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Noninvasive Monitoring of Cerebral Blood Flow Autoregulation in Patients With Traumatic Brain Injury (TBI) (REG01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01605838
Recruitment Status : Withdrawn (A series of administrative delays on all sides involved, combined with funding problems.)
First Posted : May 25, 2012
Last Update Posted : January 14, 2015
University of Southern California
Information provided by (Responsible Party):
Advanced Brain Monitoring, Inc.

Brief Summary:

BACKGROUND: The brain is very sensitive to both excessive and insufficient flow of blood. Cerebral blood flow (CBF) is normally auto-regulated by the blood vessels in the brain, but this protective mechanism is often disturbed after a traumatic brain injury (TBI). Impairment or loss of the CBF autoregulation makes the brain vulnerable to oscillations of either arterial blood pressure (ABP) or intracranial pressure (ICP). The ideal management of TBI patients, therefore, involves continuous measurement and management of the cerebral perfusion pressure (CPP = ABP - ICP) but the measurement of CPP is currently possible only with specialized equipment and expertise that is not available in all institutions. The investigators have converted a no-longer used system that continuously monitors CBF autoregulation using rheoencephalography (REG) technology into a modern, small, battery-powered, low-cost monitor (aka BM-1) that acquires the REG signals using only noninvasive electrodes placed on the skin/scalp. REG data can then be used to calculate the optimal CPP to maintain in each individual patient. BM-1 is also capable of monitoring electroencephalography (EEG) and impedance plethysmography (IPG), which can, respectively, be used to measure brain electrical activity and changes in peripheral blood flow caused by blood pressure changes.

OBJECTIVES: The primary objectives are to (Obj. 1) demonstrate that REG acquired noninvasively is equal to the well-established but invasive method using intracranial pressure (ICP) monitoring, (Obj. 2) retrospectively test the idea that TBI patients have a less favorable outcome if their CPP were found less optimal using the REG data, and (Obj. 3) determine if noninvasive IPG or the PPG finger sensor monitoring (used to measure heart rate in doctor's offices) can replace the invasive monitoring of arterial blood pressure (ABP).

METHODOLOGY: This is an observational study with retrospective data analysis. 20 adult patients (18-65 yrs) with acute TBI, who meet the inclusion/exclusion criteria, will be enrolled on a first-come-first-enroll basis. The enrolled patients will have the REG, EEG and IPG signals monitored for the duration of ICU stay or 15 days, whichever is shorter. Standard neurological assessment will be made at the patient's discharge from the ICU and at 3 months after injury. The study is expected to end June 2013.

Condition or disease
Traumatic Brain Injury (TBI)

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot (Feasibility) Study of New Portable Monitor for Continuous Assessment of Cerebral Blood Flow (CBF) Autoregulation in Patients With Moderate to Severe Traumatic Brain Injury (TBI)
Study Start Date : August 2012
Estimated Primary Completion Date : June 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Extended Glasgow Outcome Scale (GOSE) [ Time Frame: 3 months post-injury ]

Secondary Outcome Measures :
  1. Neurobehavioral Symptom Inventory (NSI) [ Time Frame: 3 months post-injury ]
  2. Rappaport Disability Rating Scale (DSR) [ Time Frame: At discharge from intensive care unit; on average, 10 days post-injury ]
    Note regarding the time frame: based on the USC patient database for 2010 and 2011, patients may be discharged from the ICU anywhere between 4 days to 4 weeks; 50% of them will spend 10 +/- 3 days in the ICU.

  3. Katz Index of Independence in Activities of Daily Living (KI-ADL) [ Time Frame: 3 months post-injury ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (18 - 65 years) hospitalized in the surgical intensive care unit (ICU) because of moderate to severe traumatic brain injury

Inclusion Criteria:

  • Clinical diagnosis of acute moderate or severe TBI
  • Hospitalization within 12 hours from the injury
  • Intraarterial catheterization and intracranial pressure (ICP) monitoring instantiated within 72 hours from the injury

Exclusion Criteria:

  • Earlier head injuries, stroke, space-occupying intracranial lesions, meningitis, or cerebral vasculopathies
  • Concomitant severe injuries of the chest, abdomen, pelvis, extremities or spine
  • Concurrent terminal illness with a life expectancy of less than 6 months
  • Unlikely to survive the next 48 hours after enrollment
  • Implanted cardiac pacemaker, cardiac converter/defibrillator, or other electrical stimulator
  • Pregnancy
  • Patient is a prisoner or on a probation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01605838

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United States, California
LA County + USC Medical Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Advanced Brain Monitoring, Inc.
University of Southern California
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Principal Investigator: Djordje Popovic, MD Advanced Brain Monitoring, Inc.
Bodo M. Studies in rheoencephalography . Journal of Electrical Bioimpedance 2010; 1: 18 - 40.

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Responsible Party: Advanced Brain Monitoring, Inc. Identifier: NCT01605838    
Other Study ID Numbers: ABM-TBI-0001
W81XWH - 10 - C - 0061 ( Other Grant/Funding Number: DOD TATRC )
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
Keywords provided by Advanced Brain Monitoring, Inc.:
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System