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Filter by:Many critically ill newborns in the neonatal intensive care (NICU) or critical care unit (NCCU) environment develop feeding and movement problems. The purpose of this study was to determine the extent to which neurophysiologically based occupational therapy intervention (NBOTI) for NCCU infants would affect the intervention group's oral feeding and other covariates, such as heart rate variability (HRV) during feeding. The biopsychosocial model provided the study's conceptual framework. The key research question explored whether NBOTI in the NCCU promoted healthy infant development through feeding, movement organization, and parent self-efficacy. This exploratory study with 10 NCCU infants and 10 historical matched controls utilized a mixed method design of qualitatively coded video analysis and inferential statistics such as the t test, the binomial test, hierarchal linear modeling (HLM), and multivariate analysis. Significant differences were obtained between the intervention and comparison groups in the number of days from all tube to all oral feeding before discharge and speed at which the infants gained weight. Longitudinal analyses of the intervention group data were employed to reveal significant trends and pre/post differences in the HRV data along with how quickly the infants ate, parent perceptions of self efficacy and decreased stress in the NCCU. Finally, qualitative findings obtained from videotape analysis provide further evidence that NBOTI was effective in facilitating feeding and promoting development. The recommendations are to replicate this study to validate and expand the findings of the current study. The model for infant care suggested by the findings could contribute to positive social change by fostering positive physical and emotional child development and healthy child-parent and family-caregiver relationships.
This study will attempt to increase understanding of why bipolar disorder patients do or do not take their medications by conducting in-depth interviews with them.
This study is a randomized controlled trial comparing two treatments for patients with comorbid substance use disorder (SUD) and post-traumatic stress disorder (PTSD) conducted within two different routine clinical settings for the treatment of SUD, namely (a) a day-care and inpatient setting and (b) an outpatient setting. Participants will be randomly assigned to either (1) a combination of cognitive-behavioral treatment (CBT) for SUD and trauma-focused structured writing therapy, or (2) CBT for SUD alone. Randomization will take place separately for each setting. It is expected that the combined treatment is significantly more effective in reducing symptoms of SUD as well as PTSD than CBT for SUD alone. Outcome measures will be assessed at pre-treatment, post-treatment as well as 3 months, 6 months and 12 months follow-up.
Depression is a common illness with an approximate lifetime prevalence of 17 %, conferring a large burden of disease in the community, often due to inadequate treatment. Thus there is interest in the therapeutic potential of non invasive, novel forms of brain stimulation, such as transcranial direct current stimulation (tDCS). Two small studies have been published in the last two years indicating that 20 minutes of either 1 or 2mA tDCS over 5 or 10 sessions is safe, painless and well tolerated. The investigators' own pilot data (N=30) also suggests the technique has antidepressant effects and is safe (5-10 sessions of tDCS at 1 mA). This study will extend previous findings, testing a more definitive tDCS approach (also left prefrontal anodal stimulation) with a longer treatment course (15 sessions), at 2 mA (which has been found to be safe and more effective than 1 mA in cognitive studies), and in a larger sample (N=68), using a placebo-controlled design. It is hypothesised that active tDCS (15 sessions) will have greater efficacy than sham treatment (15 sessions) in reducing the severity of depressive symptoms in patients in an episode of major depression. A second hypothesis is that 15 sessions of tDCS will not cause any significant adverse effects or cause decline in neuropsychological functioning in comparison to a sham control.
The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance cognitive abilities (specifically measures of attention, executive function, working memory, and visuospatial ability) in persons with bipolar disorder. Secondarily, the investigators hypothesize there will be secondary improvements in residual mood/anxiety symptoms, and metabolic indices, if impaired (fasting blood glucose and lipids). The investigators aim to test these hypotheses by conducting a randomized, placebo controlled, add on treatment trial of Sensoril® (added to existing mood stabilizer treatment) recruiting 60 subjects with DSM IV-TR bipolar disorder for a period of 8 weeks. Measures of cognition, psychopathology and laboratory indices will be utilized for evaluating primary and secondary outcomes, along with safety assessments.
This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
This study will test whether transcranial direct current stimulation (TDCS) can be used safely in children with schizophrenia and if it can improve memory and attention span or auditory hallucinations in these children, at least temporarily. TDCS has temporarily improved memory and attention span in healthy adults and a similar method called TMS has relieved auditory hallucinations in adults with schizophrenia. For the TDCS procedure, the child sits in a chair and two soft sponge electrodes are placed on the child s forehead and held in place with a soft wrapping. One sponge electrode is placed on an arm. The electrodes are attached to a stimulator with a wire. Children with schizophrenia who meet the following criteria may be eligible for this study: - Are 10 yrs or older age. - Are participating in NIH protocol 03-M-0035. - Are on a stable medication regimen for at least 6 months. - Have problems with memory and attention span or have auditory hallucinations. Participants are randomly assigned to receive either real or sham TDCS on an inpatient or outpatient basis in 20-minute sessions daily, except weekends, for 10 days. For real TDCS, patients receive stimulation to the front of the brain. For sham stimulation, the children have electrodes placed on the forehead, but no actual stimulation is delivered. In addition to TDCS, patients have the following procedures: - Checks of blood pressure, pulse and breathing rate before, during and right after each stimulation and again 8 hours later. - Electrocardiogram (EKG) and electroencephalogram (EEG) before starting stimulation and after completing the 10 days of TDCS. - Interviews and examinations to check for side effects of TDCS. - Pen-and-paper or computer tests of learning, attention and memory. - At the end of the 10 sessions, children who were in the sham TDCS group are offered the same number of sessions of active TDCS. - Follow-up telephone call 1 month after the end of stimulation to see how the child is doing. - 1- to 2-day outpatient visit 6 months after the stimulation. This visit includes interviews with the parent and the child, rating of the child s psychiatric symptoms, and pen-and-paper or computer tests of thinking, attention and memory.
Autism spectrum disorder (ASD) has been given a high priority for genetic and neurobiological study. There is no such information in Asian population and no study has conducted using Diffusion Spectrum Imaging (DSI) to investigate the connectivity throughout the world. Moreover, no follow-up study has been done to examine the developmental changes of structural and functional connectivity. We anticipate to establishing a cohort of 50 ASD and their siblings with complete clinical, neuropsychological, brain imaging, and genetic data for longitudinal study on ASD. Our findings will contribute to our understanding of the structural and functional dysconnectivity for ASD and whether dysconnectivity can be an endophenotype for ASD and used as a biomarker for early diagnosis of ASD.
This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).
RATIONALE: Providing information that is tailored to answer patients' questions about clinical trials may help patients with cancer decide to enroll in a clinical trial. It is not known whether providing personalized information is more effective than basic information in helping patients make decisions about clinical trials. PURPOSE: This randomized phase III trial is studying personalized information to see how well it works compared with basic information in helping patients make decisions about participating in a clinical trial.