Continuous Neurophysiological Monitoring Detection of Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage Subjects

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. (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)

Conditions

• Cerebral Vasospasm
• SAH
• Aneurysm

Interventions

OTHER

Neuro Monitoring

Neuro monitoring from day 4 to day 14 post subarachnoid hemorrhage for cerebral vasospasm

Sponsors & Collaborators

• State University of New York - Upstate Medical University

  lead OTHER

Principal Investigators

• Eric M Deshaies, MD · State University of New York - Upstate Medical University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• United States

Study Locations