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Early Assessment and Resource Linkage for Youth
The primary goal of the EARLY Program is to identify and treat adolescents and young adults who are experiencing changes in their thoughts, behavior or emotions that might be associated with developing a psychotic illness.
The EARLY Program is based on previous studies conducted in the United Kingdom, Australia, the United States and Scandinavia that focused on interrupting the very early progression of schizophrenia and other psychotic disorders. These studies demonstrate that intervention may counteract the acute onset of major psychotic disorders.
EARLY consists of two major components:
• Treatment Program: EARLY is staffed by a multidisciplinary team led by Steven Adelsheim, M.D., with special training in the area of early identification and treatment of psychosis. Young people who are showing the warning signs of a psychotic illness and their families are offered services once the young person has met criteria for inclusion in the program.
• Brain Imaging and Genetics Program: Youth enrolled in the EARLY Program may also choose to be part of a brain imaging and genetics initiative led by Kent A. Kiehl, Ph.D. These initiatives use sophisticated techniques to pinpoint brain regions that may be overactive or underactive in individuals experiencing the early warning signs of psychosis, and to investigate possible links between genes and psychosis.
The importance of early intervention
Approximately 3% of the population will experience a psychotic disorder at some point in their life, with most serious mental illness having its onset during adolescence. Psychotic disorders can be devastating and debilitating for the individual and their family. However, early identification and intervention may prevent or delay the onset and decrease the severity of a serious mental illness. Specifically, early identification and treatment can result in:
• Preservation of psychosocial skills
• Maintenance of family and social supports
• Continuation of school and/or work
• More rapid recovery
• Possibility of a reduced need for medication
• Preservation of brain function
• Decreased need for hospitalization
What is psychosis?
Psychosis refers to changes in the brain that interfere with a person’s experience of their world. Psychotic illnesses include schizophrenia, bipolar disorder and major depression. Characteristic symptoms of psychosis are hallucinations, delusions, and confused thinking.
What is prodromal psychosis (pre-illness)?
The prodromal phase encompasses the period of early symptoms or changes in functioning which precede psychosis. It is the pre-illness period. Symptoms during this phase may be quite obvious or hardly noticeable and can occur over a matter of days or months. It is the combination of several symptoms, rather than any one symptom, that puts an individual at risk. Symptoms may include:
• Being fearful for no reason
• Having jumbled thoughts and confusion
• Heightened sensitivity to sights, sounds, touch or smells
• Feeling “something’s not quite right”
• Hearing sounds/voices that are not there
• Declining interest in people, activities and self care
• Trouble speaking or writing clearly
What services are provided by EARLY?
• EARLY provides confidential assessment, education, treatment and assistance for young people and their families, and conducts research about the benefits of early identification and intervention for psychosis.
• EARLY trains teachers, school professionals, health organizations and the general public about psychosis, early warning signs, and how to access services.
• EARLY works to educate professionals and the general public about stigma, preventing mental illness and best methods of treatment.
Who is eligible to participate?
To be eligible for EARLY, an individual must:
• be between the ages of 12 and 25 years;
• live within certain areas of Bernalillo County; and
• be having experiences that may be associated with the development of a psychotic illness.
There is also an opportunity for individuals between the ages of 12 and 25 years who are emotionally and physically healthy to serve as research controls for the EARLY Program brain imaging/genetics substudy.
Additional information
• Participation in all studies is strictly voluntary and can be discontinued at any time.
• Participants generally incur no cost for study procedures and will be reimbursed for their time.
EARLY Investigators
• Kent A. Kiehl, Ph.D., The Mind Research Network
• Steven Adelsheim, MD, The University of New Mexico, Center for Rural and Community Behavioral Health, Department of Psychiatry
For more information:
Call: 1-888-NM-EARLY (1-888-663-2759)
Email:
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Website: www.earlyprogram.org HRRC# 08-224 |
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Neuroinformatics is a hybrid field of neuroscience and computer science disciplines whose major goal is to produce databases and software for data acquisition, data management and data exploration (http://www.neurovia.umn.edu/IGERT). The hallmark of neuroinformatics software is that it helps investigators integrate all neuroscience research information sources collected within a research study--such as integration of genetic information with clinical assessments scales and brain morphometry measures. Neuroinformatics tools are targeted towards scientists that collect, summarize and use neuroscience research data in analyses so that these investigators can focus on understanding the function of the brain in healthy and disease populations rather than getting bogged down by data use and integration issues.
The Neuroinformatics Core (NIC) is located at the Mind Research Network (MRN) in Albuquerque. The MRN has extensive experience in the design, conduct and analysis of single and multi-centered clinical trials. This includes the MIND Clinical Imaging Consortium, which generates data from more than 400 human research volunteers across four sites (University of New Mexico, The University of Iowa, University of Minnesota, and Harvard University) that have had comprehensive neuroimaging (MR spectroscopy, fMRI, DTI, MEG), genetic, clinical, socio-demographic, and neuropsychological assessments. The neuroinformatics core is responsible for all aspects of data management for this project including data security, querying, reporting, analyzing, summarizing, and archiving. Other ongoing projects that the NIC participates in are the Biomedical Informatics Research Network (BIRN), as well as the National Alliance for Medical Imaging Computing (NA-MIC).
Organization
Mr. Jeremy Bockholt has had 16 years of experience in neuroscience research and software development and has lead neuroinformatics support and centralized morphometric analysis efforts at the MRN for the past four years. Mr. Bockholt is an experienced project manager, database manager, software engineer, and anatomical imaging analysis practioneer. Mr. Bockholt currently leads a team of software engineers at the MRN whose mission is to develop state of the art neuroinformatics tools. Mr Bockholt leads the NIC and oversees all aspects of data management from all project investigators. The NIC team will work with the study investigators to finalize the study data collection forms and build a computerized SQL database system. Having the NIC in the same location where the MR, MEG, EEG analysis occurs, in addition to where a statistician is located, facilitates communication and coordination of data related issues. In addition, the core directors and scientific director participate in semi-monthly meetings with Mr Bockholt to discuss issues related to the NIC (forms design, database development, database management, quality control procedures, recruitment issues, etc.). Minutes of the meetings, as well as data collection forms, recruitment reports, etc. will be posted to an intranet and will be available to all study investigators (password protected).
Data Core Specific Aims
1) finalizing the study protocol in collaboration with the study investigators, 2) collaborating with the study investigators in the development of the forms for recording data as well as 3) development of the method for transmission of data to the NIC, 4) collaboration with the study investigators in developing the detailed Manual of Procedures, 5) development of a web-based database, 6) managing the database, 7) running SAS quality-control program checks, 8) maintaining the Master Database with appropriate backups and security checks, 9) monitoring subject recruitment and distributing monthly enrollment reports, 10) producing reports summarizing the status of data acquisition by subject, distributions and summary statistics for the primary variables.
Additional NIC Activities
Further responsibilities of the NIC include: providing an organized network with a ³user friendly² interface, defining and building the public vs. secure (private) sections, providing public website features (including an overview of network and study information, background and responsibilities of key personnel, news items, conference information and announcements, information for potential study subjects), and providing secure website features (to include: access to the Manual of Procedures, reports to the steering committee and supporting foundations, minutes of conference calls with study investigators, reports and updates on recruitment status, reports to the Data Monitoring and Safety Committee.
System Information, Data Entry/Verification, and Quality Assurance
Multiple RDBMS database servers running Oracle 9i instances will be maintained to provide separate development, integration, and production environments. When necessary, the production environment can be rolled over to the integration environment such that data access down-time is  minimized during hardware maintenance or failure. At the same time, enhancements to the system are ongoing in the development environment, get thoroughly tested in the integration environment and are scheduled for migration into the production environment in a way that minimizes loss of data access. A middleware tier will be used to provide web applications to the end users using desktop web browsers over secure HTTP connections. Multiple web-application servers running PHP 4.3 and Apache 2.0 will be utilized to provide separate development, integration, and production environments. Thus permitting the same system development and maintenance cycle outlined in the RDBMS section above.
Quality Assurance
Any pen and paper assessments will be data-entered twice (by separate entry operators) and screened for entry errors. Study site coordinators can resolve entry conflicts and review logical errors made at the time of acquisition according to a data dictionary defining the type and range of each item relevant to the clinical instrument and protocol. A comprehensive data dictionary from previous studies that used similar clinical instruments will be used at the onset to develop a real-time quality assurance program for the study under review. To ensure maximal data quality, raters will be notified immediately when assessment values lie outside the ranges identified by the data dictionary for each item that is entered. Over the course of the study, the data dictionary will be optimized for the population being studied. Data will be checked for integrity and verification. An audit trail will be maintained when resolution of outliers lead to either a formal documented change in the data point or confirmation that the data point represents extreme but normal biological variation. An error report page (when errors occur) will be interactively returned to the user. The database will track who made the transaction and the time and date of the transaction for each successful data submission. Every successful submission of a transaction will be recorded in on-line archive tables, thus providing a complete audit trail of the database. That is, the database can be recreated to any point in time. Every six months, protocol review will be performed by relevant principal investigators to include audits of informed consent documentation and data accuracy. Reports will be prepared on the following elements: timeliness and completeness of data submission; eligibility and compliance; and accrual information.
Data and Safety Monitoring, Adverse Event Data Collection and Reporting
The MRN NI tools facilitate a Data and Safety Monitoring Plan, which monitors the well-being of study participants and ensures scientific integrity of the project can also. During the course of a study, adverse events can be immediately entered into the data base and communicated to site directors; any serious adverse events will be formally reported to the IRB within five days. A cumulative adverse event-reporting table can be completed for annual continuing review. A monthly report that includes a written description of any potential adverse events is also available. Monitoring criteria include: number of subjects screened, number of subjects enrolled, number of drop outs, any complaints or adverse events.
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The symptoms of Traumatic Brain Injury (TBI) can range from severe physical and mental disability to subtle problems with attention, concentration, or emotional control. Patients with TBI often have persisting, disabling cognitive and emotional problems that impact their work and family lives and limit their ability to seek appropriate care. The pathology underlying more moderate to severe TBI include lesions, contusions and hemorrhages that are readily diagnosed with conventional scanning methods such as magnetic resonance imaging (MRI); however, there may also be other pathology in healthy appearing tissue. Similarly, the identification of the pathology underlying mild TBI is often more subtle and complicated. TBI Resources TBI Research Team TBI Publications  In the United States alone there are approximately 1.2 million mild TBI cases per year that result in an estimated cost of $56 billion dollars. In the majority (60-70%) of these cases, clinical findings are absent on standard CT scans. Although MRI scans are more sensitive than CT for diagnosing mild TBI injuries such as small petechial lesions, approximately 43-68% of mild TBI cases have normal MRI scans. The fact that traditional imaging modalities may be insensitive to differences between normal and mild/moderate TBI in the majority of cases suggests that the diagnostic utility and predictive validity of more research-based neuroimaging techniques, such as functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS), magnetoencephalography (MEG) and diffusion tensor imaging (DTI) needs to be explored.
Nowhere is the problem of TBI more dramatic than with our returning veterans from Iraq and Afghanistan. Specifically, two-thirds suffer from brain injuries or mental health problems, a rate much higher than that seen in prior conflicts. In fact, mild TBI is the most common injury in returning veterans and may be undiagnosed or misdiagnosed as either post-traumatic stress disorder (PTSD), depression, or as an attention deficit disorder. The nature of the brain injuries in recently returning veterans is also different – blast injuries predominate over acceleration and deceleration injuries, which are much better understood. Importantly, for unknown reasons, soldiers injured in a blast are more likely to have symptoms of an acute stress reaction or PTSD in addition to a TBI. This combination of factors renders the differential diagnosis of PTSD and TBI extremely challenging for care providers.
The first step for successful treatment is to better understand the pathophysiology underlying TBI, and to develop biomarkers sensitive to neuronal injury and recovery. This ensures that best care practices will be used when diagnosing and treating patients with TBI. We are currently seeking to identify biomarkers in brain images that 1) improve the ability to differentiate TBI from other diagnoses, 2) correlate with measures of functional outcome, and 3) correlate with cognitive dysfunction, especially in the area of attentional control.
Another primary obstacle is accessibility of care. This is especially true in New Mexico, which is a largely rural state with only a few population centers. Many individuals with TBI return to the medically under-served communities where access to care is more difficult. With our mobile MRI, The MRN unit can uniquely address the needs of this under-served population in New Mexico and adjoining states, establishing a model of diagnostic service for other rural locations in the United States.
MISSION STATEMENT
The MRN will utilize advanced multimodal imaging in combination with comprehensive neurocognitive and psychiatric assessments to further understand the changes in brain function that occur over time as a consequence of TBI. When necessary, we will bring our mobile imaging laboratories to rural populations where access to care is often a burden. Our ultimate goal is to use state-of-the-art neuroimaging technology to help those afflicted with TBI by 1) providing accurate and rapid diagnosis, 2) selecting appropriate therapy for patients, and 3) individualize therapy to optimize functional outcome.
Please see our list of publications for additional information regarding this MRS work and other findings from our TBI team. |
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Functional Imaging for Research and Schizophrenia Treatment A Program for Assessment, Treatment and Imaging Studies Schizophrenia is an enigmatic illness that affects 1% of the world’s population. Understanding this illness requires a well-controlled research program with a large number of patients and controls. The Mind Research Network (MRN) has addressed this severe mental illness by forming the Mind Clinical Imaging Consortium (MCIC). Under this program we have studied 178 patients and 170 healthy controls thus far. We have established a large data bank containing anatomical and functional MRI, MEG and immortalized cell lines for genetic data. We have developed a cross-site calibration of MRI and MEG and methods for unifying the analysis of MEG data across three different platforms that are installed in three MRN partner sites. The FIRST Program is an extension of the MCIC with a focus on early diagnosis of schizophrenia. Early detection will be important in understanding the development of this illness and in providing more effective care of these patients. The Mind Research Network, through its partnerships with Massachusetts General Hospital, the University of Minnesota and the University of New Mexico, has launched the Functional Imaging for Research and Schizophrenia Treatment (FIRST) Program. Through this collaboration we hope to gain a better understanding of serious mental illnesses. We anticipate that the knowledge gained from these studies will improve the treatment and prognosis of schizophrenia and other psychoses.
Schizophrenia, a potentially devastating mental illness, affects one percent of the population. The disease, which often develops a in person’s late teens or early twenties, can affect all aspects of life–from career and education, to relationships with others. The longer a psychotic illness is left untreated, the greater the disruption to the person’s life. Some research suggests that delays in treatment can lead to a slower and/or less complete recovery. However, through a combination of medication and psychosocial treatments, symptoms can often be controlled in about 80 percent of patients.
Clinicians and scientists at the Mind Research Network are actively working to improve the lives of people with schizophrenia. Our mission is to:
Improve the psychiatric and medical care of individuals with schizophrenia by providing:
• confidential consultation for accurate diagnosis and early detection
• expert evaluation, including structured interviews, medication and treatment evaluation, and neurocognitive testing
• ongoing assessment, including symptom monitoring and resource utilization
Educate patients, family members, the public, and fellow health professionals about treatments through:
• educational support groups for family members to improve skills for interacting with loved ones diagnosed with schizophrenia and related illnesses
• social and support groups for patients (education,smoking cessation, weight management)
• lectures for mental health care professionals and academics on schizophrenia and its treatment
Research the causes of schizophrenia and early diagnosis and prognosis through our:
• brain imaging program–sophisticated imaging techniques used to pinpoint brain regions that may be overactive or underactive in patients with schizophrenia
• genetics program–investigating possible links between genes and schizophrenia
What is the purpose of this research?
FIRST is a clinical research program designed to provide assistance to individuals who are experiencing early symptoms of psychosis or schizophrenia. The research specializes in the early diagnosis and treatment of individuals struggling with changes in their thoughts, behavior, and emotions that may be indicative of developing a serious mental illness.
What are some of the study procedures?
Participants in all our studies will be asked to complete a thorough assessment process, which will include a set of interviews, cognitive testing, genetic testing, as well as a brief medical and neurological exam. Neuroimaging participants will undergo non-invasive procedures involving MRI, MRS, and DTI technology.
Who is eligible to participate?
• People between the ages of 15 and 40 years who have experienced psychotic symptoms, which were not drug-induced, or who have been diagnosed with a psychotic illness, such as schizophrenia or schizoaffective disorder for less than two years
• We are also enrolling emotionally and physically healthy participants to serve as controls in our research
Additional Information
• Participation in all studies is strictly voluntary and can be discontinued at any time
• Participants generally incur no cost for study procedures and will be reimbursed for their time
• Participants who require immediate psychiatric attention will receive priority scheduling
Many of the services provided in the FIRST Program are made possible solely or partially through charitable contributions. We welcome and appreciate gifts of any size to help us continue to pursue cutting-edge research and offer patients and families the most advanced and effective care.
FIRST Investigators
Mind Research Network
• Jeremy Bockholt
• Vince Calhoun, PhD
• Vince Clark, PhD
• Chuck Gasparovic, PhD
• Kent Kiehl, PhD
• Jody Roberts, MS
Massachusetts General Hospital
• Elfar Alalsteinsson, PhD
• Corinne Cather, PhD
• Oliver Freudenreich, MD
• Don Goff, MD
• Daphne Holt M.D. PhD
• Bruce Jenkins, MD
University of Minnesota
• Dan Hanson, MD, PhD
• Sanjiv Kumra, MD
• Kelvin Lim, MD
• Chuck Schulz, MD
• Tonya White, MD
University of New Mexico
• Tara Biehl, MS
• Juan Bustillo, MD
• John Lauriello, MD
• Nora Perrone-Bizzozero, PhD For medical questions or information about becoming a research participant, please contact: Massachusetts General Hospital
617-912-7891
The University of Minnesota
612-627-4890
The University of New Mexico
505-272-9544 For more information about the FIRST Program, please contact:
The Mind Research Network
Jody Roberts, Program Manager
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
505-272-3171
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