Non-Significant Risk Study Comparing the Nautilus NeuroWaveTM to Transcranial Doppler as an Aid to Diagnosing Vasospasm

• ClinicalTrials.gov Identifier: NCT01595802
• Recruitment Status: Completed
• First Posted: May 10, 2012
• Last Update Posted: February 25, 2016
• Sponsor: Jan Medical, Inc.
• Information provided by (Responsible Party): Jan Medical, Inc.

Study Description

Brief Summary:

The purpose of the study is to determine the sensitivity, specificity and predictive values of the Jan Medical NeuroWave System in detecting moderate and severe vasospasm in comparison to Trans Cranial Doppler(TCD).

Condition or disease	Intervention/treatment	Phase
Cerebral Vasospasm	Device: Nautilus NeuroWave; Device: Transcranial Doppler (TCD)	Not Applicable

Detailed Description:

Cerebral vasospasm generally occurs due to a ruptured brain aneurysm, or (very rarely) hemorrhage from another blood vessel abnormality such as an arteriovenous malformation (AVM). The common factor is the abnormal presence of a substantial amount of blood on the outer ("subarachnoid" or "adventitial") surface of the blood vessel. This can particularly affect arteries at the base of the brain, i.e., around the Circle of Willis.

Depending on the severity, this can be seen using conventional angiography. Angiographic spasm tends to be most readily detected at about 5-7 days after the SAH, although it may be detected as early as 3 days after the hemorrhage. It occurs in between half to two-thirds of all aneurysm patients depending on the time at which angiography was carried out. Clinical vasospasm occurs in approximately one-third of all patients suffering aneurysmal SAH.

The essential problem with vasospasm is that it causes an artery to reduce blood flow or completely shut down. As a result, the part of the brain formerly supplied by that artery effectively starves (ischemia) and may die (infarction or stroke). Overall, cerebral vasospasm accounts for approximately 20% of the severe disability and death associated with ruptured aneurysms.

If vasospasm is detected early, a patient can be treated with balloon angioplasty to reopen the vessels or have infusions of a vasodilator administered (typically verapamil or nicardipine). Alternatively, or in concert with that treatment, one can administer intravenous drugs that raise the patient's blood pressure ("pressors") to force more blood through the narrow arteries. Both of these treatments carry risk and therefore should not be administered unless vasospasm is detected. Therefore, in order to prevent this form of brain injury and enhance the likelihood that a patient will do better, one needs to detect vasospasm before it becomes severe enough to injure the brain.

Vasospasm can be detected by the signs observed on physical examination of the patient and by radiological methods such as cerebral angiography, and Trans-Cranial Doppler (TCD) ultrasound. The physical exam is sensitive for vasospasm in patients who are otherwise awake and able to participate in a neurological examination. Many patients with subarachnoid hemorrhage are not keenly aware nor participative to make this clinical exam meaningful. Therefore clinical examination alone lacks sensitivity.

The gold standard method for detecting vasospasm is cerebral angiography. This involves injection of a radiopaque dye into the arterial blood stream of a patient and when the dye reaches the brain X-rays are taken. Although this is the gold-standard for diagnosing vasospasm it carries the risk of arterial injury or even stroke, and the expense is high. In addition the contrast dye used in these studies carries the risk of renal failure. As a result, this technology is generally employed once vasosapasm is suspected from a Trans Cranial Doppler (TCD) study.

TCD is a bedside test that relies on ultrasound waves generated from a probe placed on the skin of the head and/or neck region to detect the flow of blood in a cerebral artery. It is a convenient, safe, and frequently effective method that can be used to rapidly confirm the clinical findings, and is much less invasive than cerebral angiography. It has, however, numerous technical limitations; for example, one can only detect vasospasm in the proximal vessels of the circle of Willis and therefore lacks sensitivity. It is also quite operator dependent and limited to patients with appropriate skull thickness and acoustic windows.

What is needed is a non-invasive, user independent, safe method to detect cerebral vasospasm before it causes brain injury. The technology needs to be simple to use and can be done at the bedside in an ICU environment. Such a tool will likely improve patient outcome by initiating a chain of events that can mitigate vasospasm (cerebral angioplasty or initiation of vasopressor therapy) and will likely shorten the length of stay within the Neuro ICU saving hospitals money.

The Jan Medical NeuroWave is a simple, rapid, non invasive aid to the diagnosis of vasospasm that is not operator dependent nor limited by skull structure. This study will determine the sensitivity, specificity and predictive values of the Jan Medical NeuroWave System in detecting moderate and severe vasospasm in comparison to Trans Cranial Doppler (TCD).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: A Non-Randomized, Non-Significant Risk Study Comparing the Nautilus NeuroWaveTM System to Transcranial Doppler as an Aid to Diagnosing Vasospasm
• Study Start Date: January 2012
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Subjects without Vasospasm; Transcranial Doppler (TCD) will be used to evaluate if subject has a vasospasm. Intervention with Nautilus NeuroWave recording to obtain baseline status.	Device: Nautilus NeuroWave; The Nautilus NeuroWave device will be utilized on subjects with sub-arachnoid hemorrhage that undergo TCD measurements to diagnose Vasospasm. A recording will be obtained using the device each time a TCD measurement is made. In this intervention, patients are recorded using the Nautilus Neurowave device.; Device: Transcranial Doppler (TCD); Subjects with sub-arachnoid hemorrhage undergo TCD measurements to diagnose Vasospasm. Patients that were detected to have a vasospasm using TCD will also be classified as having mild, moderate and severe vasospasm.
Experimental: Subjects with Vasospasm; Transcranial Doppler (TCD) will be used to evaluate if subject has a vasospasm. If confirmed by TCD, the degree of vasospasm will also be evaluated and classified as mild, moderate and severe Vasospasm. Intervention with Nautilus NeuroWave recording to obtain recordings with mild, moderate and severe Vasospasm.	Device: Nautilus NeuroWave; The Nautilus NeuroWave device will be utilized on subjects with sub-arachnoid hemorrhage that undergo TCD measurements to diagnose Vasospasm. A recording will be obtained using the device each time a TCD measurement is made. In this intervention, patients are recorded using the Nautilus Neurowave device.; Device: Transcranial Doppler (TCD); Subjects with sub-arachnoid hemorrhage undergo TCD measurements to diagnose Vasospasm. Patients that were detected to have a vasospasm using TCD will also be classified as having mild, moderate and severe vasospasm.

Outcome Measures

Primary Outcome Measures :

1. Sensitivity and specificity as a diagnostic aid in detecting vasospasm in subarachnoid hemorrhage [ Time Frame: 12 months ]
   Outcome determine Upon completion of study and unmaksing

Secondary Outcome Measures :

1. Location of vasospasm in the caranium [ Time Frame: 12 months ]
   outcome determine upon completion of study and unmasking
2. Incidence of device related adverse events [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female subjects 18 years of age or older.
• Subjects with subarachnoid hemorrhage who are receiving clinical and diagnostic surveillance for vasospasm.
• Signed informed consent from the patient or the patient's Legally Authorized Representative

Exclusion Criteria:

• Unstable medical illness such that recordings might interfere with medical care.
• Presence of head bandages or brain monitors that might physically interfere with the tested recording device.
• Current hemicraniectomy.
• Subjects who are not candidates for Transcranial Doppler assessment

Contacts and Locations

Locations

United States, California

University of California San Francisco (UCSF)

San Francisco, California, United States, 94142-0114

Sponsors and Collaborators

Jan Medical, Inc.

Investigators

• Principal Investigator: Wade Smith, M.D, PH.D.; University of California, San Francisco

More Information

• Responsible Party: Jan Medical, Inc.
• ClinicalTrials.gov Identifier: NCT01595802
• Other Study ID Numbers: DC1B-01
• First Posted: May 10, 2012
• Last Update Posted: February 25, 2016
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Jan Medical, Inc.:

Cerebral vasospasm

Additional relevant MeSH terms:

Vasospasm, Intracranial; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases