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

Traumatic Brain Injury (TBI) Clinical Trial

— REG01  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01605838
• Other study ID #: ABM-TBI-0001
• Secondary ID: W81XWH - 10 - C
• Status: Withdrawn
• Phase: N/A
• First received: May 22, 2012
• Last updated: January 12, 2015
• Start date: August 2012
• Est. completion date: May 2014

Study information

• Verified date: January 2015
• Source: Advanced Brain Monitoring, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury (TBI)

Locations

Country	Name	City	State
United States	LA County + USC Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Brain Monitoring, Inc.	University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (12)

Bodo M, Pearce FJ, Armonda RA. Cerebrovascular reactivity: rat studies in rheoencephalography. Physiol Meas. 2004 Dec;25(6):1371-84. — View Citation

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. Epub 2005 Mar 29. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Schmidt B, Czosnyka M, Raabe A, Yahya H, Schwarze JJ, Sackerer D, Sander D, Klingelhöfer J. Adaptive noninvasive assessment of intracranial pressure and cerebral autoregulation. Stroke. 2003 Jan;34(1):84-9. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extended Glasgow Outcome Scale (GOSE)		3 months post-injury	No
Secondary	Neurobehavioral Symptom Inventory (NSI)		3 months post-injury	No
Secondary	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.	At discharge from intensive care unit; on average, 10 days post-injury	No
Secondary	Katz Index of Independence in Activities of Daily Living (KI-ADL)		3 months post-injury	No