NCT04612101

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

October 27, 2020

Last Update Submit

October 27, 2020

Conditions

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

Keywords

MR ThermometryHuman brain temperatureMR spectroscopynormal brain

Outcome Measures

Primary Outcomes (1)

  • Brian temperatures

    Brian temperatures were measured at region of interests

    Brain temperatures were taken during an hour

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

normal and healthy Men

You may qualify if:

  • Normal and healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OSF Healthcare Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Medical Physicist

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 2, 2020

Study Start

October 1, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations

US(1)