Cerebral VasospasmEarly Phase 1NCT01343537
Continuous Neurophysiological Monitoring Detection of Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage Subjects
A Early Phase 1 study testing Neuro Monitoring in people with Cerebral Vasospasm and SAH, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Aneurysmal subarachnoid hemorrhage (bleeding on the brain due to a ruptured aneurysm) is a serious condition with a high morbidity (incidence of having ill health) and mortality (death). There are approximately 11 cases per 100,000 in the population per year, and approximately 40% of these cases are fatal. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cerebral Vasospasm, SAH, Aneurysm
- What is being tested?
- Neuro Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Mar 2014
- Phase
- Early Phase 1
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
All adult subjects who have a subarachnoid hemorrhage from a ruptured aneurysm and require high levels of sedation, or a poor neurologic exam and mechanical ventilation will be eligible for the study. Hunt and Hess Grade 4 and 5(worst grades; highest mortality; highest level of dependence if survived) subarachnoid hemorrhage subjects by definition have a severely depressed exam, and will require intubation and mechanical ventilation. Those subjects whose respiratory status deteriorates necessitating intubation and high levels of sedation will also qualify.
All subjects who have subarachnoid hemorrhage from undetermined source, such as angiogram negative subarachnoid hemorrhage, those who have a reliable neurological exam such as Hunt and Hess grade 1-3 subarachnoid hemorrhage subjects, and those who are intubated, but require minimal sedation and therefore have a consistent neurological exam will be excluded from the study. Also, any subject that has a body temperature of less then 32 degrees Celsius will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Real Time Continuous Neurophysiological Monitoring for Early Detection of Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage Subjects
Aneurysmal subarachnoid hemorrhage (bleeding on the brain due to a ruptured aneurysm) is a serious condition with a high morbidity (incidence of having ill health) and mortality (death). There are approximately 11 cases per 100,000 in the population per year, and approximately 40% of these cases are fatal. (Ingall) Among the fortunate subjects who survive the initial bleed, vasospasm and subsequent stroke are a major cause of morbidity. Vasospasm is defined as a prolonged severe, although reversible cause of arterial narrowing that occurs after bleeding into the subarachnoid space, most commonly after aneurysmal rupture. (Youman) The reduced arterial diameter inhibits blood flow and deprives the brain of oxygen, which often results in a stroke.
Vasospasm is a major problem when treating subjects with aneurysmal subarachnoid hemorrhage. For these reasons, it is essential to diagnose cerebral vasospasm early, before permanent deficits develop.
Read more
There may be another option to solve this dilemma. The field of neuro-monitoring (neurological monitoring) has the technology available to continuously monitor brain activity of these sedated ICU subjects. This may allow for early diagnosis and possibly identify changes in neurologic function before they become symptomatic. In the past, neuro-monitoring was primarily used in the operating room to monitor neurologic function during surgery in and around the spinal cord. Surgery to the spine or spinal cord also carries its own form of risk, either from mechanical trauma to the spinal cord or its nerve roots, or from interruption of the blood supply to these structures. Should damage to nerve fibers occur, the end result could be paralysis, loss of sensation, and onset of severe burning (i.e. neuropathic) pain. The field of intraoperative neuro-monitoring (IOM) was developed to address these risks during spine surgery, whereby nerves rostral (toward the head) or caudal (toward the feet) to the site of surgery are stimulated (usually via electrical pulses) and signals are recorded from the side opposite to the site of stimulation. Thus, the signals carried by nerve fibers are forced to pass through the region at risk from the surgery. In the event that changes in nerve responses are seen, the surgical team is notified, and they can change what they're doing to try and restore signals, thereby preserving function in the nerve fibers.
This same technology has been used in the neurosurgical ICU to monitor subjects with severe brain injury from trauma, stroke, intracranial hemorrhage and subarachnoid hemorrhage. Using continuous electroencephalogram (EEG) monitoring combined with somatosensory evoked potentials (SSEPs) (a type of neuro monitoring) has been used to determine prognosis, identify subjects in subclinical status epilepticus (state of brain being in a constant seizure), predict elevations in the intracranial pressure Increased pressure within the skull), and diagnose cerebral hypoxia (not enough oxygen in the brain) (Amantini)
Read the detailed description
Aneurysmal subarachnoid hemorrhage is a serious condition with a high morbidity and mortality. There are approximately 11 cases per 100,000 population per year, and approximately 40% of these cases are fatal. (Ingall) Among the fortunate subjects who survive the initial bleed, vasospasm and subsequent stroke are a major cause of morbidity. Vasospasm is defined as a prolonged severe, although reversible cause of arterial narrowing that occurs after bleeding into the subarachnoid space, most commonly after aneurismal rupture. (Youman) The reduced arterial diameter inhibits blood flow and deprives the brain of oxygen, which often results in a stroke.
Vasospasm is a major problem when treating subjects with aneurismal subarachnoid hemorrhage. Up to 75% of subjects with aneurismal subarachnoid hemorrhage will develop vasospasm, and 30% of subarachnoid hemorrhage subjects will become clinically symptomatic, with muscle weakness as the primary symptom. (Dorsch) Even with intervention, 12% of patents with symptomatic vasospasm will develop permanent clinical deficits (after a ruptured aneurysm) including hemiplegia, aphasias, and visual loss. Less severe strokes may lead to modest loss of strength and sensation on one side of the body, and/or deterioration in higher brain functions, such as memory, speech comprehension, and planning.
Continuous Neuro-monitoring has previously been used in the trauma ICU setting as a means to detect deterioration in brain function after closed head injury (Amantini, Daubin), ischemic encephalopathy (Hakimi) and in subjects with MCA stroke to determine function (Tzvetanov). It was also observed that monitoring changes occur prior to ICP elevations in critically ill subjects (Amantini). These studies have demonstrated the feasibility as well as the safety of monitoring in an ICU.
No studies to date have attempted monitoring for vasospasm in subjects who suffered an aneurysmal subarachnoid hemorrhage. Motor evoked potential have also not been trialed in the ICU, although MEP may be more useful to determine both cerebral ischemia, as well as functional outcome.
- Conditions
- Cerebral Vasospasm, SAH, Aneurysm
- Being tested
- Neuro Monitoring
- Keywords
- Brain Bleed, SAH, Vasospasm
- Medical subject headings
- Vasospasm, Intracranial, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro MonitoringOther
Neuro monitoring from day 4 to day 14 post subarachnoid hemorrhage for cerebral vasospasm
| Study group | Role | What they receive |
|---|---|---|
| Monitoring | Experimental | Not described Receives: Other: Neuro Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of cerebral vasospasm after aneurysmal subarachnoid hemorrhage
To determine the feasibility and safety using intermittent motor evoked potentials, somatosensory evoked potentials and EEG monitoring to detect vasospasm compared against our standard detection methods including transcranial doppler ultrasound, computed tomography angiogram, computed tomography perfusion scan and the gold standard: formal cerebral angiography
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral VasospasmStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric M Deshaies, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343537
- Sponsor's protocol ID
- 5981
- Status last verified
- Apr 2011
- First submitted
- 26 Apr 2011
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Time Continuous Neurophysiological Monitoring for Early Detection of Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage Subjects
- ClinicalTrials.gov ID
- NCT01343537
- Acronym / sponsor ID
- 5981
- Conditions
- Cerebral Vasospasm, SAH, Aneurysm
- Keywords
- Brain Bleed, SAH, Vasospasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Apr 2011 (estimated)
- 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.
Aneurysmal subarachnoid hemorrhage (bleeding on the brain due to a ruptured aneurysm) is a serious condition with a high morbidity (incidence of having ill health) and mortality (death). There are approximately 11 cases per 100,000 in the population per year, and approximately 40% of these cases are fatal. (Ingall) Among the fortunate subjects who survive the initial bleed, vasospasm and subsequent stroke are a major cause of morbidity. Vasospasm is defined as a prolonged severe, although reversible cause of arterial narrowing that occurs after bleeding into the subarachnoid space, most commonly after aneurysmal rupture. (Youman) The reduced arterial diameter inhibits blood flow and deprives the brain of oxygen, which often results in a stroke.
Vasospasm is a major problem when treating subjects with aneurysmal subarachnoid hemorrhage. For these reasons, it is essential to diagnose cerebral vasospasm early, before permanent deficits develop.
There may be another option to solve this dilemma. The field of neuro-monitoring (neurological monitoring) has the technology available to continuously monitor brain activity of these sedated ICU subjects. This may allow for early diagnosis and possibly identify changes in neurologic function before they become symptomatic. In the past, neuro-monitoring was primarily used in the operating room to monitor neurologic function during surgery in and around the spinal cord. Surgery to the spine or spinal cord also carries its own form of risk, either from mechanical trauma to the spinal cord or its nerve roots, or from interruption of the blood supply to these structures. Should damage to nerve fibers occur, the end result could be paralysis, loss of sensation, and onset of severe burning (i.e. neuropathic) pain. The field of intraoperative neuro-monitoring (IOM) was developed to address these risks during spine surgery, whereby nerves rostral (toward the head) or caudal (toward the feet) to the site of surgery are stimulated (usually via electrical pulses) and signals are recorded from the side opposite to the site of stimulation. Thus, the signals carried by nerve fibers are forced to pass through the region at risk from the surgery. In the event that changes in nerve responses are seen, the surgical team is notified, and they can change what they're doing to try and restore signals, thereby preserving function in the nerve fibers.
This same technology has been used in the neurosurgical ICU to monitor subjects with severe brain injury from trauma, stroke, intracranial hemorrhage and subarachnoid hemorrhage. Using continuous electroencephalogram (EEG) monitoring combined with somatosensory evoked potentials (SSEPs) (a type of neuro monitoring) has been used to determine prognosis, identify subjects in subclinical status epilepticus (state of brain being in a constant seizure), predict elevations in the intracranial pressure Increased pressure within the skull), and diagnose cerebral hypoxia (not enough oxygen in the brain) (Amantini)
Detailed description
Aneurysmal subarachnoid hemorrhage is a serious condition with a high morbidity and mortality. There are approximately 11 cases per 100,000 population per year, and approximately 40% of these cases are fatal. (Ingall) Among the fortunate subjects who survive the initial bleed, vasospasm and subsequent stroke are a major cause of morbidity. Vasospasm is defined as a prolonged severe, although reversible cause of arterial narrowing that occurs after bleeding into the subarachnoid space, most commonly after aneurismal rupture. (Youman) The reduced arterial diameter inhibits blood flow and deprives the brain of oxygen, which often results in a stroke.
Vasospasm is a major problem when treating subjects with aneurismal subarachnoid hemorrhage. Up to 75% of subjects with aneurismal subarachnoid hemorrhage will develop vasospasm, and 30% of subarachnoid hemorrhage subjects will become clinically symptomatic, with muscle weakness as the primary symptom. (Dorsch) Even with intervention, 12% of patents with symptomatic vasospasm will develop permanent clinical deficits (after a ruptured aneurysm) including hemiplegia, aphasias, and visual loss. Less severe strokes may lead to modest loss of strength and sensation on one side of the body, and/or deterioration in higher brain functions, such as memory, speech comprehension, and planning.
Continuous Neuro-monitoring has previously been used in the trauma ICU setting as a means to detect deterioration in brain function after closed head injury (Amantini, Daubin), ischemic encephalopathy (Hakimi) and in subjects with MCA stroke to determine function (Tzvetanov). It was also observed that monitoring changes occur prior to ICP elevations in critically ill subjects (Amantini). These studies have demonstrated the feasibility as well as the safety of monitoring in an ICU.
No studies to date have attempted monitoring for vasospasm in subjects who suffered an aneurysmal subarachnoid hemorrhage. Motor evoked potential have also not been trialed in the ICU, although MEP may be more useful to determine both cerebral ischemia, as well as functional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring | Experimental | Other: Neuro Monitoring |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro MonitoringNeuro monitoring from day 4 to day 14 post subarachnoid hemorrhage for cerebral vasospasm | Other | Monitoring |
Primary outcome
Early detection of cerebral vasospasm after aneurysmal subarachnoid hemorrhage
Time frame: One year
To determine the feasibility and safety using intermittent motor evoked potentials, somatosensory evoked potentials and EEG monitoring to detect vasospasm compared against our standard detection methods including transcranial doppler ultrasound, computed tomography angiogram, computed tomography perfusion scan and the gold standard: formal cerebral angiography
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
Related trials for Cerebral Vasospasm
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Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
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Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
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The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Cerebral
RecruitingObservational study
Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage
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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.
Eric M Deshaies, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neuro Monitoring in people with Cerebral Vasospasm and SAH, run by State University of New York - Upstate Medical University 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?
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: stopped early, as of the sponsor's last update on 1 Jan 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Early detection of cerebral vasospasm after aneurysmal subarachnoid hemorrhage (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2016.