An Evaluation of a Non-invasive Brain Monitor (NCT02775136) | Clinical Trial Compass
UnknownNot Applicable
An Evaluation of a Non-invasive Brain Monitor
Germany160 participantsStarted 2014-10
Plain-language summary
HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians. Investigators hypothesis that the HS-1000 is capable of detecting and monitoring various neuropathologies, using the acoustic raw data derived from the noninvasive procedure.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult men and women subjects, aged 18 years old and over at screening visit
. Subjects with neuropathology that the principal investigator considers including in this study.
. Survival expectancy greater than 72 hours
. Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
. Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study
Exclusion criteria
. Local ear infection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of recordings that correlate to neuropathology
. Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
. For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
. Subarachnoid hemorrhage (SAH), Fisher Grade 4
. Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
. Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)