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NCT06570954
The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of adult psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 19 years and older participants diagnosed with PNES who are treated at UAB FND clinic will engage in twelve sessions of ReACT. Participants will be randomly assigned to one of three conditions: no wait, 3-month waiting period, 6-month waiting period. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale (PCS), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment and 7 days after the 12th treatment session. Participants randomized to the 3-month and 6-month waiting period will also complete these measures one additional time immediately before the beginning of their waiting period. Long term follow-up assessments will occur at 2 months, 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment. Participants randomized to the 3-month or 6-month waiting period conditions will log weekly PNES episodes until the start of therapy.
NCT05819268
The purpose of this study is to assess the feasibility of conducting a future fully powered multi-site efficacy Randomized Controlled Trial (RCT) comparing two treatments for pediatric functional seizures (FS). In this study, 11-18-year-olds diagnosed with FS will be randomized to 12 sessions of Retraining and Control Therapy (ReACT) or Competent Adulthood Transition with Cognitive Behavioral, Humanistic, and Interpersonal Training (CATCH-IT) at 3 sites: University of Alabama at Birmingham, Yale School of Medicine/Yale New Haven Children's Hospital and Baylor College of Medicine/Texas Children's Hospital. Feasibility of recruitment will be measured by the percentage of planned participant enrollment target obtained at each site and overall during the 18 months of planned enrollment. Acceptability will be assessed using the Acceptability Questionnaire. Participant retention will be measured by the percent of enrolled participants that complete the 2-month follow-up visit at each site and overall. For treatment fidelity assessment, 20% of each therapist's sessions will be randomly chosen and assessed for fidelity. Patient adherence will be measured in two ways: 1) the percent of ReACT or CATCH-IT sessions completed at each site and overall and 2) for ReACT, the percent of times participants report using the treatment plan during FS episodes (measured by FS diary) and for CATCH-IT, the number of times parents and children spend using CATCH-IT each week (measured by the CATCH-IT platform). These data will be used to support a future fully-powered multi-site RCT assessing the efficacy of ReACT for pediatric FS.
NCT07463222
Febrile seizures are the most common seizure type in early childhood and usually occur during febrile illnesses. Although most febrile seizures are benign, the biological stress response during seizures is not fully understood. In particular, changes in thyroid hormones and stress-related hormones released by the sympathetic nervous system may play a role in seizure characteristics and clinical outcomes. This prospective observational study aims to evaluate the neuroendocrine response in children presenting with febrile seizures by measuring serum thyroxine (T4), epinephrine, and norepinephrine levels. These measurements will be obtained during the acute phase after seizure cessation and compared with levels measured at recovery and with febrile children without seizures. The study will examine the relationship between neuroendocrine marker levels and seizure characteristics such as seizure duration and recurrence, as well as clinical outcomes including length of hospital stay and need for pediatric intensive care unit admission. By improving understanding of the hormonal stress response associated with febrile seizures, this study aims to contribute to the knowledge of seizure pathophysiology in childhood and may help identify biological factors associated with more severe clinical courses.
NCT07274410
Neonatal convulsions are seizures that occur during the first 28 days of a newborn's life. They are considered a medical emergency and often indicate an underlying problem in the brain, such as lack of oxygen at birth, infections, metabolic disturbances, or structural abnormalities. Many seizures in newborns are subtle and difficult to detect without careful clinical assessment. This study aims to determine how often neonatal convulsions occur among newborns admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children Hospital. It will describe how affected newborns present clinically, identify the main causes, and evaluate the early outcomes during hospitalization. The study is designed as a prospective cohort study. Newborns aged 0-30 days who are diagnosed with neonatal convulsions will be enrolled and followed throughout their stay in the NICU. Each patient will undergo full clinical evaluation and standard laboratory and imaging investigations, including blood tests, neuroimaging, and other tests as clinically indicated. The findings of this study will provide updated local data on the incidence, causes, and outcomes of neonatal convulsions in our region. This information may help improve early diagnosis, guide appropriate treatment, and enhance the quality of neonatal care.
NCT05096273
The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C) pain tolerance (time with hand in water) and cortisol response. Target assessments will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.
NCT04807933
Evaluation of the physiological and clinical effects of the biofeedback training with patients suffering from somatoform disorders, depending on their neurovegetative profile related to a visceral-brain decoupling.
NCT06676020
The research will be conducted to determine the effect of the training given to parents/caregivers on their knowledge, attitudes, practices and anxiety towards preventing febrile seizures in children. The research will be carried out as a randomised controlled experimental design in the Pediatric Emergency Department of Zeynep Kamil Women's and Children's Diseases Training and Research Hospital between October 2024 and October 2025.
NCT05670509
A randomized controlled clinical trial comparing patient/ ER physician satisfaction and ease of administration of 3 non IV routes of midazolam as a rescue medication for seizure control. Study population included children with known seizure disorder who were prescribed midazolam by pediatric neurologist at home and those presenting to ER with following inclusion and exclusion criteria
NCT06181383
If the seizure is clinically evident and prolonged, the most common first-line agent utilized is phenobarbital.(Glass et al;2016) ,Its mechanism of action is the synaptic inhibition through an action on GABA receptors, It can not only control seizures but also reduce the metabolism of the brain .(Geneva;2011) ,Phenobarbital can control 43-80% of electrical seizures (abnormal electroencephalograms) in newborns.(Sharpe et al;2020) Levetiracetam can also be used for treatment of neonatal seizures, which is safer than phenobarbital, it's mechanism of action is modulation of synaptic neurotransmitter release through binding to the synaptic vesicle protein SV2A in the brain, with less side effects on cognitive development in the levetiracetam treated subjects.(maigre et al;2013)
NCT01431326
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
NCT05860153
The American Academy of Pediatrics (AAP) in 2011 published a clinical practice guideline defining a febrile seizure as "a seizure accompanied by fever (temperature ≥ 100.4°F or 38°C by any method), without central nervous system infection, that occurs in infants and children 6 through 60 months of age." Febrile seizures are further classified as simple (generalized in onset, last less than 15 minutes, and do not occur more than once in 24 hours.) or complex (FS duration longer than 15 min, repeated convulsions within the same day, and focal seizure activity or focal findings during the postictal period.).
NCT05322772
Convulsion is a common pediatric disorder and there is strong relation between convulsion and cardiovascular system which revealed by ECG monitoring and there are many ECG abnormalities attributed to different causes of convulsions, A 12-lead ECG is a low-cost test and can detect clinically significant abnormalities such as long QTc interval or heart block. Doing an ECG in all patients presenting with seizures clinic, inevitably, pick up non-specific abnormalities which require further investigation. Moreover, a normal 12-lead ECG does not exclude a cardiovascular cause for collapse and for those in whom a cardiac cause is still suspected despite a normal ECG, referral to a cardiologist is advisable
NCT04364321
To study the efficacy and safety of single dose clonazepam compared with intermittent oral diazepam for prevention of recurrent febrile seizures in children who had three or more febrile seizures.
NCT03369093
Burden: Pneumonia remains the leading infectious cause of death accounting for 920,000 children under five around the world. This means a loss of over 2,500 child lives every day, or over 100 every hour. Since 2000, the number of child deaths caused by pneumonia has decreased by 47 percent. The tremendous progress made is due in part to the rapid roll-out of vaccines, better nutrition, and improved care-seeking and treatment for symptoms. However, pneumonia hasn't declined as quickly as other diseases such as malaria (58%), HIV/AIDS (61%), and measles (85%). Knowledge gap: The Lancet Series on Childhood Pneumonia and Diarrhea has reported that case management is one of the three most effective interventions to reduce pneumonia deaths in children. It is also noted that the cost-effectiveness of these interventions in the national health system needs urgent assessment. It was suggested to find out means to reduce hospital stay without compromising the quality of care. Relevance: The main purpose of the study is to compare the efficacy of two doses of parenteral Amoxicillin plus single-dose Gentamicin compared to four doses of parenteral Ampicillin plus single-dose Gentamicin. After 72 hours of treatment injectable Amoxicillin or injection Ampicillin will be switched to or replaced by oral Amoxicillin and will be discharged with an advice to attend to Ambulatory Care Unit (ACU) to receive a once-daily dose of injection Gentamicin for a total of 5 days. It is anticipated that this modified therapy will reduce the hospitalization stay of children with severe pneumonia and would therefore be relevant in countries with the resource-poor settings. By reducing the hospitalization period, this therapy has the potentials to reduce hospital-acquired infection. Hypothesis (if any): Rate of treatment failure with two doses of injectable Amoxicillin plus single-dose Gentamicin will be no more than that of four doses of injectable Ampicillin plus single-dose Gentamicin in the management of children between 2 months to 59 months hospitalized for WHO classified severe pneumonia.
NCT03013348
A retrospective validation study of a post-processing method intended to identify psychogenic nonepileptic seizures
NCT02598076
All subjects will attend an initial clinic visit with the neuropsychiatrist and epileptologist. At the end of this visit, those subjects randomized to motivational interviewing will be questioned using standardized motivational interviewing techniques by the study author who is a board certified neurologist and who will have formal training and certification in motivational interviewing. Those subjects randomized to the control group will also undergo an initial clinic visit with a neuropsychiatrist and neurologists. However they will not undergo any subsequent motivational interview. Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing psychotherapy for treatment of PNES at Brigham and Women's Hospital or referred to a local psychotherapist according to their preference. All subjects will be contacted by phone at 3 month follow-up. If necessary they will be called 5 times at various times during the day and early evening. If they are not reached, they will receive a letter requesting them to contact the study staff to complete the study. Subjects will be questioned about their adherence to treatment. The primary outcome will be the number of psychotherapy sessions for the treatment of PNES in which they have participated over the past three months. They will also be assessed for secondary outcomes including dichotomous adherence (either seizure freedom or active participation in psychotherapy for the treatment of PNES, with more than 5 sessions over the past 3 months), seizure frequency over the past month, number of hospitalizations and emergency department visits over the past 3 months, and quality of life as measured by the brief QOLIE-10 instrument. For those patients who give permission, their psychotherapists will be contacted by study staff to confirm the exact number of psychotherapy sessions over the past 3 months. A standard Partners clinical records release form with the patient's signature will be sent to the therapist's office.
NCT01919307
This feasibility study will determine the tolerability of auricular acupuncture, compliance with self-reported seizure tracking, and the quality of a proposed sham acupuncture protocol to inform the design of a large, multi-center, placebo-controlled, double-blind study to demonstrate the therapeutic effect of auricular acupuncture for the treatment of Non-Epileptic Seizures.
NCT00835627
The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES) or combined treatment (CBT-ip + sertraline) will report fewer nonepileptic seizures (NES) compared to patients who receive community care / treatment as usual (TAU). The purpose of this study is to provide pilot testing and data to inform the future multicenter randomized controlled trial based on the hypothesis.
NCT01931813
This project is the pilot step necessary to develop a system of vaccination pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for this challenge and case series analysis, with the use of linked medicoadministrative data for hospitalisations the reimbursement of healthcare costs. This linkage of medicoadministrative data is new in France. The example of the risk of hospitalisation for febrile convulsions in infants less than two years old following vaccination against diphtheria, tetanus and pertussis is given as the reference association. This choice is justified by the numerous publications over many years on the existence of this association (Miller et al BMJ 1981, Farrington et al Lancet 1995). In addition, as case series analyses have been carried out to assess this risk, the results can be compared directly (Lancet 1995). The study to determine whether the analysis tools are suitable for the data will be tackled at the following levels: * Validity of the selection of cases from administrative records alone using coding based on the international classification of diseases ICD10 * Validity of the risk assessment. This methodology feasibility project must make it possible to identify the different potential problems. This is a prerequisite necessary for the systematic implementation.
NCT00456391
Pediatric patients are admitted to the emergency room for diverse causes, beside trauma, patients can present with convulsions, suspicion of brain tumor or increased intracranial pressure. In most of the cases a brain CT is performed even before physical examination by a skilled neurologist. The amount of radiation that the children are exposed is equivalent to 100 plain chest X rays. The purpose of this tudy is to examinate in a retrospective study what were the indications for CT study and what was the incidence of relevant abnormal findings that required emergency intervention or referral.