Intracranial Pressure IncreaseNCT05170295
Noninvasive Monitoring of Cerebral Blood Flow Autoregulation
An observational study of Intracranial Pressure Increase and Cerebral Edema, run by Ochsner Health System at 1 site in United States.
Trial summary
Rheoencephalography (REG) shows promise as a method for noninvasive neuromonitoring, because it reflects cerebrovascular reactivity. This protocol will study clinical and technical conditions required to use REG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure Increase, Cerebral Edema
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2018to 28 Apr 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve patients of Neurocritical Care Department with clinical suspicion of elevated intracranial pressure.
Who may be able to join
- Intact fronto-temporal area
- Intact lower arm area
- Clinical suspicion of elevated intracranial pressure
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Rheoencephalography (REG) shows promise as a method for noninvasive neuromonitoring, because it reflects cerebrovascular reactivity. This protocol will study clinical and technical conditions required to use REG. Additionally, our goal is to study noninvasive peripheral bioimpedance pulse waveforms in order to substitute invasive SAP. A previous study demonstrated that REG can be used to detect spreading depolarization (SD), the early sign of brain metabolic disturbance. SD can be measured invasively with DC EEG amplifiers only. Our goal is to create an automatic notification function for REG monitoring indicating change of clinical conditions.
Read the detailed description
Neuromonitoring of patients with severe neurological illness are detailed elsewhere. In the setting of cerebral edema, ICP monitoring is a staple of neurocritical care. Pressure AR is an important hemodynamic mechanism that protects the brain against inappropriate fluctuations in CBF in the face of changing CPP. Both static and dynamic AR have been monitored in neurocritical care to aid prognostication and contribute to individualizing optimal CPP targets in patients. Theoretically, failure of cerebral AR is associated with poor outcomes in various acute neurological diseases. Continuous bedside monitoring of autoregulation is now feasible and should be considered as a part of multimodality monitoring including measurement of pressure reactivity. A previous study documented that REG (REGx) and ICP (PRx) has high correlation in order to detect the lower limit of CBF AR. The fundamental relationships between SAP, vessel tone, cerebral blood volume and ICP form the basis for the pressure reactivity index (PRx). PRx is analogous to other time domain AR indices and is calculated as the continuous correlation between thirty consecutive time-averaged (10 s) SAP and ICP values. A positive index (positive correlation) implies impaired passive CBF AR, while a negative index (inverse correlation) implies intact, active AR. The utility and feasibility of REG as a monitoring modality is previously demonstrated and validated as a reflection of cerebrovascular reactivity. The bioimpedance amplifier was used previously at Walter Reed Army Institute of Research (WRAIR) and Naval Medical Research Center (Silver Spring, MD); and has an FDA safety clearance. It is expected that REG can predict evolving vasospasm and expanding intracranial bleeding amongst several other clinical applications.
- Conditions
- Intracranial Pressure Increase, Cerebral Edema
- Keywords
- neuromonitoring, intracranial pressure (ICP), cerebral blood flow autoregulation, Rheoencephalography (REG), noninvasive neuromonitoring, cerebral edema, autoregulation, Cerebral Perfusion Pressure, Pressure reactivity index
- Medical subject headings
- Intracranial Hypertension, Brain Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow Autoregulation (CBF AR)
Cerebral Blood Flow Autoregulation (CBF AR) will be analyzed based on noninvasive recordings (bioimpedance) by using a dedicated software for this purpose (part of ICM+ program, incorporated into a WRAIR-made software (DataLyser)). In this case CBF AR is called REGx.
Measured: through hospital admission, an average of 10 days
Secondary outcomes (1)
ICP Elevation
Morphological analysis of REG pulse waveform in order to detect ICP elevation, and establish the correlation between REGx and REG pulse waveform morphology.
Measured: through hospital admission, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start18 Apr 2018
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Cannizzaro, MD, Principal investigator, Ochsner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170295
- Sponsor's protocol ID
- 2018.149
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Steiner LA, Andrews PJ. Monitoring the injured brain: ICP and CBF. Br J Anaesth. 2006 Jul;97(1):26-38. doi: 10.1093/bja/ael110. Epub 2006 May 12.
PubMed 16698860Donnelly J, Aries MJ, Czosnyka M. Further understanding of cerebral autoregulation at the bedside: possible implications for future therapy. Expert Rev Neurother. 2015 Feb;15(2):169-85. doi: 10.1586/14737175.2015.996552.
PubMed 25614952MCHENRY LC Jr. RHEOENCEPHALOGRAPHY: A CLINICAL APPRAISAL. Neurology. 1965 Jun;15:507-17. doi: 10.1212/wnl.15.6.507. No abstract available.
PubMed 14312772Traczewski W, Moskala M, Kruk D, Goscinski I, Szwabowska D, Polak J, Wielgosz K. The role of computerized rheoencephalography in the assessment of normal pressure hydrocephalus. J Neurotrauma. 2005 Jul;22(7):836-43. doi: 10.1089/neu.2005.22.836.
PubMed 16004585Bodo M, Simovic M, Pearce F, Ahmed A, Armonda R. Correlation of rheoencephalogram and intracranial pressure: results of a rat study. Physiol Meas. 2015 Oct;36(10):N115-26. doi: 10.1088/0967-3334/36/10/N115. Epub 2015 Sep 3.
PubMed 26334594Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Boesel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Robertson C, Schmidt M, Taccone F; Neurocritical Care Society; European Society of Intensive Care Medicine. Consensus summary statement of the International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care : a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Sep;40(9):1189-209. doi: 10.1007/s00134-014-3369-6. Epub 2014 Aug 20.
PubMed 25138226Harary M, Dolmans RGF, Gormley WB. Intracranial Pressure Monitoring-Review and Avenues for Development. Sensors (Basel). 2018 Feb 5;18(2):465. doi: 10.3390/s18020465.
PubMed 29401746Strandgaard S, Paulson OB. Cerebral autoregulation. Stroke. 1984 May-Jun;15(3):413-6. doi: 10.1161/01.str.15.3.413. No abstract available.
PubMed 6374982PEREZ-BORJA C, MEYER JS. A CRITICAL EVALUATION OF RHEOENCEPHALOGRAPHY IN CONTROL SUBJECTS AND IN PROVEN CASES OF CEREBROVASCULAR DISEASE. J Neurol Neurosurg Psychiatry. 1964 Feb;27(1):66-72. doi: 10.1136/jnnp.27.1.66. No abstract available.
PubMed 14123928Bodo 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 15712716Bodo 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 12751577Bodo 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 15798222Bodo M, Szebeni J, Baranyi L, Savay S, Pearce FJ, Alving CR, Bunger R. Cerebrovascular involvement in liposome-induced cardiopulmonary distress in pigs. J Liposome Res. 2005;15(1-2):3-14. doi: 10.1081/lpr-64523.
PubMed 16194924Armonda RA, Bell RS, Vo AH, Ling G, DeGraba TJ, Crandall B, Ecklund J, Campbell WW. Wartime traumatic cerebral vasospasm: recent review of combat casualties. Neurosurgery. 2006 Dec;59(6):1215-25; discussion 1225. doi: 10.1227/01.NEU.0000249190.46033.94.
PubMed 17277684Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Boesel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Robertson C, Schmidt M, Taccone F. Consensus summary statement of the International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care: a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Neurocrit Care. 2014 Dec;21 Suppl 2(Suppl 2):S1-26. doi: 10.1007/s12028-014-0041-5.
PubMed 25208678
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Monitoring of Cerebral Blood Flow Autoregulation
- ClinicalTrials.gov ID
- NCT05170295
- Acronym / sponsor ID
- 2018.149
- Conditions
- Intracranial Pressure Increase, Cerebral Edema
- Keywords
- neuromonitoring, intracranial pressure (ICP), cerebral blood flow autoregulation, Rheoencephalography (REG), noninvasive neuromonitoring, cerebral edema, autoregulation, Cerebral Perfusion Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rheoencephalography (REG) shows promise as a method for noninvasive neuromonitoring, because it reflects cerebrovascular reactivity. This protocol will study clinical and technical conditions required to use REG. Additionally, our goal is to study noninvasive peripheral bioimpedance pulse waveforms in order to substitute invasive SAP. A previous study demonstrated that REG can be used to detect spreading depolarization (SD), the early sign of brain metabolic disturbance. SD can be measured invasively with DC EEG amplifiers only. Our goal is to create an automatic notification function for REG monitoring indicating change of clinical conditions.
Detailed description
Neuromonitoring of patients with severe neurological illness are detailed elsewhere. In the setting of cerebral edema, ICP monitoring is a staple of neurocritical care. Pressure AR is an important hemodynamic mechanism that protects the brain against inappropriate fluctuations in CBF in the face of changing CPP. Both static and dynamic AR have been monitored in neurocritical care to aid prognostication and contribute to individualizing optimal CPP targets in patients. Theoretically, failure of cerebral AR is associated with poor outcomes in various acute neurological diseases. Continuous bedside monitoring of autoregulation is now feasible and should be considered as a part of multimodality monitoring including measurement of pressure reactivity. A previous study documented that REG (REGx) and ICP (PRx) has high correlation in order to detect the lower limit of CBF AR. The fundamental relationships between SAP, vessel tone, cerebral blood volume and ICP form the basis for the pressure reactivity index (PRx). PRx is analogous to other time domain AR indices and is calculated as the continuous correlation between thirty consecutive time-averaged (10 s) SAP and ICP values. A positive index (positive correlation) implies impaired passive CBF AR, while a negative index (inverse correlation) implies intact, active AR. The utility and feasibility of REG as a monitoring modality is previously demonstrated and validated as a reflection of cerebrovascular reactivity. The bioimpedance amplifier was used previously at Walter Reed Army Institute of Research (WRAIR) and Naval Medical Research Center (Silver Spring, MD); and has an FDA safety clearance. It is expected that REG can predict evolving vasospasm and expanding intracranial bleeding amongst several other clinical applications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve patients of Neurocritical Care Department with clinical suspicion of elevated intracranial pressure.
Key inclusion criteria (3 listed)
- Intact fronto-temporal area
- Intact lower arm area
- Clinical suspicion of elevated intracranial pressure
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cerebral Blood Flow Autoregulation (CBF AR)
Time frame: through hospital admission, an average of 10 days
Cerebral Blood Flow Autoregulation (CBF AR) will be analyzed based on noninvasive recordings (bioimpedance) by using a dedicated software for this purpose (part of ICM+ program, incorporated into a WRAIR-made software (DataLyser)). In this case CBF AR is called REGx.
1 secondary outcome
ICP Elevation
Time frame: through hospital admission, an average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Background: PubMed 16698860Steiner LA, Andrews PJ. Monitoring the injured brain: ICP and CBF. Br J Anaesth. 2006 Jul;97(1):26-38. doi: 10.1093/bja/ael110. Epub 2006 May 12.
- Background: PubMed 25614952Donnelly J, Aries MJ, Czosnyka M. Further understanding of cerebral autoregulation at the bedside: possible implications for future therapy. Expert Rev Neurother. 2015 Feb;15(2):169-85. doi: 10.1586/14737175.2015.996552.
- Background: PubMed 14312772MCHENRY LC Jr. RHEOENCEPHALOGRAPHY: A CLINICAL APPRAISAL. Neurology. 1965 Jun;15:507-17. doi: 10.1212/wnl.15.6.507. No abstract available.
- Background: PubMed 16004585Traczewski W, Moskala M, Kruk D, Goscinski I, Szwabowska D, Polak J, Wielgosz K. The role of computerized rheoencephalography in the assessment of normal pressure hydrocephalus. J Neurotrauma. 2005 Jul;22(7):836-43. doi: 10.1089/neu.2005.22.836.
- Background: PubMed 26334594Bodo M, Simovic M, Pearce F, Ahmed A, Armonda R. Correlation of rheoencephalogram and intracranial pressure: results of a rat study. Physiol Meas. 2015 Oct;36(10):N115-26. doi: 10.1088/0967-3334/36/10/N115. Epub 2015 Sep 3.
- Background: PubMed 25138226Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Boesel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Robertson C, Schmidt M, Taccone F; Neurocritical Care Society; European Society of Intensive Care Medicine. Consensus summary statement of the International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care : a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Sep;40(9):1189-209. doi: 10.1007/s00134-014-3369-6. Epub 2014 Aug 20.
- Background: PubMed 29401746Harary M, Dolmans RGF, Gormley WB. Intracranial Pressure Monitoring-Review and Avenues for Development. Sensors (Basel). 2018 Feb 5;18(2):465. doi: 10.3390/s18020465.
- Background: PubMed 6374982Strandgaard S, Paulson OB. Cerebral autoregulation. Stroke. 1984 May-Jun;15(3):413-6. doi: 10.1161/01.str.15.3.413. No abstract available.
- Background: PubMed 14123928PEREZ-BORJA C, MEYER JS. A CRITICAL EVALUATION OF RHEOENCEPHALOGRAPHY IN CONTROL SUBJECTS AND IN PROVEN CASES OF CEREBROVASCULAR DISEASE. J Neurol Neurosurg Psychiatry. 1964 Feb;27(1):66-72. doi: 10.1136/jnnp.27.1.66. No abstract available.
- Background: PubMed 15712716Bodo 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.
- Background: PubMed 12751577Bodo 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.
- Background: PubMed 15798222Bodo 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.
- ICM+Link provided by the sponsor.
- Monitoring cerebrovascular pressure reactivity with rheoencephalographyLink provided by the sponsor.
- In vivo cerebral blood flow autoregulation studies using rheoencephalographyLink provided by the sponsor.
- Comparison of cerebrovascular reactivity tests: a pilot human studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Cannizzaro, MD principal investigator
Ochsner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Increase and Cerebral Edema, run by Ochsner Health System 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 1 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: finished, as of the sponsor's last update on 27 Dec 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cerebral Blood Flow Autoregulation (CBF AR) (time frame: through hospital admission, an average of 10 days). 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 NCT05170295, which also lists 15 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 27 Dec 2021.