17 Clinical Trials for Various Conditions
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.
The investigators propose that treatment of the comorbid disorders (depression, anxiety, and impulsivity) with sertraline in patients with lone psychogenic nonepileptic seizures (NES), will result in a decreased number of NES. The purpose of this study is to provide pilot testing and data to inform the future randomized controlled trial based on the hypothesis.
This study will explore how the mind and the brain work to cause movement symptoms or seizures in people who do not have a recognized neurological or medical disorder. The study includes a check for psychiatric disorders, symptoms and their severity; psychiatric and personality questionnaires; and neuropsychological testing. Normal, healthy volunteers, people who have movement symptoms not due to a brain or medical disorder and people who have seizures not due to epilepsy may be eligible for this study. All candidates must be 18 years of age or older. All participants have a medical history, physical examination and psychological evaluation, including completion of questionnaires. People with movement symptoms or seizures have a symptoms evaluation. Some participants also undergo neuropsychological testing, including questionnaires, pen-and-paper or computerized tests, and motor tasks.
Developed by researchers from the Centers for Disease Control and Prevention (CDC), Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a group telephone program designed to improve depression for people with epilepsy. Project UPLIFT uses evidence-based approaches of cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy to help people manage and prevent symptoms of depression. For people with psychogenic non-epileptic seizures, there are few treatment options for depression that address the relationship between mood and seizures. There is evidence that mindfulness-based therapy and cognitive therapy are both effective for people with non-epileptic seizures, both in treating depression and reducing seizure frequency. In this study, Project UPLIFT will be offered to patients with psychogenic non-epileptic seizures. Project UPLIFT is facilitated by a trained clinician to groups of 4-8 patients over the telephone. The group will meet at a regular time, once a week, for 8 consecutive weeks. Participants will be assigned to one of two groups: an immediate-treatment or a waitlist control group which will begin Project UPLIFT 3 months after enrolling in the study.
Altered mental status (AMS) is one of the most common reasons for inpatient neurology consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour of seizure activity, making rapid identification and treatment of NCSE of great clinical importance. Currently, an electroencephalogram (EEG) technologist must be called in from home during non-workday hours in order to obtain a stat EEG. The investigators propose the time required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid placement of an EEG cap by the onsite neurology residents.
This multi-site study will examine patients with epilepsy (ES) following head injury \[i.e., posttraumatic epilepsy (PTE)\] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.
Functional Neurological Disorder (FND/ Conversion Disorder) is a highly prevalent and disabling neuropsychiatric condition. Motor FND symptoms include Nonepileptic Seizures, Functional Movement Disorders and Functional Weakness. Clinical research across these motor FND subtypes, including research studies from the candidate's laboratory, suggest that these populations share many clinical and phenotypic similarities that warrant increased research integration. Furthermore, despite the prevalence of motor FND, little is known about the underlying pathophysiology of this condition, which is a prerequisite for the development of biologically informed prognostic and treatment response biomarkers. Across 3 published neurobiologically focused articles, the candidate proposed a framework through which to conceptualize motor FND. It is suggested that motor FND develops in the context of structural and functional alterations in neurocircuits mediating emotion awareness/expression, bodily awareness, viscerosomatic processing and behavioral regulation. The overall goal of this project is to comprehensively investigate structural and functional magnetic resonance imaging (MRI) biomarkers of prognosis across motor FND. Multimodal structural and functional MRI techniques (including voxel-based morphometry, cortical thickness, resting-state functional connectivity and diffusion tensor imaging tractography) will be used to systemically probe brain-prognosis relationships. Novel aspects of this proposal include the study of the full spectrum of motor FND, consistent with a trans-diagnostic approach.
This study is part of a series of studies that will explore how the mind and the brain work to cause episodes of uncontrollable shaking in people who have no known underlying brain or medical disorder. The study is conducted at NIH and at the Brown University Rhode Island Hospital. Healthy volunteers and people with functional movement disorders (FMD) or non-epileptic seizures (NES) who are 18 years of age or older may be eligible for this study. Patients with NES have 3 teaspoons of blood drawn. The blood is tested for two genes that are normally found in healthy individuals to see if they are found more frequently in patients with uncontrolled shaking. Patients with FMD have blood drawn for testing and also undergo functional magnetic resonance imaging (fMRI) to look at how the brain functions while the subject performs a specific task. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the scan, the subject lies on a table that can slide in and out of the scanner, a metal cylinder. The scan lasts about 60 to 90 minutes, during which the subject may be asked to lie still for up to 10 minutes at a time and to perform tasks, such as identifying the gender of faces shown on a screen. Healthy volunteers may have blood drawn for genetic testing or fMRI or both.
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.
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.
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.
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 correlated epileptiform activity). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of either ReACT or supportive therapy. 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 occur 7 days before treatment, 7 days after 12th treatment session, and 2 months after the 12th treatment session. Long term follow-up assessments will occur 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment.
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.
This research study is examining the effects of Retraining and Control Therapy (ReACT; an intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). Participants engage in 8 individual therapy sessions consisting of either cognitive behavioral therapy or supportive therapy. Healthy control participants also complete pre-questionnaires and two computer tasks.
The purpose of this study is to help providers develop an interdisciplinary treatment pathway for functional neurological disorder (FND) at University of Alabama at Birmingham (UAB), and will involve psychiatry, speech therapy, physical therapy, and occupational therapy. The study will also help providers to evaluate the treatment pathway and publish results regarding the process and outcomes.
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.
The purpose of this study is to design and test the safety and feasibility of virtual reality technologies and experiences of egocentric avatar embodiment in the application of physical and cognitive behavior therapy in functional neurological symptom/conversion disorder. Investigators hypothesize that patients will safely use and accept this modality of treatment and will show evidence of a decrease in symptom frequency.