Spreading Depolarizations in Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Development and Validation of Spreading Depolarization Monitoring for TBI Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03379220
• Other study ID #: Hartings SD-II
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2017
• Last updated: December 19, 2017
• Start date: March 28, 2017
• Est. completion date: July 14, 2020

Study information

• Verified date: December 2017
• Source: University of Cincinnati
• Contact: Jed Hartings, PhD
• Phone: 5135583567
• Email: Jed.Hartings[@]uc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research aims to extend the application of spreading depolarization monitoring to non-surgical TBI patients, using intraparenchymal electrode arrays and scalp electroencephalography to detect depolarizations and develop less invasive monitoring methods.

Description:

This study aims to develop the new clinical science of spreading depolarizations for routine monitoring of all TBI patients requiring intensive care. This will be accomplished by investigating automated and non-invasive methods for bedside detection of spreading depolarizations and by determining the prognostic value of such monitoring across the spectrum of TBI severity. While current monitoring of depolarizations is invasive and limited to the subgroup of TBI patients requiring craniotomy, pilot studies have shown that spreading depolarizations are also manifested in non-invasive scalp electroencephalographic (EEG) recordings. Here, approximately 189 subjects will undergo neuromonitoring with EEG only (n=63), with combined EEG and intraparenchymal ECoG (n=63), or with combined EEG and subdural ECoG (n=63). Simultaneous ECoG and EEG monitoring will allow characterization of the EEG signatures of spreading depolarizations and enable identification of signal-processing steps and quantitative criteria for their detection with clinically meaningful sensitivity and specificity, as validated against the gold standard of invasive ECoG. In parallel, an observational electrophysiology study of all TBI patients admitted to intensive care, including non-surgical cases, will characterize the incidence of spreading depolarizations across the TBI severity spectrum. Successful completion of these objectives will 1) determine the extent to which findings obtained in surgical TBI patients also generalize to patients who are managed medically, and 2) establish the first non-invasive method for routine bedside monitoring of a neuronal pathomechanism with proven relevance to TBI outcome. In doing so, this study may enable an individualized approach to TBI management and clinical trials in which neuroprotective therapies can be administered selectively to patients based on real-time identification of a marker and mechanism of secondary neuronal injury.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: July 14, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Enrollment in TRACK-TBI CA cohort

2. Admission to intensive care

3. Documented TBI <24 hr before anticipated placement of electrodes

4. Lobe of primary injury accessible for ECoG by burr hole or craniotomy access

5. Age = 18 years

6. Acute brain CT for clinical care

7. Visual acuity/hearing adequate for testing

8. Fluency in English or Spanish

9. Ability to obtain informed consent

Exclusion Criteria:

1. Significant polytrauma that would confound outcome assessment

2. Prisoners or patients in custody

3. Pregnancy

4. Patients on psychiatric hold

5. Major debilitating baseline mental health disorder that would interfere with follow-up and the validity of outcome

6. Major debilitating neurological disease impairing baseline awareness, cognition, or validity of follow-up and outcome assessment

7. Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment

8. Low likelihood of follow-up

9. Current participation in an interventional trial

10. Penetrating TBI

11. Spinal cord injury with ASIA score of C or worse

12. Bilateral unreactive pupils or other evidence of unsurvivable injury

13. Evidence of coagulopathy (INR>1.5 or thrombocytopenia) or infection, which contraindicate invasive monitoring

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Cincinnati	Cincinnati	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	University of Miami	Miami	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale Extended (GOS-E)	Glasgow Outcome Scale- Extended (GOS-E) is an ordinal global scale for functional outcome that rates patient status into one of eight categories, with higher scores representing better recovery: Dead (1), Vegetative State (2), Lower Severe Disability (3), Upper Severe Disability (4), Lower Moderate Disability (5), Upper Moderate Disability (6), Lower Good Recovery (7), and Upper Good Recovery (8).	6 months following injury