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The Brain Alerting Mechanism Study

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ClinicalTrials.gov Identifier: NCT02050386
Recruitment Status : Withdrawn (Resources were refocused into another project preventing this project from starting)
First Posted : January 30, 2014
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment
Healthy Volunteers Other: Cold pressor stimulation Other: Sham Stimulation

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Role of Brain Arousal Systems in Cognitive and Physical Decline in Normal Aging
Study Start Date : November 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Group/Cohort Intervention/treatment
Cold pressor stimulation
Immersion of the foot in 0-2 degrees C water for 50 seconds.
Other: Cold pressor stimulation
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.
Other: Sham Stimulation
Immersion of the foot in room temperature water for 50 seconds




Primary Outcome Measures :
  1. Cognitive Function [ Time Frame: 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.


  2. MRI: BOLD Response [ Time Frame: Baseline ]
    Functional MRI

  3. Cognitive Function [ Time Frame: 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.


  4. MRI: BOLD Response [ Time Frame: up to 30 days ]
    Functional MRI


Secondary Outcome Measures :
  1. Physiological Response: Mean Heart Rate [ Time Frame: Baseline ]
    Heart Rate

  2. Cognitive Functions: N-Back Task Test [ Time Frame: Baseline ]
    N-Back Score is as follows: the mean is 100 and the standard deviation (SD) is 15.

  3. Cognitive Functions: Attention Tasks Test [ Time Frame: Baseline ]
    Attention tests score is measured using a of mean 100 and the standard deviation (SD) is 15.

  4. Cognitive Functions: Memory Task Test [ Time Frame: 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.

  5. Physical Function: Short Physical Performance Battery [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults 18 and older.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050386


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Adam J Woods, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02050386     History of Changes
Other Study ID Numbers: IRB201300392
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016

Keywords provided by University of Florida:
Brain arousal systems
Aging
MRI
fMRI
Cognition