Clinical trial NCT05155800: A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Lead sponsor: Sense Diagnostics, LLC
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 75
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compare ICH in TBI patients to non-ICH control subjects
timeFrame: up to 12 months
measure: Measure growth of intracranial hemorrhage
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady
state: Georgia
city: Cincinnati
country: United States
facility: UC Health
state: Ohio
Study officials:
affiliation: Emory University
name: Jonathan Ratcliff, MD
role: PRINCIPAL_INVESTIGATOR
References: