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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01595802
First received: February 14, 2012
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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 Intervention
Cerebral Vasospasm
Device: Nautilus NeuroWaveTM System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, 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

Further study details as provided by Jan Medical, Inc.:

Primary Outcome Measures:
  • Sensitivity as a diagnostic aid in detecting vasospasm in subarachnoid hemorrhage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Outcome determine Upon completion of study and unmaksing

  • Specificity as a diagnostic aid in detection of vasospasm in subarachnoid hemorrhage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Outcome determined upon completion of study and unmasking


Secondary Outcome Measures:
  • Location of vasospasm in the caranium [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    outcome determine upon completion of study and unmasking

  • Incidence of device related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: January 2012
Study Completion Date: October 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Recording Arm
subjects with Neuro Wave Recording
Device: Nautilus NeuroWaveTM System
A noninvasive device to detect cerebral vasospasm utilizing headset and sensors

  Hide Detailed Description

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595802

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 (UCSF)
  More Information

No publications provided

Responsible Party: Jan Medical, Inc.
ClinicalTrials.gov Identifier: NCT01595802     History of Changes
Other Study ID Numbers: DC1B-01
Study First Received: February 14, 2012
Last Updated: October 17, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014