- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00970736
Stability of Motor Output in Aging Adults
Corticobulbar Motor Output in Aging Adults
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Florida
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Gainesville, Florida, Förenta staterna, 32608
- North Florida/South Georgia Veterans Health System
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
1
20 healthy participants between 60 and 80 years of age.
Ten men and 10 women.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Motor Evoked Potential Amplitude for Submental Cortical Representation
Tidsram: 2 weeks
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Motor Map Center of Gravity
Tidsram: 2 weeks
|
Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).
|
2 weeks
|
|
Area of Submental Representation
Tidsram: 2 weeks
|
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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Karen Hegland, PhD, North Florida/South Georgia Veterans Health System
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- C6697-M
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