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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.
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2 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Karen Hegland, PhD, North Florida/South Georgia Veterans Health System
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .