Trial Outcomes & Findings for A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage (NCT NCT03038087)

NCT ID: NCT03038087

Last Updated: 2021-12-07

Results Overview

Number of subjects who experienced a serious device-related adverse event or seizure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Up to 6 Weeks
• Results posted on: 2021-12-07

Participant Flow

Participant milestones

Measure	SENSE Device Monitoring in ICH Patients The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts: 1. A molded plastic headpiece containing the antenna array, and 2. A processing control unit that contains: 1. The driving electronics for the array; 2. A spectrum analyzer coupled with a computer; and, 3. The operating software that controls the device function and data acquisition, processing and archiving. For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam. The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

SENSE Device Monitoring in ICH Patients The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts: 1. A molded plastic headpiece containing the antenna array, and 2. A processing control unit that contains: 1. The driving electronics for the array; 2. A spectrum analyzer coupled with a computer; and, 3. The operating software that controls the device function and data acquisition, processing and archiving. For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam. The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.

Overall Study lost data

1

Baseline Characteristics

A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage

Baseline characteristics by cohort

Measure	SENSE Device Monitoring in ICH Patients n=10 Participants The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts: 1. A molded plastic headpiece containing the antenna array, and 2. A processing control unit that contains: 1. The driving electronics for the array; 2. A spectrum analyzer coupled with a computer; and, 3. The operating software that controls the device function and data acquisition, processing and archiving. For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam. The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 Weeks

Number of subjects who experienced a serious device-related adverse event or seizure.

Outcome measures

Measure	Subjects Who Experienced Serious Device-related Adverse Events or Seizure. n=10 Participants The number of subjects who experienced a device related serious AE and/or seizures will be tabulated and summarized.
Number of Patients With Serious Device-related Adverse Events	0 Participants

PRIMARY outcome

Timeframe: 12 Hours

Population: Study subjects were drawn from patients suffering from ICH. These patients either presented or transferred to a large, urban, comprehensive stroke center.

The SENSE device continuously monitored patients for hemorrhage expansion (HE) defined as a greater than 3 ml increase in ICH volume. ICH volumes were determined from the CT scans by a neuroradiologist. The concordance of SENSE determination of HE or NHE with the CT results was determined.

Outcome measures

Measure	Subjects Who Experienced Serious Device-related Adverse Events or Seizure. n=9 Participants The number of subjects who experienced a device related serious AE and/or seizures will be tabulated and summarized.
Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours. ICH Subjects with expansion	2 Participants
Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours. ICH Patients without expansion	7 Participants

SECONDARY outcome

Timeframe: Up to 72 Hours

Population: Patients were monitored with SENSE for an average of 60 (range: 23-72) hours. There were no serious adverse events. Minor adverse events were predominantly minor skin and nose irritation from the nosepiece of the headset. 1 Patient did not finish the study.

Number of patients where data was successfully acquired, downloaded, and analyzed.

Outcome measures

Measure	Subjects Who Experienced Serious Device-related Adverse Events or Seizure. n=10 Participants The number of subjects who experienced a device related serious AE and/or seizures will be tabulated and summarized.
Feasibility of the SENSE Device in a Clinical Environment	9 Participants

Adverse Events

SENSE Device Monitoring in ICH Patients

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SENSE Device Monitoring in ICH Patients n=10 participants at risk The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts: 1. A molded plastic headpiece containing the antenna array, and 2. A processing control unit that contains: 1. The driving electronics for the array; 2. A spectrum analyzer coupled with a computer; and, 3. The operating software that controls the device function and data acquisition, processing and archiving. For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam. The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.
Skin and subcutaneous tissue disorders Skin irritation	30.0% 3/10 • Number of events 3 • 6 months
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • 6 months

Additional Information

Joe Korfhagen

SENSE Diagnostics, Inc.

Phone: 844-373-6730

Email: jkorfhagen@senseneuro.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place