An Evaluation of a Non-invasive Brain Monitor

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Adult men and women subjects, aged 18 years old and over at screening visit 2. Subjects with neuropathology that the principal investigator considers including in this study. 3. Survival expectancy greater than 72 hours 4. Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol 5. Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

Exclusion Criteria:

1. Local ear infection 2. Known allergy or hypersensitivity to any of the test materials or contraindication to test materials 3. For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding 4. Subarachnoid hemorrhage (SAH), Fisher Grade 4 5. 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) 6. 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02775136
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

HeadSense Medical
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Oliver Ganslandt, Prof.
Principal Investigator Affiliation Klinikum Stuttgart
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Injuries, Subarachnoid Hemorrhage, Vasospasm, Intracranial, Hydrocephalus, Brain Neoplasms
Additional Details

Non-invasive modality for brain monitoring can potentially serve as a major contribution to conventional monitoring techniques for patients with neuropathologies, to assure minimal discomfort to the bedbound patients, and provide information about critical physiological signs to the physicians. The lack of a precise diagnostic technique for numerous neuropathologies for patients in neurosurgical clinics can further hinder therapeutic effectiveness and, therefore, influence patient recovery and healing. Neuro-critical care involves monitoring standard vital signs and cerebral physiological signs, mainly focusing on intracranial pressure (ICP), temperature, cerebral blood flow velocity, arterial blood pressure, cerebral perfusion pressure, brain tissue oxygenation etc. The collaboration of state of the art brain monitoring vary between different intensive care units serves a significant drawback in some cases, as accuracy of diagnosis and monitoring is challenged and thereby there is an eminent need for interrelationship brain monitoring approach. That can also be leveraged by applying the monitoring noninvasively, as it particularly beneficial for clinical applications that routinely require the inevitable and dynamic transport of patients between hospital units (imaging, surgical room, etc.). Subjects who meet the inclusion and exclusion criteria for this study, with a signed informed consent form, will be enrolled into the study. Eligible patients will be divided to 2 groups: 1. Patients undergoing Invasive ICP monitoring 2. Subarachnoid hemorrhage (SAH) patients with Fisher Grade of 3 or 4 The non-invasive measurements recording sessions will be according to the protocol scheme per each group: 1. Eligible patients undergoing Invasive ICP monitoring will be monitored by the HS-1000, in parallel to the invasive ICP monitor, for a single recording session. 2. Eligible SAH patients with Fisher Grade of 3 or 4 will be monitored by the HS-1000, in parallel to the invasive ICP monitor, for three recording sessions. For all eligible patients, non-invasive measurements by the HS-1000 device will be conducted in parallel with the standard monitoring modalities, as used at the site without any change in the patient's management.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Klinikum Darmstadt, Darmstadt, Germany

Status

Recruiting

Address

Klinikum Darmstadt

Darmstadt, , 64283

Site Contact

Rainer Kollmar, Prof.

Rainer.Kollmar@mail.klinikum-darmstadt.de

06151 - 107 4501

University Hospital Erlangen, Erlangen, Germany

Status

Recruiting

Address

University Hospital Erlangen

Erlangen, ,

Site Contact

Rudolf Rammensee

rudolf.rammensee@uk-erlangen.de

09131 85-33001

Universitätsklinik Göttingen, Gottingen, Germany

Status

Recruiting

Address

Universitätsklinik Göttingen

Gottingen, , 37075

Site Contact

Christian von der Brelie, Dr.

cvdb@gmx.net

410-245-9782

Klinikum Stuttgart, Stuttgart, Germany

Status

Recruiting

Address

Klinikum Stuttgart

Stuttgart, ,

Site Contact

Oliver Ganslandt, Prof.

o.ganslandt@klinikum-stuttgart.de

0711 278-33700

Stay Informed & Connected