Trial Outcomes & Findings for Non-invasive Clinical Imaging of Cerebral Metabolism Following Brain Injury Using 13C Magnetic Resonance Spectroscopy. (NCT NCT02745210)

Results Overview

Direct detection, localized in vivo 13C MRS will be used to measure the 13C enrichment of glutamate and glutamine following an infusion of 30% isotopically enriched \[1-13C\] glucose and \[1, 2-13C2\] acetate.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

5 years

Results posted on

2020-12-31

Participant Flow

Participants were recruited from medical, surgical, or neurological services of LLUMC. Non-injured participants were recruited from MRI staff, Loma Linda University student or Resident populations

Participant milestones

Participant milestones
Measure	Traumatic Brain Injury Participants with TBI undergoing 13C Magnetic resonance (MR) spectroscopy.	Control control (non-injured) participants undergoing 13C Magnetic resonance (MR) spectroscopy.
Overall Study STARTED	0	9
Overall Study COMPLETED	0	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Traumatic Brain Injury Participants with TBI undergoing 13C Magnetic resonance (MR) spectroscopy.	Control n=9 Participants control (non-injured) participants undergoing 13C Magnetic resonance (MR) spectroscopy.	Total n=9 Participants Total of all reporting groups
Age, Continuous	—	33 years STANDARD_DEVIATION 7.71 • n=9 Participants	33 years STANDARD_DEVIATION 7.71 • n=9 Participants
Sex: Female, Male Female	0 Participants	5 Participants n=9 Participants	5 Participants n=9 Participants
Sex: Female, Male Male	0 Participants	4 Participants n=9 Participants	4 Participants n=9 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	—	9 participants n=9 Participants	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 5 years

Population: We were not successful in out attempt to collect localized in vivo 13C MRS thus there were no metabolite enrichments to measure and include in the measure data table.

Direct detection, localized in vivo 13C MRS will be used to measure the 13C enrichment of glutamate and glutamine following an infusion of 30% isotopically enriched \[1-13C\] glucose and \[1, 2-13C2\] acetate.

Outcome measures

Outcome data not reported

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brenda Bartnik Olson

Loma LInda University Medical Center

Phone: 1-909-558-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place