CClinicalTrials.gg
CompletedNCT04612101Updated Nov 2, 2020

Check Brain Temp Trial

An observational study in the Focus of the Clinical Trial is on the Brain Temperatures in Normal Human Subjects, sponsored by OSF Healthcare System. Completed at 1 site in United States. Open to male participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-02.

Sponsored by OSF Healthcare System · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

Despite some controversial results, many patients and animal studies have suggested significant benefit of using hypothermia treatment in stroke patient population. However, certain questions for how to applying this therapy properly such as when to start, what is the optimal temperature, how long is the duration, and what is the best hypothermia technology that may avoid the complications including focal soft tissue injuries are still remain questioned.

In this study, we will utilize the linear relationship of temperature vs. chemical shift in MR Spectroscopy to measure the brain temperatures in normal men.

Read the detailed description

Brain temperature has an interactive relationship with brain cell metabolism. Hypothermia is a known neuronal protectant therapy. It has been proven to be effective in reducing the brain injury in patients post cardiac arrest. However, the role of hypothermia in brain or spinal cord injury such as in either hemorrhagic or ischemic condition remains unclear. Many questions on hypothermia are unanswered. For example, what is the optimal low temperature in order to have the maximum therapeutic effect? How long should hypothermia be applied for? Is there a regional temperature difference between different parts of brain in physiological or pathological conditions? In order to answer these questions, the first step is to have a reliable way of measuring brain temperature accurately. However, invasive technique such as inserting temperature probe to different parts of brain is not practical. Using body core temperature to estimate the intracranial temperature is inaccurate.

To establish a noninvasive means to obtain and monitor brain temperature in a dynamic environment is the essential step in order to studying hypothermia and answering the questions mentioned earlier. MRI brain thermometry is a fast, direct and non-invasive method to estimate the brain temperature with great accuracy. This technique is based on several temperature dependent physical properties in our brain such as chemical shift between metabolites and water. Currently, there is no standard MRI brain thermometry in physiological and pathological conditions such as stroke. We plan to explore and establish MRI brain thermometry. The first step is to establish temperature correlation on measured water temperature.

Then temperature of different regions of brain will be used to compare to the standardized water temperature in normal people.

02

Conditions studied

  • the Focus of the Clinical Trial is on the Brain Temperatures in Normal Human Subjects

Keywords

  • MR Thermometry
  • Human brain temperature
  • MR spectroscopy
  • normal brain
03

In context

Lead sponsor

OSF Healthcare System is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

normal and healthy Men

Inclusion criteria

  • Normal and healthy

Exclusion criteria

Exclusion Criteria:

    1. claustrophobia, 2. history of neurological disease. 3. Tattoo and 4. History of lost conscience due to any head injury.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Brian temperatures

    Brian temperatures were measured at region of interests

    Time frame: Brain temperatures were taken during an hour

07

Study locations

1 site
  • OSF Healthcare Saint Francis Medical Center
    Peoria, Illinois 61637, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04612101
Lead sponsor
OSF Healthcare System
Collaborators
University of Illinois College of Medicine at Peoria
Responsible party
WenChing Liu (Clinical Medical Physicist, OSF Healthcare System) — Principal investigator
First posted
Nov 2, 2020
Start date
Oct 1, 2018
Primary completion
Oct 1, 2020
Completion
Oct 1, 2020
Last update
Nov 2, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion