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Epilepsy clinical trials

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NCT ID: NCT02107989 Recruiting - Epilepsy Clinical Trials

Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database

Start date: March 11, 2014
Phase: N/A
Study type: Interventional

Objectives: The overall study objective is to compare the sensitivities and specificities of morphometric analysis techniques using structural MRI images based on pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy. To carry out these analyses, we aim to establish an age-stratified normative imaging database using healthy volunteers. Additional objectives are to identify abnormal networks in these patients using resting state fMRI/EEG and MEG/EEG, and to use language and memory fMRI tasks to examine the effects of epileptogenic zones and surgery on cognitive function and the networks associated with these functions. Study population: 300 adults and children (age 8 and older) with uncontrolled focal epilepsy, and 200 age-stratified healthy volunteers. Design: A retrospective and prospective natural history study. Research procedures for patients in this study include neuropsychological testing and 1-4 MRI sessions during presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing approximately 12 months post-operatively. Research testing (such as research neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical testing whenever possible, likely reducing the number of required visits. Patients will also have optional MEG and 7T structural imaging. Data will also be obtained from patients who have already undergone epilepsy surgery if they had procedures as outlined in the protocol and are willing to share the data. Healthy volunteers will receive a subset of the pre-operative procedures for patients, requiring at least 3 visits. In order to ensure adequate data acquisition, subjects may be re-scanned up to three times for the portions of the study in which they participated, possibly requiring additional visits. Outcome measures: The main outcomes will be establishment of normative values for morphometric analysis methods in age-stratified normal controls, and comparison of the sensitivity and specificity of these measures to pre- and postsurgical localization of the epileptogenic zone. Secondary outcome measures will include determination of the sensitivity and specificity of source localization using MEG/EEG and resting state fMRI/EEG, and to evaluate changes in activation during rest, as well as language and memory fMRI tasks in patients pre- and postsurgically, to examine the effects of epileptogenic zones and surgery on cognitive function and the networks underlying these functions.

NCT ID: NCT02100644 Completed - Epilepsy Clinical Trials

Valproate Dose Reduction and Its Clinical Evaluation by Introducing Lamotrigine in Japanese Women With Epilepsy - Single Arm, Multicenter, and Open-label Study

Start date: April 12, 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine whether the VPA (Valproate) dose can be reduced by additional administration of LTG (Lamotrigine) in Japanese pre-menopausal female epilepsy patients aged 15 years or older, whose seizures are well controlled by VPA monotherapy.

NCT ID: NCT02100501 Completed - Epilepsy Clinical Trials

Prospective Study of Comparison Between the Modified Atkins Diet and Classic Ketogenic Diet for Intractable Childhood Epilepsy

Start date: March 2011
Phase: N/A
Study type: Observational

The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually 3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to propose a less restrictive dietary treatment that would be more palatable to children and adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30% protein, and 10% carbohydrates by weight), without any restriction on the recommended daily calories. Some literature suggested that the MAD is an effective treatment for refractory epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD. The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled patients were randomly assigned to either one of two groups; the KD group and MAD group. The patients were required to attend outpatient clinic after 1, 3month to record their seizure frequency and severity, while their dietary treatment.

NCT ID: NCT02098941 Recruiting - Epilepsy Clinical Trials

Evaluate Retention Rate of Topiramate, Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment

Start date: March 2014
Phase: N/A
Study type: Observational

The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment.

NCT ID: NCT02098759 Recruiting - Epilepsy Clinical Trials

Long-term, Prospective Study Evaluating Clinical and Molecular Biomarkers of Epileptogenesis in a Genetic Model of Epilepsy - Tuberous Sclerosis Complex

EPISTOP
Start date: November 2013
Phase: N/A
Study type: Interventional

The primary objective of clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC. Secondary objective of the clinical part of EPISTOP is to compare the effects of standard antiepileptic treatment in patients diagnosed as having epilepsy after clinical seizures vs after electroencephalographic epileptiform discharges, in a randomized trial in TSC patients.

NCT ID: NCT02097355 Completed - Depression Clinical Trials

Using an Online Patient Monitoring System to Improve Care for Children With Chronic Conditions

TriVoxHealth
Start date: December 2014
Phase: N/A
Study type: Interventional

TriVox Health is an online system designed to make it easy for healthcare providers to monitor patients' disease symptoms and functioning over time and in between in-person visits (http://www.youtube.com/watch?v=VR1vcbx0Ef4). Using combined quality improvement and randomized clinical trial methods, we will evaluate the impact of TriVox on the health outcomes, patient/family experience of care, and healthcare utilization for children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD), asthma, autism, depression, and epilepsy.

NCT ID: NCT02091375 Completed - Epilepsy Clinical Trials

Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)

Start date: March 30, 2015
Phase: Phase 3
Study type: Interventional

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

NCT ID: NCT02091206 Completed - Epilepsy Clinical Trials

A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)

Start date: October 22, 2014
Phase: Phase 2
Study type: Interventional

To evaluate the safety and pharmacokinetics (PK) of multiple doses of GWP42003-P compared with placebo in children with Dravet syndrome.

NCT ID: NCT02090569 Terminated - Clinical trials for Partial Drug-resistant Epilepsy

High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery

ULYS
Start date: April 7, 2014
Phase: N/A
Study type: Interventional

High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery (ULYS)

NCT ID: NCT02089243 Not yet recruiting - Epilepsy Clinical Trials

Controlled Randomized Vagus Nerve Stimulation (VNS) Therapy Versus Resection (CoRaVNStiR)

CoRaVNStiR
Start date: June 2014
Phase: N/A
Study type: Interventional

Background: There are a variety of treatment options for medically refractory medial temporal lobe epilepsy. Evidence from randomized trials indicates vagus nerve stimulation therapy can be used as a proven therapy for medically refractory medial temporal lobe epilepsy. Resective surgery is one of the most commonly used methods to treat medically refractory medial temporal lobe epilepsy. The aim of this study is to compare the effects of vagus nerve stimulation therapy and resective surgery in the treatment of the medically refractory medial temporal lobe epilepsy. Methods/Design: In this article, we report the design and protocol of a randomized controlled trial to treat medically refractory medial temporal lobe epilepsy with vagus nerve stimulation therapy or resective surgery. In total, 40 patients aged 12 to 60 years with medically refractory medial temporal lobe epilepsy will be assessed. There are two treatment groups. These patients are randomly assigned to be in one of the following two treatment groups, i.e. 1) undergo temporal lobe resection group, 2) receive vagus nerve stimulation therapy group. The primary outcome is to assess whether vagus nerve stimulation produces a reduction in mean monthly seizure frequency that is comparable to resection at 3 months, 6 months, 9 months and 12 months of follow-up. The secondary outcomes include the neuropsychological, seizure severity, seizure type, quality of life, mood assessment, operative and postoperative complications and long-term side effects, compared to resection. Discussion: The result of this trial will assess the efficacy of using vagus nerve stimulation therapy or resective surgery to treat medically refractory medial temporal lobe epilepsy, and to determine a better therapy for treating medically refractory medial temporal lobe epilepsy.