Vasospasm
Conditions
Keywords
Vasospasm, Aneurysm, SAH, Nautilus NeuroWave
Brief summary
To determine the efficacy of using the Jan Medical NNW system as a diagnostic aid in detection of moderate and severe vasospasm for detection of vasospasm in patients with subarachnoid hemorrhage.
Detailed description
This study is a prospective, comparative, non-randomized study in subjects with subarachnoid hemorrhage who are undergoing surveillance for vasospasm. The study will be conducted in one center. The primary objective of Phase I of this non-significant risk study is proof of principle. During this phase the goal is to build a library of Jan Medical NNW system recordings from patients with moderate and severe vasospasms. A signature for detecting vasospasms will be developed using the signals from a vasospasm epoch to a patient's individual baseline recording and confirming the presence of vasospasm by comparison of Jan Medical NNW system data to TCD and, when available Digital Subtraction Angiography (DSA). The number of patients required for Phase I is estimated to be 20 patients with confirmed moderate or severe vasospasm with a minimum of 10 these patients having at least one severe vasospasm recording confirmed by TCD or DSA. Daily recordings are to be taken. During Phase II the Jan Medical NNW system will independently utilize the signatures identified in Phase I to identify the presence or absence of moderate and severe vasospasm in a blinded recording. This recording will be compared to TCD or DSA, when DSA is available, for analysis of sensitivity and specificity. Up to 50 subjects will be enrolled in Phase II. When possible, multiple recordings will be obtained from each subject to include recordings with and without vasospasm. Duration of each subject's enrollment in this study is limited to the period of time when Jan Medical NNW system recordings are performed. No additional tests or procedures will be performed during participation in this study and all other data collected (including TCD or DSA) will be based on available evaluations conducted as part of the patient's standard of care. Upon completing the last Jan Medical NNW system recording or when no further data collection is expected, the subject will be exited from the study.
Interventions
DEVICENautilus NeuroWaveTM recording
Nautilus NeuroWaveTM recording 15 minute recording with Nautilus NeuroWave Neurodiagnostic .
Sponsors
Jan Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects 18 years of age or older. 2. Subjects with subarachnoid hemorrhage who are receiving clinical and diagnostic surveillance for vasospasm. 3. Signed informed consent from the patient or the patient's Legally Authorized Representative
Exclusion criteria
1. Unstable medical illness such that recordings might interfere with medical care. 2. Presence of head bandages or brain monitors that might physically interfere with the NNW recording device. 3. Current hemicraniectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity (moderate or severe) | Within 5 minutes from end of recording | Efficacy at identifying moderate or severe vasospasm. Reference diagnosis will be with TCD and where available DSA |
| Specificity | Within 5 minutes of recording | Rate of false positives using TCD and where available DSA as the reference standard. False positive is a recording judged mild or no vasospasm by TCD or DSA that is determined by the NNW as moderate or severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Location of vasospasm | Within 5 minutes of recording | With TCD and DSA, when available, as reference standards, the efficacy at locating any vasospasm as ocurring in the left, right or back of the cranium. The measure will be what % of correctly called vasospasm was correctly located. |
| Specificity | Within 5 minutes of end of recording | Rate of false positives using TCD and where available DSA as the reference standard. False positive is a recording determined as no vasospasm by TCD or DSA that is determined by the NNW as either mild, moderate or severe vasospasm |
| Sensitivity at detecting any vasospasm | Within 5 minutes of recording | Efficacy at identifying vasospasm either mild, moderate or severe. Reference standard will be TCD and DSA where available. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device related adverse events | Within 1 week of end of recording | The total number of adverse events reported by the clinical site |
| Ease of use | Within 5 minutes from end of recording | Number of recordings that were not of adequate quality for a determination. This will be a no call |
Countries
Germany
Outcome results
None listed