Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04612101 |
| Other study ID # |
1140816 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
October 1, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
OSF Healthcare System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
