Spreading Depolarizations in Traumatic Brain Injury

NCT03379220 | Completed

• 1 other identifier: Hartings SD-II
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Subdural ECoG (Group 1)

For patients who require craniotomy to treat TBI, a subdural electrode strip will be placed intraoperatively following evacuation of a hematoma or contusion, as required. Electrode strips will be used for subsequent electrocorticography (ECoG) during intensive care. Patients will also undergo continuous scalp EEG monitoring.

Burr Hole ECoG (Group 2)

For patients who do not require surgery but do require invasive monitoring, an intraparenchymal ECoG electrode array will be placed through a cranial burr hole. Depending on other monitoring needs, the location of injuries, and other clinical considerations, the burr hole may be the same as used for placement of other probes or may be separate. In cases of focal injury, the burr hole will be placed to allow electrode targeting to a lobe with significant primary lesion(s). Patients will also undergo continuous scalp EEG monitoring.

EEG (Groups 1-3)

Continuous EEG recordings will be made using Ag/AgCl electrodes placed on or beneath the scalp (subdermal wire) according to standard practice. The default montage will employ eight lead electrodes for each hemisphere following the 10/20 system (Right: Fp2, F4, C4, P4, O2, F8, T4, T6; left: Fp1, F3, C3, P3, O1, F7, T3, T5). Other montages with more dense placement of electrodes in the region of ECoG monitoring may also be used.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 189 patients admitted to intensive care for treatment of TBI will be enrolled. The study will be conducted as an addition to TRACK-TBI (Transforming Research and Clinical Knowledge in Traumatic Brain Injury), an observational study conducted at 11 sites in the United States. The present study will be implemented at 7 of the 11 sites: University of Cincinnati, University of Pennsylvania, University of Pittsburgh, University of Miami, Massachusetts General Hospital, University of California San Francisco, and Baylor College of Medicine.

You may qualify if:

• Enrollment in TRACK-TBI CA cohort
• Admission to intensive care
• Documented TBI \<24 hr before anticipated placement of electrodes
• Lobe of primary injury accessible for ECoG by burr hole or craniotomy access
• Age ≥ 18 years
• Acute brain CT for clinical care
• Visual acuity/hearing adequate for testing
• Fluency in English or Spanish
• Ability to obtain informed consent

You may not qualify if:

• Significant polytrauma that would confound outcome assessment
• Prisoners or patients in custody
• Pregnancy
• Patients on psychiatric hold
• Major debilitating baseline mental health disorder that would interfere with follow-up and the validity of outcome
• Major debilitating neurological disease impairing baseline awareness, cognition, or validity of follow-up and outcome assessment
• Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment
• Low likelihood of follow-up
• Current participation in an interventional trial
• Penetrating TBI
• Spinal cord injury with ASIA score of C or worse
• Bilateral unreactive pupils or other evidence of unsurvivable injury
• Evidence of coagulopathy (INR\>1.5 or thrombocytopenia) or infection, which contraindicate invasive monitoring

Sponsors & Collaborators

• University of Cincinnati: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (7)

University of California San Francisco

San Francisco, California, 94110, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: March 28, 2017
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2022
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (7)