AzTrials
AzTrials

Traumatic Brain Injury (TBI)REG01NCT01605838

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

An observational study of Traumatic Brain Injury (TBI), run by Advanced Brain Monitoring, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Traumatic Brain Injury (TBI)
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2012to May 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients (18 - 65 years) hospitalized in the surgical intensive care unit (ICU) because of moderate to severe traumatic brain injury

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • LA County + USC Medical Center

    Los Angeles, California, 90033

Other trials in United States

About this study

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)

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.

Keywords
TBI
Medical subject headings
Brain Injuries, Traumatic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extended Glasgow Outcome Scale (GOSE)

    Measured: 3 months post-injury

Secondary outcomes (3)

  1. Neurobehavioral Symptom Inventory (NSI)

    Measured: 3 months post-injury

  2. Rappaport Disability Rating Scale (DSR)

    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.

    Measured: At discharge from intensive care unit; on average, 10 days post-injury

  3. Katz Index of Independence in Activities of Daily Living (KI-ADL)

    Measured: 3 months post-injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJun 2013 (estimated)
  4. Study completionMay 2014

Why it stopped: A series of administrative delays on all sides involved, combined with funding problems.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01605838
Sponsor's protocol ID
ABM-TBI-0001
Other IDs
W81XWH - 10 - C - 0061
Acronym
REG01
Status last verified
Jan 2015
First submitted
22 May 2012
Last updated
14 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Overgaard J, Tweed WA. Cerebral circulation after head injury. 1. Cerebral blood flow and its regulation after closed head injury with emphasis on clinical correlations. J Neurosurg. 1974 Nov;41(5):531-41. doi: 10.3171/jns.1974.41.5.0531. No abstract available.

    PubMed 4418221

  • Czosnyka M, Smielewski P, Kirkpatrick P, Menon DK, Pickard JD. Monitoring of cerebral autoregulation in head-injured patients. Stroke. 1996 Oct;27(10):1829-34. doi: 10.1161/01.str.27.10.1829.

    PubMed 8841340

  • Lam JM, Hsiang JN, Poon WS. Monitoring of autoregulation using laser Doppler flowmetry in patients with head injury. J Neurosurg. 1997 Mar;86(3):438-45. doi: 10.3171/jns.1997.86.3.0438.

    PubMed 9046300

  • Lang EW, Chesnut RM. A bedside method for investigating the integrity and critical thresholds of cerebral pressure autoregulation in severe traumatic brain injury patients. Br J Neurosurg. 2000 Apr;14(2):117-26. doi: 10.1080/02688690050004534.

    PubMed 10889883

  • Steiner LA, Czosnyka M, Piechnik SK, Smielewski P, Chatfield D, Menon DK, Pickard JD. Continuous monitoring of cerebrovascular pressure reactivity allows determination of optimal cerebral perfusion pressure in patients with traumatic brain injury. Crit Care Med. 2002 Apr;30(4):733-8. doi: 10.1097/00003246-200204000-00002.

    PubMed 11940737

  • Lang EW, Mehdorn HM, Dorsch NW, Czosnyka M. Continuous monitoring of cerebrovascular autoregulation: a validation study. J Neurol Neurosurg Psychiatry. 2002 May;72(5):583-6. doi: 10.1136/jnnp.72.5.583.

    PubMed 11971041

  • Schmidt B, Czosnyka M, Raabe A, Yahya H, Schwarze JJ, Sackerer D, Sander D, Klingelhofer J. Adaptive noninvasive assessment of intracranial pressure and cerebral autoregulation. Stroke. 2003 Jan;34(1):84-9. doi: 10.1161/01.str.0000047849.01376.ae.

    PubMed 12511755

  • Brady KM, Shaffner DH, Lee JK, Easley RB, Smielewski P, Czosnyka M, Jallo GI, Guerguerian AM. Continuous monitoring of cerebrovascular pressure reactivity after traumatic brain injury in children. Pediatrics. 2009 Dec;124(6):e1205-12. doi: 10.1542/peds.2009-0550.

    PubMed 19948619

  • Bodo M. Studies in rheoencephalography . Journal of Electrical Bioimpedance 2010; 1: 18 - 40.

  • Bodo M, Pearce FJ, Montgomery LD, Rosenthal M, Kubinyi G, Thuroczy G, Braisted J, Forcino D, Morrissette C, Nagy I. Measurement of brain electrical impedance: animal studies in rheoencephalography. Aviat Space Environ Med. 2003 May;74(5):506-11.

    PubMed 12751577

  • Bodo M, Pearce FJ, Baranyi L, Armonda RA. Changes in the intracranial rheoencephalogram at lower limit of cerebral blood flow autoregulation. Physiol Meas. 2005 Apr;26(2):S1-17. doi: 10.1088/0967-3334/26/2/001. Epub 2005 Mar 29.

    PubMed 15798222

  • Bodo M, Pearce FJ, Armonda RA. Cerebrovascular reactivity: rat studies in rheoencephalography. Physiol Meas. 2004 Dec;25(6):1371-84. doi: 10.1088/0967-3334/25/6/003.

    PubMed 15712716

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury (TBI), run by Advanced Brain Monitoring, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extended Glasgow Outcome Scale (GOSE) (time frame: 3 months post-injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01605838, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in