A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury

The study population will consist of 3 mutually-exclusive sets of patients and subjects:

* TBI patients with intracranial bleeding * TBI patients without intracranial bleeding * Control subjects with normal brain health.

Research subjects between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Grady, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who meet all of the following inclusion criteria will be considered candidates for study enrollment:

Male or female subjects age 22 to 50
Patients with TBI who have a diagnostic head CT scan within 24 hours of the injury.
For patients with TBI without intracranial hemorrhage, Glasgow Coma Scale score at enrollment of ≤ 14.
For patients with TBI, intended clinical monitoring in the hospital setting for at least 6 hours from study enrollment.
Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian.
Willingness and ability to comply with schedule for study procedures.
Control subjects with normal brain health.

Exclusion criteria

All subjects meeting any of the following criteria will be excluded from this study:

Female patients who are pregnant or lactating.
Known history of seizure or clinical seizure prior to initiating SENSE monitoring.
Open skull fracture.
Metallic intracranial clip, coil, or device (such as metallic ICP monitor).
Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring or study participation or may confound the outcome of the study.
Planned placement of an intraventricular catheter after the diagnostic (pre-enrollment) CT.
Planned withdrawal of care within 24 hours of enrollment.
Planned intracranial surgery within 24 hours of enrollment.
Current participation in a medical or surgical interventional clinical trial.
Planned or current use of continuous EEG monitoring.
Control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, TBI

Treatment and study plan

SDx3

Device

The SENSE Device (SDx3) is a non-invasive device that detects differences in the absorption of transmitted RF energy across the skull and brain and is intended to be used to evaluate intracranial hemorrhage.

Primary outcomes

Compare ICH in TBI patients to non-ICH control subjects

Time frame: up to 12 months
- Distinguish TBI subjects with intracranial hemorrhage from those without intracranial hemorrhage and from non-TBI controls.
Measure growth of intracranial hemorrhage

Time frame: up to 12 months
- Detect new or enlarging intracranial hemorrhage of ≥ 6 ml among TBI subjects, as defined by CT scan.

Sponsors and collaborators

Lead sponsor

Sense Diagnostics, LLC

Industry

Registry information

Official study title

A Prospective, Non-Randomized, Sequentially Enrolled, Multi-Center, Phase II Study to Evaluate the SENSE Device's Ability to Detect and Monitor Traumatic Brain Injury

Acronym: Sense-005

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Dec 14, 2021
Registry last updated: Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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