Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

This cohort will include patients having been diagnosed with a neurological condition.

This cohort will include patients who have not been diagnosed with a neurological disorder.

Amanda Wilburn

Shashaanka Ashili, PhD

Feng Lin, MD PhD

The purpose of this study is to collect clinical data, biological specimens (e.g., blood, tumor, cerebrospinal fluid, urine sample, etc.), and digital health data from patients with tumors, cancer and/or neurological disorders in order to perform research studies that could advance patient care. By collecting these specimens, the investigators plan to create and maintain a biorepository to make data and specimens available to collaborating investigators performing research to discover predictive biomarkers, patterns of care, and personalized treatments that could directly improve the care of our patients through focused proof-of-concept clinical trials.

For brain tumors in particular, this study will provide an important historical dataset against which to compare the addition of novel agents to standard chemoradiation. Despite advancements in surgery, radiotherapy and chemotherapy, the prognosis of malignant gliomas remains poor. Even worse is the prognosis of patients with metastatic brain tumors. However, it is recognized that a small number of brain tumor patients respond durably to specific modalities and treatment regimens and discovery of clinical, imaging, and genetic biomarkers would significantly advance the care of these patients. The development, validation, and application of prognostic biomarkers for primary and secondary brain tumors that predict patient treatment outcome and guide personalized treatment for each patient are of considerable clinical importance. Such prognostic models will allow more informed, pre-treatment decisions about patient response to specific treatments and judiciously guide stratification of patients for specific treatments and enrollment into clinical trials. Prognostic models will also provide a guide and platform for studying many other types of cancer and neurological disorders.

The significance of evaluating the impact of therapy on quality of life and patient-centered outcomes is now widely acknowledged and recognized as one of several measures used to determine clinical benefit. There is increasing evidence that patient reported outcome (PRO) measures are sensitive to changes in disease and treatment characteristics. For example, more recent clinical trials for cancer are now describing the relationship between symptom-based PRO measures and traditional clinical trial endpoints (e.g., overall survival (OS) and progression free survival (PFS)). The relationships between symptoms, signs, and functions are complex, and there is a need to continue to analyze these relationships to determine what is being caused by the treatment and what is being caused by the disease.

Distinguishing outcomes of normal aging from disease is also a challenge, therefore comparing results from patients without neurological disorders ("normal controls") across the spectrum will be an important component of the study.

Samples will be collected leftover from clinical care procedures. These sample types may include: tissue, blood, CSF, fluids, urine, saliva, etc.

Wearable Devices and Biomarkers Project (Healthiomics)

Study of Clinical Biomarkers in Human Health and Disease (Healthiomics)

To collect and store biological specimens (such as, but not limited to, tissue, blood, urine, cerebrospinal fluid, etc.), data from functional and anatomical imaging modalities, digital health data and clinical data from patients with cancer or neurological disorders, those who are under evaluation for a possible cancer or neurologic disorders, or healthy controls.

To perform multi-modality analysis of specimens for biomarker discovery.

To make specimens and data available to collaborating investigators performing IRB-approved research of cancer or neurological disorders.

CureScience

Heart and Blood Diseases

Stroke

A 250 ml feeding pouch containing 400 kcal.

Following the 7-day baseline period, all patients will enter the 28-day intervention period, where they will receive the intervention feed daily. The feed prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management

Bolus Pouch Feed

Rebecca Stratton, PhD

The primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. Secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.

Bolus enteral tube feeding (termed 'bolus feeding') is an increasingly common method of providing nutritional support to home enterally tube fed (HETF) patients, particularly those who are more active and/or require greater flexibility in their feeding regimen. However, current methods of bolus feeding are complex to administer, messy, may be unhygienic, and require and lead to a significant amount of plastic waste. Therefore, there is a clear need for a simpler and optimised way to provide bolus feeds. The aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life, ease of use, liking, compliance, gastrointestinal tolerance, nutritional intake, anthropometry and safety. This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.

This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.

Bolus Pouch Feed Study

A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults

At baseline, and at the mid-point and end of the intervention period, health and feeding related quality of life will be assessed by the FACT-EQ questionnaire.

At baseline, and at the mid-point and end of the intervention period, patients and dietitians will be asked to rate the ease of administering the enteral tube feed via a Likert-style questionnaire. Patients will also count the amount of feeding equipment required to administer the enteral feed at baseline, and at the midpoint and end of the intervention period.

At baseline, and at the mid-point and end of the intervention period, patients will be asked to rate their liking of their usual feeding method or of the intervention feed, respectively via a 7-point Likert scale questionnaire.

A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded at the end of each week. Information about bowel movements will also be collected using the Bristol Stool Chart©.

Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the patient.

At baseline, and at the mid-point and end of the intervention period, the dietitian will conduct a 24-h dietary recall with the patient to record all food, drink and nutritional feeds provided in the 24 h prior. Trained research staff will subsequently analyse all records utilising a nutritional software package (Nutritics Professional v3.09, Nutritics, Ireland) for macro- and micro-nutrient intakes.

At baseline and at the end of the intervention period, body weight (kg) will be measured using standard methods to the nearest 0.1 kg using a weighing scale without heavy clothing.

All adverse events will be recorded throughout the study.

Nutricia UK Ltd

Infections

Symptoms and General Pathology

Rare Diseases

Headache

Communicable Diseases

Pain

Central Nervous System Infections

Post-Dural Puncture Headache

Pseudotumor Cerebri

Neurologic Manifestations

Neoplasm Metastasis

Headache Disorders

Headache Disorders, Secondary

Hypertension

Intracranial Hypertension

Idiopathic Intracranial Hypertension

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.

Palpation used to identify and mark an insertion site.

VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.

Tactile Imaging (VerTouch)

Control, palpation used to identify and mark an insertion site.

Control (palpation)

This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.

Neuraxial procedures, in which a needle is inserted into the spinal canal through a gap in the vertebrae, are performed at a rate of nearly 13 million per year in the US, across a myriad of diagnostic and therapeutic clinical scenarios.

The standard of care involves manual palpation of the patient's back to detect the spinous processes (SPs) and estimate the location of the interspinous needle insertion site. While providers are trained to perform these procedures with meticulous precision and attention to detail, this technique remains highly inaccurate, often requiring multiple insertion attempts to properly place the needle. These attempts lead to patient pain and complications, such as traumatic taps and post-dural puncture (PDPH) headaches; unpredictable procedure times; and poor facility throughput.

The VerTouch device uses tactile imaging to offer a non-invasive, untethered, non radiation-producing solution for visualizing spinal anatomy in order to identify an ideal location for needle placement in a neuraxial procedure. The device can be used to mark the identified site with a surgical marker, or to begin placement of a needle or introducer at that site.

Study participants will be recruited in two parallel cohorts: the control (palpation) group or the tactile imaging (VerTouch) group, further stratified by procedure setting, including emergency medicine, neurology, and anesthesiology. Once an insertion site is marked with a marker or shallow placement of a needle or introducer, the procedure will continue in the usual manner for subjects in both groups.

An open-label, parallel, randomized study design

A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control

An Open-Label, Parallel, Randomized Study to Evaluate the Performance of Needle Placements for Diagnostic and Therapeutic Neuraxial Procedures, Using a Handheld Tactile Imaging-based Method Versus Palpation

Any forward movement of the needle following puncture of the skin, counted until confirmation of spinal canal access can be assessed.

A case that does not require any reinsertions, but can include any number of redirections.

Any forward movement of the needle in a new direction not preceded by withdrawal from the skin, counted until confirmation of spinal canal access can be assessed.

Any forward movement of the needle, calculated as the sum of insertions and redirections.

A case that does not require reinsertions or redirections.

Evaluated using a 10-point Numeric Pain Rating Scale, where 1 is equivalent to no pain and 10 is equivalent to the worst possible pain.

Evaluated using a 1-5 point Numeric Rating Scale where 1 is equivalent to not at all confident and 5 equivalent to completely confident.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Wearable Devices and Biomarkers Project (Healthiomics)	NCT05106725	Brain Cancer Neurological Di... Neurological Ca...		18 Years -	CureScience
Bolus Pouch Feed Study	NCT05822557	Cancer Neurological Di... Gastrointestina... Oral Complicati... Stroke	Bolus Pouch Fee...	16 Years - 100 Years	Nutricia UK Ltd
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control	NCT04796935	Central Nervous... Pseudotumor Cer... Neurological Di... Cancer Obstetric Proce... Orthopedic Proc... Post-Dural Punc...	Tactile Imaging... Control (palpat...	18 Years -	IntuiTap Medical, Inc
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control	NCT04796935	Central Nervous... Pseudotumor Cer... Neurological Di... Cancer Obstetric Proce... Orthopedic Proc... Post-Dural Punc...	Tactile Imaging... Control (palpat...	18 Years -	IntuiTap Medical, Inc
Wearable Devices and Biomarkers Project (Healthiomics)	NCT05106725	Brain Cancer Neurological Di... Neurological Ca...		18 Years -	CureScience
Bolus Pouch Feed Study	NCT05822557	Cancer Neurological Di... Gastrointestina... Oral Complicati... Stroke	Bolus Pouch Fee...	16 Years - 100 Years	Nutricia UK Ltd
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control	NCT04796935	Central Nervous... Pseudotumor Cer... Neurological Di... Cancer Obstetric Proce... Orthopedic Proc... Post-Dural Punc...	Tactile Imaging... Control (palpat...	18 Years -	IntuiTap Medical, Inc

Spots Global Cancer Trial Database for neurological disorder