An Innovative Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm

A Retrospective, Open-Label, Non-Randomized, Study Designed to Evaluate the Correlation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Vasospasm Patients After Sub Arachnoid Hemorrhage

The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy, highly operator dependent and more.

HS-1000 device, an investigational vasospasm detection device, has the potential to safely diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality for vasospasm measurement tool.

We aim to evaluate the correlation between the collected and analyzed data from the HS-1000 device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH) patients.

Study Overview

• Status: Withdrawn
• Conditions: Vasospasm; Sub Arachnoid Hemorrhage

• Study Type: Observational

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

SAH patients with an expected TCD test

Description

Inclusion Criteria:

• SAH patients with a TCD test
• Male or Female in the age range of 18-85 years
• Expected survival > 14 days

Exclusion Criteria:

• Local infection in the ear.
• Pregnant/lactating women
• Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
• Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
• Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition) Note: As the trial does not affect the patient's management, there is no limitation regarding patient's medications, previous or post study procedures, etc.

Enrolled patients treatment will not change due to their participation in the trial

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy analysis	The main goal of the study is to check the feasibility of the HeadSense's non-invasive head monitor to check vasospasm in patients which over went SAH. In order to validate the accuracy of the HeadSense's device, a statistical comparison will be done between the acoustic values from the Headsense device and the TCD outcome.	within the first 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety analysis	The HeadSense device is non-invasive and radiation free, therefore no major safety issues are expected. During the trial, the patient will be monitored to make sure that no danger or damage is caused by the device. Although there is a small chance of adverse events, potential safety issues include: Perforation of the ear drum, caused by inserting the device to the patient's ears; Allergic reaction caused by skin contact with the device (the parts that are attached to the skin are taken from an off the shelf stethoscope, so this is very unlikely to happen); Damage to hearing, caused by the generated sound (the sound is 10Db in strength and is being generated for 10 seconds, so hearing damage is very unlikely to happen	within the first 48 hours

Collaborators and Investigators

• Sponsor: HeadSense Medical

Study record dates

Study Major Dates

• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: March 19, 2014
• First Posted (Estimate): March 20, 2014

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 21, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: HS-007; 0026-14-TLV (Other Identifier: Tel Aviv Sourasky Medical Center)