Sense-005: A Phase II Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury

Sponsor

Sense Diagnostics, LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05155800

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Device: SDx3

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
TBI patients with intracranial bleeding	Device: SDx3 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.
TBI patients without intracranial bleeding	Device: SDx3 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.
Control Subjects with normal brain health	Device: SDx3 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.

Arm

Intervention/Treatment

TBI patients with intracranial bleeding

Device: SDx3

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.

TBI patients without intracranial bleeding

Device: SDx3

Control Subjects with normal brain health

Device: SDx3

Outcome Measures

Primary Outcome Measures

Compare ICH in TBI patients to non-ICH control subjects [up to 12 months]
1. Distinguish TBI subjects with intracranial hemorrhage from those without intracranial hemorrhage and from non-TBI controls.
Measure growth of intracranial hemorrhage [up to 12 months]
2. Detect new or enlarging intracranial hemorrhage of ≥ 6 ml among TBI subjects, as defined by CT scan.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sense Diagnostics, LLC

Investigators

Principal Investigator: Jonathan Ratcliff, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sense Diagnostics, LLC

ClinicalTrials.gov Identifier:

NCT05155800

Other Study ID Numbers:

Sense-005

First Posted:

Dec 14, 2021

Last Update Posted:

Dec 14, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Wounds and Injuries

Study Results

No Results Posted as of Dec 14, 2021