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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Advanced Brain Monitoring, Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Advanced Brain Monitoring, Inc.
ClinicalTrials.gov Identifier:
NCT01605838
First received: May 22, 2012
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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
Traumatic Brain Injury (TBI)

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Advanced Brain Monitoring, Inc.:

Primary Outcome Measures:
  • Extended Glasgow Outcome Scale (GOSE) [ Time Frame: 3 months post-injury ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurobehavioral Symptom Inventory (NSI) [ Time Frame: 3 months post-injury ] [ Designated as safety issue: No ]
  • Rappaport Disability Rating Scale (DSR) [ Time Frame: At discharge from intensive care unit; on average, 10 days post-injury ] [ Designated as safety issue: No ]
    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.

  • Katz Index of Independence in Activities of Daily Living (KI-ADL) [ Time Frame: 3 months post-injury ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605838

Contacts
Contact: Kenji Inaba, MD 323 - 409 - 8597 kenji.inaba@med.usc.edu

Locations
United States, California
LA County + USC Medical Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Kenji Inaba, MD    323-409-8050    kenji.inaba@med.usc.edu   
Principal Investigator: Kenji Inaba, MD         
Sub-Investigator: Lydia Lam, MD         
Sponsors and Collaborators
Advanced Brain Monitoring, Inc.
University of Southern California
Investigators
Principal Investigator: Djordje Popovic, MD Advanced Brain Monitoring, Inc.
  More Information

Publications:

Responsible Party: Advanced Brain Monitoring, Inc.
ClinicalTrials.gov Identifier: NCT01605838     History of Changes
Other Study ID Numbers: ABM-TBI-0001, W81XWH - 10 - C - 0061
Study First Received: May 22, 2012
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Advanced Brain Monitoring, Inc.:
TBI

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014