The Brain Alerting Mechanism Study

NCT02050386 | Withdrawn

• 1 other identifier: IRB201300392
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Brain arousal systems; Aging; MRI; fMRI; Cognition

Outcome Measures

Primary Outcomes (4)

• Cognitive Function

  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

  Functional MRI

  Baseline

• Cognitive Function

  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

  Functional MRI

  up to 30 days

Secondary Outcomes (5)

• Physiological Response: Mean Heart Rate

  Baseline

• Cognitive Functions: N-Back Task Test

  Baseline

• Cognitive Functions: Attention Tasks Test

  Baseline

• Cognitive Functions: Memory Task Test

  Baseline

• Physical Function: Short Physical Performance Battery

  Baseline

Study Arms (2)

Cold pressor stimulation

Immersion of the foot in 0-2 degrees C water for 50 seconds.

Other: Cold pressor stimulation

Sham Stimulation

Immersion of the foot in room temperature water for 50 seconds.

Other: Sham Stimulation

Interventions

Cold pressor stimulation OTHER

Immersion of the foot in 0-2 degrees C water for 50 seconds

Cold pressor stimulation

Sham Stimulation OTHER

Immersion of the foot in room temperature water for 50 seconds

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults 18 and older.

You may qualify if:

• Ages 18 to 95

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Study Officials

• Adam J Woods, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 30, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 19, 2016

Record last verified: 2016-12

Locations

US (1)