Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Behaviors and Mental Disorders

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Diabetes Mellitus

Depressive Disorder

Mental Disorders

Alzheimer Disease

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Depressive Disorder, Major

Depression

Heart Failure

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Lung Diseases

Cerebrovascular Disorders

Psychotic Disorders

Heart Diseases

Dementia

Brain Diseases

Central Nervous System Diseases

Tauopathies

Neurodegenerative Diseases

Neurocognitive Disorders

Respiratory Tract Diseases

Ischemia

Arteriosclerosis

Arterial Occlusive Diseases

Vascular Diseases

Chronic Disease

Disease Attributes

Schizophrenia

Schizophrenia Spectrum and Other Psychotic Disorders

Familial Alzheimer Disease

Chronic Graft Versus Host Disease

Care coordination, consisting variously (depending on the demonstration site)--nurse telephonic counseling, nurse in-person home visits, home telemonitoring equipment, and physician education and feedback.

Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers

Depending on the demonstration site, may consist of nurse telephonic counseling and monitoring, nurse in-person or home visits, home telemonitoring equipment, patient educational materials, patient group educations classes, physician education and feedback.

Care Coordination

Randall S. Brown, Ph.D.

Carol A. Magee, Ph.D.

This is a Congressionally mandated study. In the original study, 16 demonstration programs provided care coordination services to beneficiaries with chronic illness in Medicare's fee-for-service program. A five-year CMS-funded study tested whether the programs can improve patients' use of medical services, improve patients' outcomes and satisfaction with care, and reduce Medicare costs. The study also assessed physicians' satisfaction with the programs.

In 2008 Congress extended the project for two of the original programs--Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare beneficiaries and provide care coordination services into the spring of 2010.

Mathematica Policy Research, Inc. (MPR) evaluated 16 independent demonstration sites that provide coordinated care interventions to Medicare beneficiaries with chronic illnesses. The rationale for the demonstration is the lack of coordination among the multiple providers typically serving Medicare beneficiaries with chronic illnesses, as well as the adverse consequences of the lack of coordination for the beneficiaries and for Medicare costs. The demonstration sites, selected in early 2001, offered programs designed to improve both the care that patients receive and patients' knowledge of, and adherence with, recommended self-care and behavior. The study estimated the effects of each site on patients' well-being and satisfaction, in addition to the site's effects on the use and cost of Medicare covered services. This analysis relied on a patient survey conducted 6 to 12 months after enrollment, and on Medicare claims data and any data available from the demonstration sites that could enhance the study. The study included two rounds of physician surveys. In each site, eligible applicants were randomly assigned to treatment and control groups. An extensive process analysis was conducted to describe the interventions in detail, with the key goal being an assessment of those factors that account for program success and failure. The study included case studies of each site, program profiles, interim site-specific memos, two interim summary reports, two reports to Congress (based on the interim summary reports), and a final summary report. This original study enrolled 18,277 beneficiaries.

In 2008 Congress extended the study for 2 of the sites, Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania, and they will recruit beneficiaries and provide demonstration intervention services through the spring of 2010. Mathematica Policy Research will evaluate the results of this extended demonstration using Medicare claims data and qualitative site visits to the two programs.

Evaluation of Programs of Coordinated Care and Disease Management

Centers for Medicare and Medicaid Services

Mathematica Policy Research, Inc.

Wounds and Injuries

Neoplasms

Immune System Diseases

Eye Diseases

Skin and Connective Tissue Diseases

Parkinson Disease

Lewy Body Disease

Spinal Cord Injuries

Paralysis

Myasthenia Gravis

Atrophy

Tremor

Essential Tremor

Supranuclear Palsy, Progressive

Multiple System Atrophy

Shy-Drager Syndrome

Syndrome

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Movement Disorders

Synucleinopathies

Spinal Cord Diseases

Trauma, Nervous System

Neurologic Manifestations

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neuromuscular Junction Diseases

Neuromuscular Diseases

Autonomic Nervous System Diseases

Primary Dysautonomias

Hypotension

Ophthalmoplegia

Ocular Motility Disorders

Cranial Nerve Diseases

Progressive Supranuclear Palsy

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Phenylethyl Alcohol

Non-smokers, ages 18-80, diagnosed with Parkinson's Disease. Must be Hoehn and Yahr stage 2 or less with a history of motor symptoms less than two years.

Non-smokers, ages 18-80, diagnosed with Alzheimer's Disease. Must meet the 2011 National Institute on Aging-Alzheimer's Association and the 1984 National Institute for Neurological and Communicative Disorders and Stroke-Alzheimer's disease and Related Disorders Association criteria for probable AD.

Non-smokers, ages 18-80, diagnosed with Progressive Supranuclear Palsy. Must meet the NINDS-SPSP criteria for probable PSP, which requires vertical supranuclear gaze palsy, prominent postural instability, and falls in the first year of onset, as well as a number of other clinical features.

Non-smokers, ages 18-80, diagnosed with Essential Tremor.

Non-smokers, ages 18-80, diagnosed with Drug-Induced Parkinson's Disease.

Non-smokers, ages 18-80, diagnosed with Myasthenia Gravis.

Non-smokers, ages 18-80, who have been diagnosed with Multiple System Atrophy.

Non-smokers, ages 18-80, diagnosed with Diffuse Lewy Body Disease. Must meet the Consensus Criteria for the clinical diagnosis of DLBD.

Non-smokers, ages 18-80, with no neurodegenerative disease, and no first-degree relatives with a neurodegenerative disease.

Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG). The subjects will recline with their eyes gently closed. Sticky electrodes will be placed to the left and below the left eye. 6 different facial regions will be stimulated. The electrical stimulation will be kept constant during the test sessions. To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec. Four 0.2 msec pulses will be presented. In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec. 4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.

Electrical Brainstem Responses

Olfactory testing will be performed using standard tests. The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format. The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol. Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test. This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.

Olfactory Tests

During a 2-hour visual deprivation period, subjects will wear comfortable light-tight goggles with lenses that have been blackened by flat black paint. Subjects will be given the opportunity to recline comfortable in a padded reclining chair during this time.

Visual Deprivation

Electrical stimulation will be applied to a nerve of your arm. Sticky electrode pads will also be placed on a hand muscle. You will receive electrical stimulations that lasts less than a second. The stimulations will make your muscle twitch.

Peripheral Nerve Stimulation

Richard L Doty, PhD

This study seeks to establish the sensitivity and specificity of what appears to be a unique brainstem biomarker of Parkinson's Disease (PD) - an electrically induced olygosynaptic nasotrigeminal reflex response - in differentiating early stage PD from normal controls and from patients with various other neurodegenerative diseases. This study will additionally compare the biomarker to olfactory testing.

Parkinson's disease (PD), a devastating age-related disease that is clinically defined by its effects on the motor system, afflicts more than six million people worldwide, imposing enormous burdens on patients, relatives, caretakers, and society in general. Diagnostic errors are common, particularly as symptoms first arise. The most common misdiagnoses are Alzheimer's disease (AD), essential tremor, and vascular pseudo-Parkinson's Disease. An accurate diagnosis is typically made at a later stage of the disease when marked and irreversible damage has occurred within the motor control system of the brain. Sensitive and specific biomarkers of the early stages of PD are urgently needed. Identification of such markers is critical for the development and assessment of medications and other interventions designed to eliminate or reduce the gradual and irreversible decline of neurons involved in the disorder. This study seeks to establish the sensitivity and specificity of what appears to be a unique brainstem biomarker of PD - an electrically induced trigeminal nerve blink reflex response - in differentiation of early stage PD from normal controls and such neurodegenerative diseases as early stage AD, progressive supranuclear palsy (PSP), and diffuse Lewy Body disease (DLBD). This study will additionally compare the biomarker to olfactory test results.

Biomarkers in Neural Disorders

Latency, amplitude, and area under the curve of electrical brainstem reflex response of trigeminal nerve branches measured on the face musculature (before and after short-term visual deprivation).

The number of correct odor identification responses out of 40 from the standardized University of Pennsylvania Smell Identification Test (before and after short-term visual deprivation).

The number of correct responses in picking out an odor previously presented from three foils 10, 30, and 60 sec later using the standardized Odor Detection/Discrimination Test (before and after short-term visual deprivation).

The average of 7 reversals in a staircase odor detection threshold test that employs phenyl ethyl alcohol (rose oil) concentrations ranging from -7 to -2 log dilutions in light mineral oil.

Michael J. Fox Foundation for Parkinson's Research

University of Pennsylvania

Sclerosis

Multiple Sclerosis

Brain Injuries

Brain Injuries, Traumatic

Demyelinating Autoimmune Diseases, CNS

Demyelinating Diseases

Craniocerebral Trauma

All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.

Magnetic Resonance Imaging

Brenda Bartnik Olson, PhD

This study will test a new MRI sequence that measures cerebral blood flow (CBF). Because this technique for measuring CBF is new, there is little information on what the normal values for different regions of the brain should be. Information from the study will be used to establish normative CBF values for the brain, improving the reliable use of this technique for the diagnosis of brain injury or disease.

Cerebral blood flow (CBF) represents an important physiological parameter for the diagnosis and management of multiple brain disorders. The clinical need for CBF measurements is further complicated by the desire to have a non-invasive method with high temporal resolution that can measure CBF over a wide range of blood flows and in a wide range of patients. Numerous techniques are available to measure CBF. Nuclear medicine approaches, such as single positron emission computed tomography (SPECT) and positron emission tomography (PET) rely on radioisotopes which can be problematic in the pediatric population. In contrast, MRI-based methods are non-invasive and the CBF information can be obtained in conjunction with other MRI techniques (i.e. diffusion weighted imaging or spectroscopy) which allows for a combined longitudinal assessment of CBF, morphology, and metabolism, to provide a more complete understanding of the developing pathophysiological mechanisms.

Arterial spin labeling (ASL) perfusion imaging uses arterial blood water as an endogenous diffusible tracer where radiofrequency (RF) pulses magnetically label the moving spins in flowing blood without the use of a contrast agent. After a time delay allowing for the magnetically labeled blow to flow into the brain, "labeled" images are acquired. Separate control images are also acquired, without labeling and the difference between the two sets of imaged provides a measure of perfusion. Since gadolinium-based contrast agents are not required, the ASL perfusion technique is completely non-invasive. In addition, ASL techniques are insensitive to blood-brain barrier permeability changes, which can occur after strokes or with tumors.

Because gadolinium-based contrast is not used, the ASL technique has an inherently lower sensitivity than DSC-PWI. To date, there are a number of commercially available ASL techniques that differ in their labeling schemes, which has contributed to the difficulty in obtaining consistent results across different patient populations (pediatric, elderly, stroke, tumors). A number of recent reports using pseudo-continuous ASL (pCASL) have been published and show increased reliability across different patient populations. Moreover, a recent consensus statement published by the International Society of Magnetic Resonance in Medicine Perfusion Study Group recommends the use of pCASL labeling strategies for clinical applications.

The objectives of this study is to determine the accuracy and reliability of a newly developed pCASL sequence and post-processing software across multiple patient populations (neonate to elderly) and pathological processes.

Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging

The relative cerebral blood flow (CBF) in frontal, parietal, occipital gray matter and white matter regions, basal ganglia, thalami, and cerebellum will be measured using region of interest analysis to determine institutional normative values for healthy subjects.

Loma Linda University

Associate Proffesor

Magnetic Resonance Imaging.

Magnetic Resonance Imaging: All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.

Magentic Resonance Imaging

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Brenda Bartnik Olson

Regional Cerebral Blood Flow Values of the Brain Measured Using Pseudo-continuous Arterial Spin Labeling (pCASL) MRI.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Programs of Coordinated Care and Disease Management	NCT00627029	Congestive Hear... Diabetes Coronary Artery... Chronic Obstruc... Cancer Cerebrovascular... Alzheimer's Dis... Psychotic Disor... Major Depressio...	Care Coordinati...	-	Mathematica Policy Research, Inc.
Evaluation of Programs of Coordinated Care and Disease Management	NCT00627029	Congestive Hear... Diabetes Coronary Artery... Chronic Obstruc... Cancer Cerebrovascular... Alzheimer's Dis... Psychotic Disor... Major Depressio...	Care Coordinati...	-	Mathematica Policy Research, Inc.
Biomarkers in Neural Disorders	NCT02761707	Parkinson's Dis... Alzheimer's Dis... Progressive Sup... Essential Tremo... Multiple System... Drug Induced Pa... Diffuse Lewy Bo... Myasthenia Grav... Spinal Cord Inj...	Electrical Brai... Olfactory Tests Visual Deprivat... Peripheral Nerv...	18 Years - 80 Years	University of Pennsylvania
Evaluation of Programs of Coordinated Care and Disease Management	NCT00627029	Congestive Hear... Diabetes Coronary Artery... Chronic Obstruc... Cancer Cerebrovascular... Alzheimer's Dis... Psychotic Disor... Major Depressio...	Care Coordinati...	-	Mathematica Policy Research, Inc.
Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging	NCT02767609	Traumatic Brain... Multiple Sclero... Alzheimer's Dis... Tumor	Magnetic Resona...	18 Years - 90 Years	Loma Linda University
Patient-Centred Innovations for Persons With Multimorbidity - Quebec	NCT02789800	Hypertension Depression Anxiety Musculoskeletal... Arthritis Rheumatoid Arth... Osteoporosis Chronic Obstruc... Asthma Chronic Bronchi... Cardiovascular ... Heart Failure Stroke Transient Ische... Ulcer Gastroesophagea... Irritable Bowel Crohn's Disease Ulcerative Coli... Diverticulosis Chronic Hepatit... Diabetes Thyroid Disorde... Cancer Kidney Disease Urinary Tract P... Dementia Alzheimer's Dis... Hyperlipidemia HIV	DIMAC02	18 Years - 80 Years	Université de Sherbrooke

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