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

January 12, 2015 updated by: Advanced Brain Monitoring, Inc.

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)

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • LA County + USC Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Extended Glasgow Outcome Scale (GOSE)
Time Frame: 3 months post-injury
3 months post-injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurobehavioral Symptom Inventory (NSI)
Time Frame: 3 months post-injury
3 months post-injury
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.
At discharge from intensive care unit; on average, 10 days post-injury
Katz Index of Independence in Activities of Daily Living (KI-ADL)
Time Frame: 3 months post-injury
3 months post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Brain Monitoring, Inc.

Collaborators

University of Southern California

Investigators

  • Principal Investigator: Djordje Popovic, MD, Advanced Brain Monitoring, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABM-TBI-0001
  • W81XWH - 10 - C - 0061 (Other Grant/Funding Number: DOD TATRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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