Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients

The HS-1000 is an innovative non-invasive intracranial pressure (ICP) monitoring device that
employs advanced acoustic signal analysis to derive ICP on a continuous basis. The first
version of the device was clinically validated in trials in Italy, India, and Armenia.
Overall, more than 10,000 ICP measurements were collected from both patients and healthy
subjects. The device is currently undergoing FDA validation in an adult cohort across eight
sites in the United States.

This will be a pilot study conducted at Akron Children's Hospital. A maximum of 40 patients
with severe traumatic brain injury (TBI) or neurological conditions requiring ICP monitoring
will be studied over 2 years. All patients treated with either surgical ICP monitor
(external ventricular drain [EVD] or subarachnoid manometer [Bolt]) are eligible for study
enrollment. The HS-1000 device will be deployed as soon as possible after surgical ICP
monitor placement to record and collect data in parallel with the surgical device.

To assess the accuracy and safety of the HS-1000 device as an alternative to the invasive
ICP procedure, the investigators will compare ICP readings obtained by the HS-1000
monitoring system to measurements recorded by the surgical device during 15-30 minute
recording sessions.

ICP readings will be recorded from both the invasive and HeadSense non-invasive ICP monitor
for an aggregate of 30 minutes. During the recording sessions, a webcam will take periodic
snapshots of the ICP monitor and/or bedside monitor picturing the ICP values and other
clinical parameters that are displayed on screen, with a focus on blood pressure and heart
rate (HR). Recording sessions will be done until an aggregate of at least 30 minutes of data
are collected, depending on the patient's clinical condition. Recording sessions may be
repeated over several days until the 30 minute target is reached.

The HeadSense headset is removed between recordings. Recording should be done only in case
the patient's clinical condition allows it (i.e. patient is in supine position and does not
require any clinical intervention or treatment at the time of the recording). In case the
patient requires some clinical intervention the recording will be stopped and will be
resumed only after the intervention is done and the patient's clinical condition allows
resuming of the recording.

Lastly, the investigators will also place a commercial sound meter in the participant's room
to collect baseline data on exposure to ambient noise within the Pediatric Intensive Care
Unit (PICU) treatment environment. This data will facilitate a device-vs-ambient sound
comparison, a component of the device safety profile.

Study patient demographics will be collected to include patient medical record number, age,
gender, diagnosis, medical information, and the patient's clinical course pertinent to the
ICP monitoring until the attending physician determines invasive ICP measurement is no
longer necessary. Additional demographic, diagnostic parameters, severity of illness
calculations, and procedures will be obtained from the Virtual Pediatric Systems (VPS, LLC)
Pediatric Intensive Care Unit clinical outcomes database. The patient will be followed for
48 hours post ICU discharge for any adverse events.

The diagnosis of head trauma or other medical conditions indicating a need for ICP
monitoring, the decision to place an intraventricular catheter and the duration of ICP
monitoring are at the discretion of the patient's clinical care team and independent of this
study. With the exception of simultaneous use of the non-invasive acoustical HS-1000
monitoring system and ambient noise level measurements within the patient's room, all other
patient care, including clinical evaluations and treatments, is independent of this study.
No HS-1000 data will be displayed and will not be used in clinical decision making.

Inclusion Criteria:

- Males and females <= 18 years old admitted to the PICU whose treatment includes a
surgical ICP monitor.

- Subject or legal authorized representative (per local regulation) is able and willing
to comply with the requirements of the protocol

- Subject or legal authorized representative (per local regulation) is able to
understand and sign written informed consent to participate in the study

Exclusion Criteria:

- Subject with an invasive ICP monitor placed Ten (10) days or before the date of
recording for EVD monitor OR Five (5) days or before the date of recording for Bolt
monitor

- Subjects with more than one invasive ICP monitor in place at the time of recording

- Ear disease/ear trauma

- Subjects with severe head trauma in which the location and/or severity of the skull
fracture(s), i.e. frank skull fracture or major joint dislocations with parenchyma
exposed to room pressure, may jeopardize HeadSense monitoring procedure
[Post-craniotomy patients with intact dura and accurate ICP values from the invasive
EVD are eligible.]

- Severe TBI that jeopardizes HS-1000 monitoring procedure

- Cerebral spinal fluid (CSF) otorrhea

- Allergy/Hypersensitivity to test materials

- Pregnant or breast feeding

- Current enrollment (or within 30 days) in another investigational device or drug
study, OR receiving an investigational agent

- Any condition that jeopardizes study participation (abnormal clinical/lab finding)