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1.
J Clin Transl Sci ; 8(1): e63, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38655451

RESUMO

Background: Impaired motor and cognitive function can make travel cumbersome for People with Parkinson's disease (PwPD). Over 50% of PwPD cared for at the University of Arkansas for Medical Sciences (UAMS) Movement Disorders Clinic reside over 30 miles from Little Rock. Improving access to clinical care for PwPD is needed. Objective: To explore the feasibility of remote clinic-to-clinic telehealth research visits for evaluation of multi-modal function in PwPD. Methods: PwPD residing within 30 miles of a UAMS Regional health center were enrolled and clinic-to-clinic telehealth visits were performed. Motor and non-motor disease assessments were administered and quantified. Results were compared to participants who performed at-home telehealth visits using the same protocols during the height of the COVID pandemic. Results: Compared to the at-home telehealth visit group (n = 50), the participants from regional centers (n = 13) had similar age and disease duration, but greater disease severity with higher total Unified Parkinson's disease rating scale scores (Z = -2.218, p = 0.027) and lower Montreal Cognitive Assessment scores (Z = -3.350, p < 0.001). Regional center participants had lower incomes (Pearson's chi = 21.3, p < 0.001), higher costs to attend visits (Pearson's chi = 16.1, p = 0.003), and lived in more socioeconomically disadvantaged neighborhoods (Z = -3.120, p = 0.002). Prior research participation was lower in the regional center group (Pearson's chi = 4.5, p = 0.034) but both groups indicated interest in future research participation. Conclusions: Regional center research visits in PwPD in medically underserved areas are feasible and could help improve access to care and research participation in these traditionally underrepresented populations.

2.
Sci Rep ; 13(1): 22784, 2023 12 20.
Artigo em Inglês | MEDLINE | ID: mdl-38123606

RESUMO

Upper-limb bradykinesia occurs early in Parkinson's disease (PD) and bradykinesia is required for diagnosis. Our goal was to develop, implement and validate a game "walking" a frog through a maze using bimanual, alternating finger-tapping movements to provide a salient, objective, and remotely monitorable method of tracking disease progression and response to therapy in PD. Twenty-five people with PD and 16 people without PD participated. Responses on 5 different mazes were quantified and compared to spatiotemporal gait parameters and standard disease metrics in these participants. Intertap interval (ITI) on maze 2 & 3, which included turns, was strongly inversely related to stride-length and stride-velocity and directly related to motor UPDRS scores. Levodopa decreased ITI, except in maze 4. PD participants with freezing of gait had longer ITI on all mazes. The responses quantified on maze 2 & 3 were related to disease severity and gait stride-length, were levodopa responsive, and were worse in people with freezing of gait, suggesting that these mazes could be used to quantify motor dysfunction in PD. Programming our frog-in-maze game onto a remotely distributable platform could provide a tool to monitor disease progression and therapeutic response in people with PD, including during clinical trials.


Assuntos
Transtornos Neurológicos da Marcha , Doença de Parkinson , Humanos , Doença de Parkinson/tratamento farmacológico , Levodopa/farmacologia , Levodopa/uso terapêutico , Hipocinesia , Movimento , Extremidade Superior , Marcha/fisiologia , Progressão da Doença
3.
Sci Rep ; 13(1): 20615, 2023 11 23.
Artigo em Inglês | MEDLINE | ID: mdl-37996478

RESUMO

Machine learning approaches have been used for the automatic detection of Parkinson's disease with voice recordings being the most used data type due to the simple and non-invasive nature of acquiring such data. Although voice recordings captured via telephone or mobile devices allow much easier and wider access for data collection, current conflicting performance results limit their clinical applicability. This study has two novel contributions. First, we show the reliability of personal telephone-collected voice recordings of the sustained vowel /a/ in natural settings by collecting samples from 50 people with specialist-diagnosed Parkinson's disease and 50 healthy controls and applying machine learning classification with voice features related to phonation. Second, we utilize a novel application of a pre-trained convolutional neural network (Inception V3) with transfer learning to analyze the spectrograms of the sustained vowel from these samples. This approach considers speech intensity estimates across time and frequency scales rather than collapsing measurements across time. We show the superiority of our deep learning model for the task of classifying people with Parkinson's disease as distinct from healthy controls.


Assuntos
Doença de Parkinson , Voz , Humanos , Doença de Parkinson/diagnóstico , Reprodutibilidade dos Testes , Fonação , Aprendizado de Máquina
4.
Artigo em Inglês | MEDLINE | ID: mdl-36767297

RESUMO

Almost 40% of US adults provide informal caregiving, yet research gaps remain around what burdens affect informal caregivers. This study uses a novel social media site, Reddit, to mine and better understand what online communities focus on as their caregiving burdens. These forums were accessed using an application programming interface, a machine learning classifier was developed to remove low information posts, and topic modeling was applied to the corpus. An expert panel summarized the forums' themes into ten categories. The largest theme extracted from Reddit's forums discussed the personal emotional toll of being a caregiver. This was followed by logistic issues while caregiving and caring for parents who have cancer. Smaller themes included approaches to end-of-life care, physical equipment needs when caregiving, and the use of wearables or technology to help monitor care recipients. The platform often discusses caregiving for parents which may reflect the age of Reddit's users. This study confirms that Reddit forums are used for caregivers to discuss the burdens associated with their role and the types of stress that can result from informal caregiving.


Assuntos
Sobrecarga do Cuidador , Mídias Sociais , Adulto , Humanos , Cuidadores/psicologia
5.
J Clin Transl Sci ; 7(1): e3, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36755541

RESUMO

Background/Objective: Informed consent forms (ICFs) and practices vary widely across institutions. This project expands on previous work at the University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy to develop a plain language ICF template. Our interdisciplinary team of researchers, comprised of biomedical informaticists, health literacy experts, and stakeholders in the Institutional Review Board (IRB) process, has developed the ICF Navigator, a novel tool to facilitate the creation of plain language ICFs that comply with all relevant regulatory requirements. Methods: Our team first developed requirements for the ICF Navigator tool. The tool was then implemented by a technical team of informaticists and software developers, in consultation with an informed consent legal expert. We developed and formalized a detailed knowledge map modeling regulatory requirements for ICFs, which drives workflows within the tool. Results: The ICF Navigator is a web-based tool that guides researchers through creating an ICF as they answer questions about their project. The navigator uses those responses to produce a clear and compliant ICF, displaying a real-time preview of the final form as content is added. Versioning and edits can be tracked to facilitate collaborative revisions by the research team and communication with the IRB. The navigator helps guide the creation of study-specific language, ensures compliance with regulatory requirements, and ensures that the resulting ICF is easy to read and understand. Conclusion: The ICF Navigator is an innovative, customizable, open-source software tool that helps researchers produce custom readable and compliant ICFs for research studies involving human subjects.

6.
Sci Rep ; 12(1): 4180, 2022 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-35264705

RESUMO

Movement amplitude setting is affected early in Parkinson's disease (PD), clinically manifesting as bradykinesia. Our objective was to determine if amplitude setting of upper limb bimanual movements and bipedal gait are similarly modulated in PD. 27 PD and 24 control participants were enrolled. Participants performed a bimanual anti-phase finger tapping task wearing gloves with joint angular sensors, and an instrumented gait assessment. Participants performed normal and fast paced assessments to vary motor load. PD participants were evaluated OFF (PD-OFF) and ON (PD-ON) levodopa. PD-OFF participants had smaller tap amplitude, and greater tap amplitude variability than controls in the more affected hands (all p < 0.05). Tap amplitude and stride length (p = 0.030) were correlated in PD-OFF. Tap amplitude was also correlated with motor UPDRS (p < 0.005) and bradykinesia motor (p < 0.05) and ADL (p < 0.005) UPDRS subscores. The relative amount of improvement in tap amplitude and stride length with levodopa was correlated. In PD, upper limb and gait amplitude setting are similarly scaled with motor demand and dopamine supplementation. This suggests these automated motor functions are subserved by common functional networks.


Assuntos
Doença de Parkinson , Dopamina , Marcha/fisiologia , Humanos , Hipocinesia , Levodopa/farmacologia , Levodopa/uso terapêutico
7.
Epilepsia ; 63(3): 525-536, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34985784

RESUMO

Epilepsy, a neurological disorder characterized by recurrent seizures, is known to be associated with impaired sleep and memory. Although the specific mechanisms underlying these impairments are uncertain, the known role of sleep in memory consolidation suggests a potential relationship may exist between seizure activity, disrupted sleep, and memory impairment. A possible mediator in this relationship is the sleep spindle, the characteristic electroencephalographic (EEG) feature of non-rapid-eye-movement (NREM) sleep in humans and other mammals. Growing evidence supports the idea that sleep spindles, having thalamic origin, may mediate the process of long-term memory storage and plasticity by generating neuronal conditions that favor these processes. To study this potential relationship, a single model in which memory, sleep, and epilepsy can be simultaneously observed is of necessity. Rodent models of epilepsy appear to fulfill this requirement. Not only do rodents express both sleep spindles and seizure-induced sleep disruptions, but they also allow researchers to invasively study neurobiological processes both pre- and post- epileptic onset via the artificial induction of epilepsy (a practice that cannot be carried out in human subjects). However, the degree to which sleep architecture differs between rodents and humans makes direct comparisons between the two challenging. This review addresses these challenges and concludes that rodent sleep studies are useful in observing the functional roles of sleep and how they are affected by epilepsy.


Assuntos
Epilepsia , Consolidação da Memória , Animais , Eletroencefalografia , Humanos , Roedores , Convulsões , Sono/fisiologia
8.
J Clin Transl Sci ; 6(1): e133, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36590358

RESUMO

Introduction: Gait, balance, and cognitive impairment make travel cumbersome for People with Parkinson's disease (PwPD). About 75% of PwPD cared for at the University of Arkansas for Medical Sciences' Movement Disorders Clinic reside in medically underserved areas (MUAs). Validated remote evaluations could help improve their access to care. Our goal was to explore the feasibility of telemedicine research visits for the evaluation of multi-modal function in PwPD in a rural state. Methods: In-home telemedicine research visits were performed in PwPD. Motor and non-motor disease features were evaluated and quantified by trained personnel, digital survey instruments for self-assessments, digital voice recordings, and scanned and digitized Archimedes spiral drawings. Participant's MUA residence was determined after evaluations were completed. Results: Twenty of the fifty PwPD enrolled resided in MUAs. The groups were well matched for disease duration, modified motor UPDRS, and Montreal Cognitive assessment scores but MUA participants were younger. Ninety-two percent were satisfied with their visit, and 61% were more likely to participate in future telemedicine research. MUA participants traveled longer distances, with higher travel costs, lower income, and education level. While 50% of MUA participants reported self-reliance for in-person visits, 85% reported self-reliance for the telemedicine visit. We rated audio-video quality highly in approximately 60% of visits in both groups. There was good correlation with prior in-person research assessments in a subset of participants. Conclusions: In-home research visits for PwPD in MUAs are feasible and could help improve access to care and research participation in these traditionally underrepresented populations.

9.
Front Artif Intell ; 4: 649970, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-35224477

RESUMO

Neuroimaging is among the most active research domains for the creation and management of open-access data repositories. Notably lacking from most data repositories are integrated capabilities for semantic representation. The Arkansas Imaging Enterprise System (ARIES) is a research data management system which features integrated capabilities to support semantic representations of multi-modal data from disparate sources (imaging, behavioral, or cognitive assessments), across common image-processing stages (preprocessing steps, segmentation schemes, analytic pipelines), as well as derived results (publishable findings). These unique capabilities ensure greater reproducibility of scientific findings across large-scale research projects. The current investigation was conducted with three collaborating teams who are using ARIES in a project focusing on neurodegeneration. Datasets included magnetic resonance imaging (MRI) data as well as non-imaging data obtained from a variety of assessments designed to measure neurocognitive functions (performance scores on neuropsychological tests). We integrate and manage these data with semantic representations based on axiomatically rich biomedical ontologies. These instantiate a knowledge graph that combines the data from the study cohorts into a shared semantic representation that explicitly accounts for relations among the entities that the data are about. This knowledge graph is stored in a triple-store database that supports reasoning over and querying these integrated data. Semantic integration of the non-imaging data using background information encoded in biomedical domain ontologies has served as a key feature-engineering step, allowing us to combine disparate data and apply analyses to explore associations, for instance, between hippocampal volumes and measures of cognitive functions derived from various assessment instruments.

10.
J Clin Transl Sci ; 4(5): 384-388, 2020 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-33244426

RESUMO

The University of Arkansas for Medical Sciences (UAMS), like many rural states, faces clinical and research obstacles to which digital innovation is seen as a promising solution. To implement digital technology, a mobile health interest group was established to lay the foundation for an enterprise-wide digital health innovation platform. To create a foundation, an interprofessional team was established, and a series of formal networking events was conducted. Three online digital health training models were developed, and a full-day regional conference was held featuring nationally recognized speakers and panel discussions with clinicians, researchers, and patient advocates involved in digital health programs at UAMS. Finally, an institution-wide survey exploring the interest in and knowledge of digital health technologies was distributed. The networking events averaged 35-45 attendees. About 100 individuals attended the regional conference with positive feedback from participants. To evaluate mHealth knowledge at the institution, a survey was completed by 257 UAMS clinicians, researchers, and staff. It revealed that there are opportunities to increase training, communication, and collaboration for digital health implementation. The inclusion of the mobile health working group in the newly formed Institute for Digital Health and Innovation provides a nexus for healthcare providers and researches to facilitate translational research.

11.
Otolaryngol Head Neck Surg ; 163(3): 546-553, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32450778

RESUMO

OBJECTIVE: To identify the dominant clinical factors associated with increased 1-year charges in treating head and neck cancer. STUDY DESIGN: Retrospective review. SETTING: Single academic institution. SUBJECTS AND METHODS: We retrospectively reviewed 1-year charges for 196 consecutive patients with head and neck cancer (HNC) who were treated exclusively at our institution. We analyzed charges by department as well as factors associated with increased charges per multivariable regression. RESULTS: The mean age was 59.6 years (SD, 14.9). Most of the population was male (64%), white (70%), and commercially insured (46%). The most common primary sites were the oropharynx (25%; 76%, HPV positive), skin (19%), and thyroid (17%). Eighty-three percent of total charges were due to standard-of-care treatment for HNC: surgery ($16 million), radiation therapy ($22 million), or chemotherapy ($11 million). The median total charge per patient was $212,484 (interquartile range, $78,630-$475,823). Multivariable regression demonstrated that the following were associated with increased charges: nasopharynx subsite ($250,929 [95% CI, $93,290-$408,569]; effect size in US dollars, P = .002), advanced stage (American Joint Committee on Cancer, seventh edition; $80,331 [$22,726-$137,936], P = .007), therapeutic surgery ($281,893 [$117,371-$446,415], P = .001), chemotherapy ($183,331 [$125,497-$241,165], P < .001), radiation ($203,397 [$143,454-$263,341], P < .001), surgical complication requiring return to the operating room ($147,247 [$37,240-$257,254], P = .009), emergency department visits ($89,050 [$23,811-$154,289], P = .008), and admissions ($140,894 [$82,895-$198,893], P < .001; constant, -$233,927 [-$410,790 to -$57,064]). The top quartile accrued 55% of the total charges. CONCLUSION: Radiation, followed by surgery and chemotherapy, were the most expensive components of HNC care. In this analysis, we identified the dominant clinical factors associated with increased charges.


Assuntos
Honorários e Preços , Neoplasias de Cabeça e Pescoço/economia , Neoplasias de Cabeça e Pescoço/terapia , Custos de Cuidados de Saúde , Idoso , Terapia Combinada/economia , Feminino , Neoplasias de Cabeça e Pescoço/patologia , Hospitalização/economia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados Unidos
12.
Bioinformatics ; 35(1): 119-121, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-29931085

RESUMO

Summary: Standardized interfaces for efficiently accessing high-throughput sequencing data are a fundamental requirement for large-scale genomic data sharing. We have developed htsget, a protocol for secure, efficient and reliable access to sequencing read and variation data. We demonstrate four independent client and server implementations, and the results of a comprehensive interoperability demonstration. Availability and implementation: http://samtools.github.io/hts-specs/htsget.html. Supplementary information: Supplementary data are available at Bioinformatics online.


Assuntos
Biologia Computacional , Genômica , Sequenciamento de Nucleotídeos em Larga Escala , Software , Genoma
13.
Ann Thorac Surg ; 99(6): 2141-7; discussion 2147-9, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25886808

RESUMO

BACKGROUND: In 2007 we began a hybrid program for hypoplastic left heart syndrome (HLHS) variants to potentially improve outcome in high-risk patients. During implementation we offered both hybrid and Norwood approaches to all risk categories. The purpose of this study was to perform a comparative analysis of intermediate survival. METHODS: Newborns were evaluated jointly for high-risk characteristics, including birth weight less than 2.5 kg, prematurity (especially < 35 weeks), central nervous system abnormalities, multiorgan failure, intact or severely restrictive atrial septum, severe ventricular dysfunction, and severe atrioventricular valve regurgitation. We prefer Norwood for standard risk and hybrid for high risk, but all groups crossed over into all treatment pathways resulting in the following 5 treatment groups: standard risk Norwood; high-risk Norwood; standard risk hybrid ductal stent (HDS); high-risk hybrid DS; and high-risk hybrid prostaglandin E1 (HPGE). We reviewed all consecutive patients from 2007 to 2012, obtained follow-up, and analyzed the results. RESULTS: Sixty-eight newborns presented (median 2.96 kg, 8 days); 29 (43%) were high and 39 (57%) were standard risk. There were 14 stage I hospital deaths strongly associated with risk: 3 of 39 standard (7.7%) and 11 of 29 high (38%, p = 0.002). Stage I discharge mortality was highest for high-risk Norwood and high-risk HPGE groups (p < 0.001). Actuarial survival up to 5 years demonstrated superior survival for Norwood versus hybrid (78.1% vs 56.4%, p = 0.0182). With risk stratification there was suboptimal survival for all 3 high-risk groups (p = 0.003); HDS fared better than HPGE but had higher birth weight (p < 0.001). CONCLUSIONS: While a risk-stratified approach for HLHS variant patients with selective use of hybrid palliation resulted in acceptable stage I mortality, the longer term mortality for high-risk patients remains higher than for standard risk regardless of treatment modality. Intrinsic patient risk factors (rather than treatment modality) likely determine long-term outcome in experienced centers. Our current high-risk approach has evolved to HPGE application with Norwood conversion whenever deemed medically possible.


Assuntos
Prótese Vascular , Canal Arterial/cirurgia , Síndrome do Coração Esquerdo Hipoplásico/cirurgia , Procedimentos de Norwood , Artéria Pulmonar/cirurgia , California/epidemiologia , Feminino , Seguimentos , Humanos , Síndrome do Coração Esquerdo Hipoplásico/mortalidade , Lactente , Recém-Nascido , Masculino , Cuidados Paliativos/métodos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
14.
Nonlinear Dynamics Psychol Life Sci ; 18(3): 277-96, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24894266

RESUMO

Severe and persistent self-injurious behavior (SIB) is notoriously difficult to understand and to treat. The current study used self-organization theory to investigate the possible relationship between SIB and changing levels of behavioral flexibility. Data consisted of categorical time-series of sequential behaviors from individuals with developmental disabilities and severe SIB. Orbital Decomposition was used to analyze each series for measures of structure and entropy. Overall, results showed evidence for self-organization in behavior patterns. Second, series including SIB were on average more flexible than those without SIB; while, higher numbers of SIB events (perseveration) were associated with higher behavioral rigidity and structural disintegration. Finally, there was evidence that behavioral flexibility almost always shifts reliably after a discrete bout of SIB, either increasing or decreasing in complexity. Altogether, these results may provide a deeper and more theoretically grounded understanding of the function of SIB beyond the traditional behavioral paradigm involving simple stimulus-response or response-consequence relations. Instead, some behaviors, such as SIB, may serve a resilience-making function as more global regulators of behavioral flexibility and coherence.


Assuntos
Deficiências do Desenvolvimento/psicologia , Resiliência Psicológica , Comportamento Autodestrutivo/psicologia , Adulto , Deficiências do Desenvolvimento/complicações , Feminino , Fractais , Humanos , Masculino , Transtornos Mentais , Dinâmica não Linear , Comportamento Autodestrutivo/complicações
15.
Psychiatr Rehabil J ; 36(4): 231-5, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24320831

RESUMO

OBJECTIVE: To explore mental health consumer and provider responses to a computerized version of the Illness Management and Recovery (IMR) program. METHOD: Semistructured interviews were conducted to gather data from 6 providers and 12 consumers who participated in a computerized prototype of the IMR program. An inductive-consensus-based approach was used to analyze the interview responses. RESULTS: Qualitative analysis revealed consumers perceived various personal benefits and ease of use afforded by the new technology platform. Consumers also highly valued provider assistance and offered several suggestions to improve the program. The largest perceived barriers to future implementation were lack of computer skills and access to computers. Similarly, IMR providers commented on its ease and convenience, and the reduction of time intensive material preparation. Providers also expressed that the use of technology creates more options for the consumer to access treatment. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: The technology was acceptable, easy to use, and well-liked by consumers and providers. Clinician assistance with technology was viewed as helpful to get clients started with the program, as lack of computer skills and access to computers was a concern. Access to materials between sessions appears to be desired; however, given perceived barriers of computer skills and computer access, additional supports may be needed for consumers to achieve full benefits of a computerized version of IMR.


Assuntos
Atitude do Pessoal de Saúde , Atitude Frente a Saúde , Instrução por Computador , Transtornos Mentais/reabilitação , Educação de Pacientes como Assunto/métodos , Atitude Frente aos Computadores , Feminino , Acessibilidade aos Serviços de Saúde , Humanos , Internet , Masculino , Transtornos Mentais/psicologia , Pessoa de Meia-Idade , Avaliação de Programas e Projetos de Saúde , Pesquisa Qualitativa , Fatores de Tempo
16.
Bipolar Disord ; 15(3): 314-25, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23531082

RESUMO

OBJECTIVES: Our laboratory recently identified the P85 gating ratio as a candidate biomarker for bipolar disorder. In order to evaluate the phenomenological significance of P85 gating, the current study examined reports of perceptual anomalies and their relationship to the P50 and P85 physiological measures of sensory gating. METHODS: Reports of perceptual anomalies on the Structured Clinical Interview to Assess Perceptual Anomalies were compared in patients meeting DSM-IV criteria for paranoid schizophrenia (n = 66), schizoaffective disorder (n = 45), or bipolar I disorder (n = 42), and controls (n = 56), as well as their relationship with P85 and P50 gating. RESULTS: The bipolar disorder group reported significantly more auditory, visual, and total anomalies than both the schizophrenia and control groups. The schizophrenia group also had more anomalies than the control group. Comparison of psychiatric subgroups revealed that the bipolar depressed, bipolar disorder with psychosis, and schizoaffective bipolar type groups reported the most anomalies compared to the other patient groups (bipolar disorder without psychosis, schizoaffective, bipolar manic). The total perceptual anomalies score and the P85 ratio significantly differentiated the bipolar disorder, schizoaffective, and paranoid schizophrenia groups from each other. CONCLUSIONS: These findings provide evidence of the phenomenological significance of P85. The results also yield further support not only for the P85 ratio, but also for increased reports of perceptual anomalies as possible markers for bipolar disorder.


Assuntos
Transtorno Bipolar/complicações , Transtorno Bipolar/patologia , Encéfalo/fisiopatologia , Potenciais Evocados/fisiologia , Transtornos da Percepção/etiologia , Filtro Sensorial/fisiologia , Adulto , Análise de Variância , Manual Diagnóstico e Estatístico de Transtornos Mentais , Eletroencefalografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estimulação Física , Valor Preditivo dos Testes , Transtornos Psicóticos/complicações , Esquizofrenia/complicações , Estatística como Assunto
17.
Brain Stimul ; 5(4): 560-8, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22019083

RESUMO

BACKGROUND: Alpha EEG guided Transcranial Magnetic Stimulation (αTMS) of the dorsolateral prefrontal cortex (DLPFC) has shown promising efficacy for treating the negative symptoms of schizophrenia. OBJECTIVE/ HYPOTHESIS: The purpose of the current investigation was to test (1) the therapeutic effect in other domains of symptoms of schizophrenia and (2) the specificity of stimulus location. The hypothesis to be tested was that global alpha EEG normalization after αTMS would help improve the clinical symptoms of schizophrenia, regardless of the site of stimulation. METHOD: Seventy-eight patients with schizophrenia were enrolled in a randomized, double-blind, sham-controlled study with four study groups: frontal αTMS, parietal αTMS, frontal sham, and parietal sham. Patients received daily treatment for 10 days and clinical evaluations at day 5 and 10. The stimulus rate and intensity were determined by individual's characteristic alpha frequency and motor threshold (80%). RESULTS: Positive and general psychotic symptoms improved significantly after αTMS (P < 0.02). Frontal and parietal αTMS had similar effects (P = 0.48). (3) αTMS with concomitant typical neuroleptics treatment had greater efficacy than atypical neuroleptics (P < 0.04). Degree of EEG normalization as measured by increase in Q factor was highly associated with the improvement in all three domains of symptoms of schizophrenia (P < 0.04). CONCLUSIONS: Alpha EEG normalization after treatment with αTMS may directly subserve the processes underlying clinical improvements in schizophrenia. Nonetheless, given the confound of possible unblinding of participants because of an inactive sham control, the current results should be considered preliminary until replicated further.


Assuntos
Ritmo alfa/fisiologia , Lobo Frontal/fisiopatologia , Lobo Parietal/fisiopatologia , Esquizofrenia/terapia , Estimulação Magnética Transcraniana/métodos , Adulto , Método Duplo-Cego , Eletroencefalografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Esquizofrenia/fisiopatologia , Resultado do Tratamento
18.
Schizophr Bull ; 36(3): 504-9, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-18723840

RESUMO

On September 18, 2007, a collaborative session between the International Society for CNS Clinical Trials and Methodology and the International Society for CNS Drug Development was held in Brussels, Belgium. Both groups, with membership from industry, academia, and governmental and nongovernmental agencies, have been formed to address scientific, clinical, regulatory, and methodological challenges in the development of central nervous system therapeutic agents. The focus of this joint session was the apparent diminution of drug-placebo differences in recent multicenter trials of antipsychotic medications for schizophrenia. To characterize the nature of the problem, some presenters reported data from several recent trials that indicated higher rates of placebo response and lower rates of drug response (even to previously established, comparator drugs), when compared with earlier trials. As a means to identify the possible causes of the problem, discussions covered a range of methodological factors such as participant characteristics, trial designs, site characteristics, clinical setting (inpatient vs outpatient), inclusion/exclusion criteria, and diagnostic specificity. Finally, possible solutions were discussed, such as improving precision of participant selection criteria, improving assessment instruments and/or assessment methodology to increase reliability of outcome measures, innovative methods to encourage greater subject adherence and investigator involvement, improved rater training and accountability metrics at clinical sites to increase quality assurance, and advanced methods of pharmacokinetic/pharmacodynamic modeling to optimize dosing prior to initiating large phase 3 trials. The session closed with a roundtable discussion and recommendations for data sharing to further explore potential causes and viable solutions to be applied in future trials.


Assuntos
Antipsicóticos/uso terapêutico , Esquizofrenia/tratamento farmacológico , Psicologia do Esquizofrênico , Antipsicóticos/efeitos adversos , Antipsicóticos/farmacocinética , Viés , Ensaios Clínicos Fase III como Assunto , Comportamento Cooperativo , Relação Dose-Resposta a Droga , Humanos , Comunicação Interdisciplinar , Cooperação Internacional , Estudos Multicêntricos como Assunto , Efeito Placebo , Escalas de Graduação Psiquiátrica/estatística & dados numéricos , Psicometria/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Reprodutibilidade dos Testes , Esquizofrenia/sangue , Esquizofrenia/diagnóstico , Sociedades Médicas , Sociedades Farmacêuticas , Resultado do Tratamento
19.
Int J Alzheimers Dis ; 20092009 Dec 22.
Artigo em Inglês | MEDLINE | ID: mdl-20798873

RESUMO

The International Society for CNS Clinical Trials and Methodology (ISCTM) held its 4th Annual Autumn Conference in Toronto, Ontario, October 6-7, 2008. The purpose of the present report is to provide an overview of one of the sessions at the conference which focused on the designs and methodologies to be applied in clinical trials of new treatments for Alzheimer's disease (AD) with purported "disease-modifying" effects. The session began with a discussion of how neuroimaging has been applied in multiple sclerosis clinical trials (another condition for which disease modification claims have been achieved). The next two lectures provided a pharmaceutical industry perspective on some of the specific challenges and possible solutions for designing trials to measure disease progression and/or modification. The final lecture provided an academic viewpoint and the closing discussion included additional academic and regulatory perspectives on trial designs, methodologies, and statistical issues relevant to the disease modification concept.

20.
J Thorac Cardiovasc Surg ; 136(6): 1569-75, 2008 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-19114208

RESUMO

OBJECTIVE: Airway stenoses have been a significant cause of morbidity and mortality after lung transplantation. We reviewed our 11-year experience with dilatation and silicone stent treatment of airway strictures after lung transplantation. We adopted this approach after managing the complications of nitinol/wire mesh stents, including stent fracture, granulation tissue overgrowth, and difficulty with removal. METHODS: Between January of 1996 and December of 2007, 240 patients underwent lung transplantation (132 single lung, 108 double lung; 121 male, 119 female; mean age 49.4 +/- 12.9 years). Twenty patients (8.3%) developed >50% stenosis in 22 airways over 35 to 135 days following surgery. Short and long-segment strictures were managed with rigid bronchoscopy, mechanical/laser debridement, balloon dilatation, and silicone stent placement. Mean follow-up was 4.9 +/- 3.5 years after stent removal. RESULTS: The mean time to diagnosis of airway stenosis was 81.5 +/- 26.9 days. Pulmonary aspergillosis and pseudomonal infection, age less than 45 years, and early rejection correlated with airway stenosis; however, ischemic time, side of transplant, and preoperative disease did not. Airway patency and symptom improvement were achieved in 18 of 20 patients. Sixteen patients were able to have their stents removed at a mean of 362.3 +/- 126.4 days with permanent resolution of airway stenosis. Overall survival was similar for patients with and without airway stenosis. CONCLUSION: Airway stenosis after lung transplantation can be successfully managed with bronchoscopic dilatation and temporary silicone stent placement. With time, most short and long airway stenoses resolve with atraumatic stenting of the affected areas. Removal of stents with permanent airway patency is achievable in most lung transplant recipients with airway stenosis.


Assuntos
Obstrução das Vias Respiratórias/cirurgia , Brônquios/patologia , Transplante de Pulmão/efeitos adversos , Adulto , Obstrução das Vias Respiratórias/etiologia , Materiais Biocompatíveis , Brônquios/cirurgia , Broncoscopia , Constrição Patológica/etiologia , Constrição Patológica/cirurgia , Desbridamento , Dilatação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Silicones , Stents
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