The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.
HyponatremiaMetabolic Bone DiseaseThe study investigates the association between normalization of serum sodium levels and bone markers in patients with epilepsy and chronic hyponatremia. The study is a randomized, single blinded, placebo controlled study where participants will be randomized to either treatment with salt tablets or placebo tablets through 4 months. At the beginning and end of the 4 months bone markers will be measured. The investigators null-hypothesis is that there will be no difference in bone markers before or after the intervention.
Promoting Implementation of Seizure Detection Devices in Epilepsy Care
Epilepsy in ChildrenThis is a multicenter home-based medical device intervention study, with prospective validation of the wearable seizure detection device (Nightwatch) and retrospective validation of remote sensors (video and audio detection) in children. The investigators will also perform a feasibility and utility analysis of Nightwatch.
GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
EpilepsyStudy to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin
Emotional Processing and Memory Evaluation in Epilepsy Patients
EpilepsyThe purpose of the study is to assess the effects of temporal lobe epilepsy (TLE) on memory and emotional functioning. The study will evaluate the known lateralized neurological dysfunction(Right TLE versus Left TLE) on emotional verbal and visual memory function. Study data will assess the ability of participants with known lateralized neurological dysfunction (Right TLE versus Left TLE) to differentially perceive emotional stimuli. Another component of the study will evaluate possible changes in memory function for emotionally charged material following right or left temporal lobectomy for the treatment of medically intractable epilepsy. It is expected participants with known lateralized dysfunction will exhibit differential ability to discriminate emotional charged visual and verbal material.
Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective...
EpilepsyThis is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.
ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic...
Epilepsy; SeizurePhase 2A single-arm exploratory clinical study in up to 12 adult subjects aged 18 and older with primary glioma, IDH1 mutation, and uncontrolled focal-onset seizure activity to determine the potential efficacy, safety and pharmacokinetics of ES-481 as adjunctive therapy in glioma-associated epilepsy and to assess for potential anti-tumorigenic effects.
The Impact of Mindfulness Meditation in Veterans With Epilepsy
EpilepsyEpilepsy is one of the fourth most common neurological disorder and affects people of all ages and about 25 % of those patients have medically intractable epilepsy. Since the traditional pharmaceutical and surgical approach is not always effective, this study intends to investigate a novel approach using mindfulness as adjunctive tool of treatment for veterans with epilepsy. This study proposes a randomized, single-blinded pilot investigative trial to assess the effectiveness of mindfulness meditation. The measures outcomes include seizure frequency, number of ER visits, quality of life, depression, anxiety, post traumatic stress disorder (PTSD), sleep quality and alcohol use in patients with Epilepsy. The cohort group will be randomized in two groups, one is the group of patients getting mindful meditation weekly during 8 weeks compared to patients in the waiting list who have the desire to participate.
Investigation of Human Epileptic Networks by fMRI
EpilepsyBackground: In the Emilia-Romagna Region approximately 19.000 people are affected by epilepsy. About 25% of epileptic patients are drug-resistant (DRE) and some of them are eligible for resective surgery of the epileptogenic zone (EZ). The precise EZ localization is crucial for a good surgical outcome. Intracranial EEG (icEEG) recordings remain the gold-standard to localise the EZ. New neuroimaging techniques, like simultaneous recording of functional MRI and EEG (EEG-fMRI), with advanced methodological approaches as effective connectivity analysis (i.e. Dynamic Causal Modelling-DCM) might improve the EZ localization. Objectives: (1) To develop a non-invasive protocol for the investigation of the epileptic network in patients with surgically remediable epilepsies; (2) To shed light on the patho-physiological mechanisms of drug resistance in DRE; (3) To provide a validation of effective connectivity applied to fMRI data in epilepsy. Methods: Two Research Units (RU1, RU2) will identify and characterize a cohort of DRE patients eligible for resective surgery. RU1 will be in charge to perform the EEG/fMRI coregistration and data analysis. RU2 will be responsible for the surgical resection of epileptic foci. IcEEG recordings will be performed at the Claudio Munari Epilepsy Center, Ospedale Niguarda, Milano. RU1&RU2 will evaluate the fMRI data results and compare with icEEG findings or expert's surgical decision. The principle measures of outcome are: (a) percentage of concordance of fMRI results with icEEG findings or electro-clinical features in term epileptic network identification; (b) percentage of concordance between DCM findings and EZ/IZ localization; (c) percentage of concordance of DCM findings with icEEG or electro-clinical features regarding the causal hierarchy within the epileptic network.
To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia...
EpilepsyPartialThis will be a multi-center, randomized, double-blind, placebo-controlled, crossover study to evaluate the effects of 2007/Fycompa (perampanel) on sleep, in subjects with well controlled partial onset seizures (on an antiepileptic drug [AED] monotherapy) who are experiencing sleep onset insomnia.
Treatment Resistant Epilepsy and N-Acetyl Cysteine
Autistic DisorderSeizures1 moreThis is a study to find out whether the dietary amino acid supplement, N-acetyl cysteine (NAC) is helpful in reducing the frequency of seizures in children with autism and comorbid epilepsy whose seizures are not responding well to usual medical treatment. The study is also looking to see if this supplement is helpful for immediate and ongoing treatment of symptoms of irritability. Additionally, this study will also look to see if certain substances in the blood that measure a specific type of stress on cells in the body can help tell us how NAC may be helping.