Check Brain Temp Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Normal and healthy

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

WenChing Liu

Clinical Medical Physicist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

OSF Healthcare Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1140816

Identifier Type: -

Identifier Source: org_study_id