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The Brain Alerting Mechanism Study

16 de diciembre de 2016 actualizado por: University of Florida

The Role of Brain Arousal Systems in Cognitive and Physical Decline in Normal Aging

This is a study designed to look at how arousal levels in the brain change with age and how these changes influence thinking, vision, hearing and physical function in people of advanced age.

Descripción general del estudio

Estado

Retirado

Descripción detallada

There are two parts involved in this study:

Part #1- Paperwork, Computer-based cognitive tests, Physical function test, EEG recording

  • Potential participants will be pre-screened at the time of their initial phone call to be sure they fit the guidelines for this research study.
  • Participants will be given this Informed Consent document. This Informed Consent will be reviewed in a private location; participants will be given as much time as participants need to consider enrolling in the study. Participants may want to discuss the information with friends or family. Participants may ask questions at any time during the study visit.
  • If participants choose to sign this form, and agree to participate, participants will be further screened for inclusion/exclusion factors related to the MRI scanning. All women under the age of 62 will be given a pregnancy test, based on a urine sample.
  • Investigators will review a detailed Medical History form with participants, asking questions about participants and participants family's medical history.
  • Investigators will ask participants to complete a brief physical activity questionnaire asking questions about participants daily level of physical activity.
  • Participants will be asked to complete several computer tasks meant to measure participants cognitive abilities (like memory and attention), which takes about 30 minutes.
  • Participants will also be asked to complete a short physical performance battery (SPPB), that looks at participants ability to sit and stand, walk a short distance, and balance, which takes about 30 minutes.
  • Participants will also be asked to participate in an EEG recording session. An EEG cap, selected for participants head size, will be placed on participants head. The cap contains small electrodes that record participants brains electrical activity. During this part of the study, participants will sit in a comfortable chair while watching pictures on a computer screen, listening to sounds through headphones, or resting. This will take about 1 hour.
  • Participants will also be asked to undergo a cold pressor test (CPT) and/or sham stimulation. CPT involves immersing either participants hand or foot in cold water for about one minute. Sham stimulation involved immersing either the hand or foot in room temperature water for about one minute.
  • Finally, participants will be transported by someone involved with this study (by passenger van or golf cart) to the McKnight Brain Institute MRI Center. Or, if participants prefer, the next portion of the visit can be scheduled for another day.

Part #2- MRI Scan

The following procedures will take place at the Advanced Magnetic Resonance Imaging Center at the McKnight Brain Institute- for the MRI brain scan, and can be done on the same day as Part #1, or on a different day for participants scheduling convenience.

Magnetic resonance imaging (MRI) is a procedure that allows doctors to look inside the body by using a scanner that sends out a strong magnetic field and radio waves. This procedure is used routinely for medical care and is very safe for most people, but participants will be monitored during the entire MRI scan in case any problems occur. The risks of MRI are:

  • The MRI scanner contains a very strong magnet. Therefore, participants may not be able to have the MRI if participants have any type of metal implanted in participants body, for example, any pacing device (such as a heart pacer), any metal in participants eyes, or certain types of heart valves or brain aneurysm clips. Someone will ask participants questions about this before participants have the MRI.
  • There is not much room inside the MRI scanner. Participants may be uncomfortable if participants do not like to be in close spaces ("claustrophobia"). During the procedure, participants will be able to talk with the MRI staff through a speaker system, and, in the event of an emergency, participants can tell them to stop the scan.
  • The MRI scanner produces a loud hammering noise, which has produced hearing loss in a very small number of patients. Participants will be given earplugs to reduce this risk.

Tipo de estudio

De observación

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • University of Florida

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 95 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Healthy adults 18 and older.

Descripción

Inclusion Criteria:

  • Ages 18 to 95

Exclusion Criteria:

  • History of pre-existing neurological disorders,
  • Psychiatric brain disorders,
  • Diagnosis with a neurodegenerative brain disease,
  • Uncontrolled blood pressure (>200/110),
  • History of severe hypertension,
  • History of angina
  • People who have metal implants and can not have an MRI scan,
  • People who are claustrophobic,
  • Females of child-bearing age and have a positive test for pregnancy

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Cold pressor stimulation
Immersion of the foot in 0-2 degrees C water for 50 seconds.
Immersion of the foot in 0-2 degrees C water for 50 seconds
Sham Stimulation
Immersion of the foot in room temperature water for 50 seconds.
Immersion of the foot in room temperature water for 50 seconds

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cognitive Function
Periodo de tiempo: Baseline

The Cognition Domain measures several aspects of cognitive functioning for ages 3-85, including language, episodic memory, executive function, working memory and processing speed.

To interpret individual performance, one can evaluate all three types of scale scores. A participant's age-adjusted scale score at or near 100 indicates vocabulary ability that is average for the age level. Scores around 115 suggest above-average vocabulary ability, while scores around 130 suggest superior ability.

Baseline
MRI: BOLD Response
Periodo de tiempo: Baseline
Functional MRI
Baseline
Cognitive Function
Periodo de tiempo: up to 30 days

The Cognition Domain measures several aspects of cognitive functioning for ages 3-85, including language, episodic memory, executive function, working memory and processing speed.

To interpret individual performance, one can evaluate all three types of scale scores. A participant's age-adjusted scale score at or near 100 indicates vocabulary ability that is average for the age level. Scores around 115 suggest above-average vocabulary ability, while scores around 130 suggest superior ability.

up to 30 days
MRI: BOLD Response
Periodo de tiempo: up to 30 days
Functional MRI
up to 30 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Physiological Response: Mean Heart Rate
Periodo de tiempo: Baseline
Heart Rate
Baseline
Cognitive Functions: N-Back Task Test
Periodo de tiempo: Baseline
N-Back Score is as follows: the mean is 100 and the standard deviation (SD) is 15.
Baseline
Cognitive Functions: Attention Tasks Test
Periodo de tiempo: Baseline
Attention tests score is measured using a of mean 100 and the standard deviation (SD) is 15.
Baseline
Cognitive Functions: Memory Task Test
Periodo de tiempo: Baseline
The memory tests scoring for ease of understanding, corresponds to an Age-Adjusted Scale Score of 115 - exactly 1 SD above the mean of 100.
Baseline
Physical Function: Short Physical Performance Battery
Periodo de tiempo: Baseline
Short battery of tests that include walking and standing. The score includes the distance to range from 400m to 700m. A lower score indicates worse function.
Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Adam J Woods, PhD, University of Florida

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 2013

Finalización primaria (Actual)

1 de junio de 2015

Finalización del estudio (Actual)

1 de junio de 2015

Fechas de registro del estudio

Enviado por primera vez

23 de enero de 2014

Primero enviado que cumplió con los criterios de control de calidad

28 de enero de 2014

Publicado por primera vez (Estimar)

30 de enero de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

19 de diciembre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

16 de diciembre de 2016

Última verificación

1 de diciembre de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB201300392

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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