Healthy VolunteersNCT02050386
The Brain Alerting Mechanism Study
An observational study of Healthy Volunteers, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cold pressor stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults 18 and older.
Who may be able to join
- Ages 18 to 95
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- Cold pressor stimulation, Sham Stimulation
- Keywords
- Brain arousal systems, Aging, MRI, fMRI, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold pressor stimulationOther
Immersion of the foot in 0-2 degrees C water for 50 seconds
Sham StimulationOther
Immersion of the foot in room temperature water for 50 seconds
| Study group | Role | What they receive |
|---|---|---|
| Cold pressor stimulation | Immersion of the foot in 0-2 degrees C water for 50 seconds. Receives: Other: Cold pressor stimulation | |
| Sham Stimulation | Immersion of the foot in room temperature water for 50 seconds. Receives: Other: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
MRI: BOLD Response
Functional MRI
Measured: 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.
Measured: up to 30 days
MRI: BOLD Response
Functional MRI
Measured: up to 30 days
Secondary outcomes (5)
Physiological Response: Mean Heart Rate
Heart Rate
Measured: Baseline
Cognitive Functions: N-Back Task Test
N-Back Score is as follows: the mean is 100 and the standard deviation (SD) is 15.
Measured: Baseline
Cognitive Functions: Attention Tasks Test
Attention tests score is measured using a of mean 100 and the standard deviation (SD) is 15.
Measured: Baseline
Cognitive Functions: Memory Task Test
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.
Measured: Baseline
Physical Function: Short Physical Performance Battery
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Resources were refocused into another project preventing this project from starting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam J Woods, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050386
- Sponsor's protocol ID
- IRB201300392
- Status last verified
- Dec 2016
- First submitted
- 23 Jan 2014
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Brain Arousal Systems in Cognitive and Physical Decline in Normal Aging
- ClinicalTrials.gov ID
- NCT02050386
- Acronym / sponsor ID
- IRB201300392
- Conditions
- Healthy Volunteers
- Keywords
- Brain arousal systems, Aging, MRI, fMRI, Cognition
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Resources were refocused into another project preventing this project from starting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold pressor stimulation | – | Other: Cold pressor stimulationImmersion of the foot in 0-2 degrees C water for 50 seconds. |
| Sham Stimulation | – | Other: Sham StimulationImmersion of the foot in room temperature water for 50 seconds. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults 18 and older.
Key inclusion criteria (1 listed)
- Ages 18 to 95
Key exclusion criteria (9 listed)
- History of pre-existing neurological disorders,
- Psychiatric brain disorders,
- Diagnosis with a neurodegenerative brain disease,
- Uncontrolled blood pressure (>200/110),
- History of severe hypertension,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold pressor stimulationImmersion of the foot in 0-2 degrees C water for 50 seconds | Other | Cold pressor stimulation |
| Sham StimulationImmersion of the foot in room temperature water for 50 seconds | Other | Sham Stimulation |
Primary outcome
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.
MRI: BOLD Response
Time frame: Baseline
Functional MRI
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.
MRI: BOLD Response
Time frame: up to 30 days
Functional MRI
5 secondary outcomes
Physiological Response: Mean Heart Rate
Time frame: Baseline
Cognitive Functions: N-Back Task Test
Time frame: Baseline
Cognitive Functions: Attention Tasks Test
Time frame: Baseline
Cognitive Functions: Memory Task Test
Time frame: Baseline
Physical Function: Short Physical Performance Battery
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam J Woods, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016; AzTrials last refreshed its copy on 29 Oct 2026.