Symptoms and General Pathology

All Conditions

Nervous System Diseases

Heart and Blood Diseases

Neoplasms

Skin and Connective Tissue Diseases

Hemorrhage

Subarachnoid Hemorrhage

Ganglion Cysts

Neoplasm Metastasis

Emergencies

Synovial Cyst

Cysts

Vasospasm, Intracranial

Intracranial Hemorrhages

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Mucinoses

Connective Tissue Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Ropivacaine

Experimental patients will receive a stellate ganglion block with 0.25% ropivacaine 10mL on the same side of vasospasm at the level of the sixth cervical vertebrae (C6) before surgery.

Patients were then assessed using transcranial Doppler

patients will receive a stellate ganglion block with 0.9% saline 10mL on the same side of vasospasm at the level of the sixth cervical vertebrae (C6) before surgery.

Patients were then assessed using transcranial Doppler

Stellate ganglion block under ultra-guide will be administered using 0.25% ropivacaine 10mL

Stellate Ganglion Block

Stellate ganglion block under ultra-guide will be administered using 0.9% saline 10mL

Placebo

To investigate whether the stellate ganglion block is helpful in relieving cerebral vasospasm during aneurysmal coil embolism surgery. The effect was assessed by Transcranial Doppler (TCD).

Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

Effect of Stellate Ganglion Block on Cerebral Vasospasm in Patients With Emergency Aneurysmal Subarachnoid Hemorrhage

Beijing Tiantan Hospital

Vice Professor

Wounds and Injuries

Brain Injuries

Hydrocephalus

Brain Neoplasms

Craniocerebral Trauma

Trauma, Nervous System

Central Nervous System Neoplasms

Nervous System Neoplasms

Non-invasive measurements duration with HS-1000 device will be for at least 30 minutes and up to 1 hour of aggregate recording either continuously in the event the patient's clinical condition allows it or in separate recording iterations in the event patient's condition will not allow continuous recording. For each patient, there may be several monitoring intervals from three times a day and up to as long as the patient undergoes brain monitoring, per the discretion of the investigator, patient and/or family members.

HS-1000 recording

Thomas Swanson

Dana Hromyak

Rainer Kollmar, Prof.

Ilia Aroyo, Dr.

Rudolf Rammensee

Christian von der Brelie, Dr.

Oliver Ganslandt, Prof.

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.

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.

An Evaluation of a Non-invasive Brain Monitor

An Open-Label, Non-Randomized, Comparative Study Designed to Evaluate the Accuracy and Safety of HS-1000 Device, a Non-Invasive Brain Monitor

Demonstrate the HS-1000 performance and accuracy in brain monitoring

Klinikum Stuttgart

Klinikum Darmstadt

University Medical Center Goettingen

HeadSense Medical

All subjects enrolled on study will utilize Aqueduct's Smart External Drain (SED) from the time of external drain implementation until end of study upon discharge of SED or switch to standard of care external drain.

Aqueduct's Smart External Drain (SED) is a gravity based system which utilizes a proprietary reference shroud which eliminates the need for manual adjustment of the system in the external management of CSF drainage.

Smart External Drain - SED

Sam Browd, MD, PhD

Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for temporary CSF management in a hospital setting.

* Evaluate the number of subjects requiring to be switched to a standard of care EVD
* Evaluate subject transport while on the SED
* Evaluate SED system control from initiation of SED through discharge of external drain system

This clinical trial will evaluate Aqueduct's Smart External Drain (SED) upon implementation of ventriculostomy or lumbar drain placement for temporary CSF external management in a hospital setting. Subjects will remain on study from the time of SED application through discharge of the external drain or switch to standard of care extraventricular drain.

A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)

A Secondary Study Evaluating Performance and Safety of Aqueduct's Smart External Drain (SED2)

Evaluating the number of subjects which require switching to a standard of care external drain versus the number of subjects which remain on the SED until study completion or discharge of the external drain.

Evaluating subject transport while on the SED system, specifically, the number of minutes a subject will require clamping of the drain while being transported.

SED system control will be evaluated from initiation of ICP management through discharge of the subject's external drain.

Aqueduct Critical Care

Diseases and Abnormalities at or Before Birth

Aneurysm

Arteriovenous Malformations

Congenital Abnormalities

Intracranial Aneurysm

Hemangioma

Intracranial Arterial Diseases

Vascular Malformations

Cardiovascular Abnormalities

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Patients receiving surgical intervention for an intracranial arterial-venous malformation.

Patients receiving surgical intervention for a ruptured intracranial aneurysm.

Patients receiving surgical intervention for an unruptured intracranial aneurysm.

Eric M Deshaies, MD

Test single nucleotide polymorphisms (SNP's) in ruptured and unruptured aneurysm tissue to identify a genetic difference between the two types of aneurysms; and to test SNP's in arteriovenous malformation tissue to identify a genetic link.

Tissue samples of intracranial arterial-venous malformations (AVM) or aneurysm and blood samples.

Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm

The samples will be frozen after collection and then analyzed.

State University of New York - Upstate Medical University

Immune System Diseases

Infections

Rare Diseases

Encephalitis

Meningitis

Syndrome

Guillain-Barre Syndrome

Neuroinflammatory Diseases

Polyradiculoneuropathy

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Polyneuropathies

Peripheral Nervous System Diseases

Neuromuscular Diseases

Communicable Diseases

Post-Infectious Disorders

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Performing Lumbar Puncture assisted by LPat

Performing Lumbar Puncture utilizing LPat device

LPat Device

The purpose of this study is to proof and investigate the effectiveness and safety of the invented device named "Human Lumbar Puncture Assist Device (LPat)" as an assist tool to be utilized to improve the success rate of performing lumbar puncture (LP), avoid side effects from multiple punctures, avoid excess radiation if the LP need to be done under fluoroscopy, and need to obtain none traumatic tap for better CSF analysis.

"Human Lumbar Puncture Assist Device (LPat)" was invented as an assist tool to be utilized to improve the success rate of performing lumbar puncture (LP), avoid side effects from multiple punctures, avoid excess radiation.

The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)

Edward Via Virginia College of Osteopathic Medicine

Spartanburg Regional Healthcare System

Medical Director, PICU

Behaviors and Mental Disorders

Epilepsy

Epilepsy, Temporal Lobe

Brain Injuries, Traumatic

Hematoma

Unconsciousness

Coma

Arnold-Chiari Malformation

Infratentorial Neoplasms

Supratentorial Neoplasms

Spinal Dysraphism

Neural Tube Defects

Nervous System Malformations

Epilepsies, Partial

Epileptic Syndromes

Consciousness Disorders

Neurobehavioral Manifestations

Neurologic Manifestations

Chiari Malformation Type 2

Merve Tugba Ozfidan Donmez, MD

Ozlem Korkmaz Dilmen, MD

Yusuf Tunali, MD

Fatma Eren Akcil, MD

1. The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients.
2. The secondary objectives are to evaluate the impact of the FIVE score on hospital length of stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores

Consciousness monitoring is crucial in neuro-intensive care. Despite the use of different scoring systems to establish a common language among evaluators, the Glasgow Coma Scale (GCS) remains the most widely used in clinical practice. In GCS evaluation, verbal response, motor response, and eye response are assessed. Another scoring system, FOUR (Full Outline of UnResponsiveness ) Score is similar to the Glasgow Coma Score (GCS). But it is designed to provide a more comprehensive neurological assessment. The FOUR score evaluates four areas: including eye opening, motor response, brainstem reflexes, and respiration, and assigns a score for each area. A comprehensive education regarding those scores was given the intensive care healthcare providers before the trial.

In this study, the investigators developed the Full Intracranial Validity Evaluation (FIVE) Score, by adding the mean arterial pressure and gag reflex components to the FOUR score. The investigators believe that this new score, which can be used for clinical monitoring, may offer an alternative to FOUR and GCS monitoring. According to this scoring system, in addition to the criteria for the FOUR score, patients with a mean arterial pressure between 60-130mmHg receive 2 points; patients under inotropic support with a mean arterial pressure between 60-130mmHg receive 1 point; patients with a mean arterial pressure below 60mmHg or above 130mmHg receive 0 points. Additionally, for patients with infratentorial mass, the investigators add the assessment of gag reflex in the calculation of the FIVE score. If the reflex is absent, 0 points are given; if it is unilateral, 1 point is given, and if it is preserved, 2 points are given.

The demographic data, diagnoses, systemic comorbidities, the American Society of Anaesthesiologists (ASA) score, the Charlson Comorbidity Index (CCI), and the APACHE II scores of patients were recorded.

The GCS, FOUR, and FIVE scores of the patients were recorded at neuro ICU admission, every 12 hours during neuro ICU follow-up period and discharge. In our clinic, GCS monitoring is routinely performed hourly for every patient admitted to the ICU. For patients with a decrease of two or more points in GCS score, FOUR and FIVE scores were re-evaluated and recorded without waiting for the 12 hours. Besides this, the worst, the best and the mean GCS, FOUR, and FIVE scores were recorded in the neuro ICU follow-up period. The assessment count of the GCS, FOUR, and FIVE scores during clinical follow-up was recorded.

The length of ICU and hospital stay were recorded. The Modified Rankin Scale of the patients was recorded six months after ICU discharge.

The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients. The secondary objectives are to evaluate the impact of the FIVE score on length of hospital stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores.

A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score

The New Developed FIVE Score and Its Comparison With GCS and FOUR Scores Regarding Length of Hospital Stay Morbidity and Mortality in Neuro-intensive Care Patients. an Observational Prospective Study

Glasgow Coma Scale (GCS) and Four/Five Scores, along with the highest, lowest, and average scores, discharge scores, Modified Rankin Scores at 6 months post-discharge, and length of stay information measured upon admission to the intensive care unit will be shared.

Full Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation

Glasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation

In scoring post-discharge morbidity six months after intensive care unit discharge, Modified Rankin Score is used. minimum value:0, maximum value:6, higher scores mean a worse outcome

Istanbul University - Cerrahpasa (IUC)

medical doctor

Stroke

Ischemic Stroke

Ischemia

Cerebral Hemorrhage

Neurocritical patients including those sustaining head injury, cerebrovascular events (such as intracerebral hemorrhage, subarachnoid hemorrhage, etc.), brain tumor, or hydrocephalus.

Yi-Hsin Tsai, M.D.

The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial pressure (ICP) and clinical outcome of neurocritical patients.

Transcranial Doppler (TCD) and Transcranial color-coded duplex sonography (TCCS) play an important part in neurocritical monitoring systems. Currently there are studies using flow velocities and pulsatility index (PI) to predict intracranial pressure (ICP) and clinical outcome. But the use of B-mode in such prediction is not yet investigated. The purposes of this study are to establish the correlation among clinical data, CT findings and information collected by TCCS, and to predict ICP and neurological outcome using such information. The focus would be on 3rd ventricle size, midline shift and anteroposterior-transverse ration of midbrain (midbrain index) obtained by B-mode of TCCS. This study is a prospective clinical study targeting on 30 neurocritical patients admitted to intensive care units in one year. The timing of performance of TCCS will be (1) within 6 hours after admission, (2) within 6 hours after each CT examination, and (3) when ICP is higher than 20 mmHg for more than 5 minutes. Glasgow coma scale (GCS), heart rate, blood pressure (systolic, diastolic, and mean), body temperature, central venous pressure (CVP), brain temperature, ICP, cerebral perfusion pressure (CPP), mean velocity (MV) of bilateral middle cerebral arteries (MCAs), PI, midline shift, 3rd ventricular dimension, anteroposterior to transverse ratio of midbrain (midbrain index, MI) are recorded. The latter three parameters are also obtained from CT scans, and compared with those obtained from TCCS. Outcome is evaluated with extended Glasgow outcome scale (GOSE), and analyzed with previous records. This study is going to prove that TCCS is a safe, convenient, real-time and cheap tool in clinical care for neurocritical patients. It also provides prediction of ICP and clinical outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage	NCT04512859	Subarachnoid He... Cerebral Vasosp...	Stellate Gangli... Placebo	18 Years - 65 Years	Beijing Tiantan Hospital
An Evaluation of a Non-invasive Brain Monitor	NCT02775136	Brain Injuries Subarachnoid He... Vasospasm, Intr... Hydrocephalus Brain Neoplasms	HS-1000 recordi...	18 Years -	HeadSense Medical
A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)	NCT03471702	Hydrocephalus Hydrocephalus i... Tumor, Brain Subarachnoid He...	Smart External ...	- 80 Years	Aqueduct Critical Care
An Evaluation of a Non-invasive Brain Monitor	NCT02775136	Brain Injuries Subarachnoid He... Vasospasm, Intr... Hydrocephalus Brain Neoplasms	HS-1000 recordi...	18 Years -	HeadSense Medical
Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm	NCT01801488	Arteriovenous M... Intracranial An... Subarachnoid He...		18 Years - 89 Years	State University of New York - Upstate Medical University
The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)	NCT03710278	Meningitis Encephalitis Guillain-Barré Subarachnoid He... Intracranial Ne... Intracranial CN...	LPat Device	12 Years -	Spartanburg Regional Healthcare System
A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score	NCT06036732	Postoperative I... Postoperative I... Supratentorial ... Infratentorial ... Arnold Chiari M... Subarachnoid He... Traumatic Brain... Epilepsy, Tempo... Cerebrovascular... Intensive Care ... Coma Unconsciousness Assessment, Sel...		18 Years - 80 Years	Istanbul University - Cerrahpasa (IUC)
Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage	NCT04512859	Subarachnoid He... Cerebral Vasosp...	Stellate Gangli... Placebo	18 Years - 65 Years	Beijing Tiantan Hospital
The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients	NCT00886054	Head Injury Intracerebral H... Ischemic Stroke Subarachnoid He... Brain Tumor Hydrocephalus		16 Years - 80 Years	National Taiwan University Hospital

Spots Global Cancer Trial Database for subarachnoid hemorrhage