Trial Outcomes & Findings for Concussion Testing: A Novel Non-invasive Concussion Detection Device (NCT NCT02370914)

Results Overview

Sensitivity (also called the true positive rate) measures the proportion of concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data. Specificity (also called the true negative rate) measures the proportion of non-concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data The information that is evaluated from within this data is recognized through the computation of two parameters, R1 and R2. Both R1 and R2 are measured by computing the frequency spectrum using an FFT of the Neurowave data and computing a ratio of the signal intensities at specific higher frequencies against specific lower frequencies within that spectrum. Based on this computation, the recorded data is evaluated as coming from a concussed participant if R1 \>= 1.0 and R2 \>= 0.66 and is considered non-concussed otherwise.

Recruitment status

COMPLETED

Target enrollment

84 participants

Primary outcome timeframe

Individual assessments were made within 2 days of recording

Results posted on

2022-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic Device - Nautilus NeuroWave Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm . Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device
Overall Study STARTED	84
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Diagnostic Device - Nautilus NeuroWave Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm . Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device
Overall Study Protocol Violation	2

Baseline Characteristics

Concussion Testing: A Novel Non-invasive Concussion Detection Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic Device - Nautilus NeuroWave n=82 Participants Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm . Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device
Age, Categorical <=18 years	80 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.3 years STANDARD_DEVIATION 1.33 • n=5 Participants
Sex/Gender, Customized Males	82 participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants
Sport Concussion Assessment Tool- Second Edition (SCAT 2)	82.5 units on a scale STANDARD_DEVIATION 10.2 • n=5 Participants

PRIMARY outcome

Timeframe: Individual assessments were made within 2 days of recording

Population: Analysis population includes all participants. Some of these participants were were declared concussed by the physician in the team during the course of the season. All baseline recordings were treated as from non-concussed participants.

Sensitivity (also called the true positive rate) measures the proportion of concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data. Specificity (also called the true negative rate) measures the proportion of non-concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data The information that is evaluated from within this data is recognized through the computation of two parameters, R1 and R2. Both R1 and R2 are measured by computing the frequency spectrum using an FFT of the Neurowave data and computing a ratio of the signal intensities at specific higher frequencies against specific lower frequencies within that spectrum. Based on this computation, the recorded data is evaluated as coming from a concussed participant if R1 \>= 1.0 and R2 \>= 0.66 and is considered non-concussed otherwise.

Outcome measures

Outcome measures
Measure	Diagnostic Device - Nautilus NeuroWave n=82 Participants Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm . Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device
A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data Sensitivity	77 percentage of participants Interval 50.0 to 92.0
A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data Specificity	87 percentage of participants Interval 78.0 to 93.0

Adverse Events

Diagnostic Device - Nautilus NeuroWave

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Auerbach

Stanford University

Phone: (650) 725-9445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place