- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00970736
Stability of Motor Output in Aging Adults
Corticobulbar Motor Output in Aging Adults
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Florida
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Gainesville, Florida, États-Unis, 32608
- North Florida/South Georgia Veterans Health System
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
1
20 healthy participants between 60 and 80 years of age.
Ten men and 10 women.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Motor Evoked Potential Amplitude for Submental Cortical Representation
Délai: 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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Motor Map Center of Gravity
Délai: 2 weeks
|
Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).
|
2 weeks
|
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Area of Submental Representation
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Karen Hegland, PhD, North Florida/South Georgia Veterans Health System
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- C6697-M
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