An Evaluation of Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm

Status unconfirmed · Not applicable

Conditions studied: Vasospasm, Intracranial, Subarachnoid Hemorrhage

In brief

HeadSense (HS)-1000 device, a proprietary 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. The investigators hypothesize that the HS-1000 is capable of detecting vasospasm using the raw acoustic data derived from the noninvasive procedure.

Key facts

Study ID

NCT02704637

Run by

HeadSense Medical

People needed

25

Starts

2017-05-01

Expected to finish

2018-12-01

Last updated by the study team

2019-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult men and women at least 18 years of age inclusive at the time of hospital admission for stabilization and treatment of the SAH
• Subjects receiving intensive care neurological monitoring per standard care following treatment of SAH
• Subject or legal authorized representative is able and willing to comply with the requirements of the protocol
• Subject or legal authorized representative is able to understand and sign written informed consent to participate in the study
• Subject is expected to undergo standard care neurological intensive monitoring for a maximum of 14 days
• Confirmed presence of a ruptured saccular aneurysm on angiography (catheter or CTA) and treated by neurosurgical clipping or endovascular coiling.
• Patient must have a modified Fisher of II to IV.
• The SAH should be between grades I-IV as defined by the World Federation of Neurological Surgery (WFNS).

You may not qualify if…

• Subject with ear disease, ear trauma
• Subjects with dural defects, punctures
• Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure
• Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea)
• Reported allergy or hypersensitivity to any of the test materials or contraindication to test materials
• 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)
• Patients who have a modified Fisher of 0 to I
• Patients who have a WFNS of V
• Presence of an intraventricular or intracerebral hemorrhage in absence of SAH or with only local, thin SAH
• Angiographic vasospasm prior to aneurysm repair procedure, as documented by catheter angiogram or CTA

Where it is running

• University of Maryland Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.