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Epilepsies, Partial clinical trials

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NCT ID: NCT03946618 Active, not recruiting - Epilepsy Clinical Trials

Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy

Start date: July 10, 2019
Phase: Phase 1
Study type: Interventional

Researchers are trying to determine if tracking seizure occurrence, seizure probability, behavioral state, cognition, and mood can be achieved using an implantable brain sensing and stimulation device (Medtronic RC+S Summit) coupled to an external, handheld, patient assistant device (PAD) with capability for patient interaction (patient data input). The system (RC+S & PAD) provides intracranial EEG (iEEG) sensing, electrical brain stimulation, and machine learning algorithms running on the RC+S and PAD that will be coupled with electrical brain stimulation (EBS) to prevent seizures and improve quality of life in patients with epilepsy.

NCT ID: NCT03916848 Active, not recruiting - Epilepsies, Partial Clinical Trials

Novel Network Analysis of Intracranial Stereoelectroencephalography

NNAIS
Start date: June 16, 2019
Phase: N/A
Study type: Interventional

Epilepsy is a disorder of the brain which is associated with disabling seizures and affects 100,000 people under 25. Many children with epilepsy also have a learning disability or problems with development. Although better outcomes occur in children who are successfully treated early for their epilepsy, 25% continue to have seizures despite best medical treatment. One potential treatment is a neurosurgical operation to remove parts of the brain that generate seizures. A proportion of these children have electrodes inserted into their brains as part of their clinical assessment, termed stereoelectroencephalography (SEEG), to help localise these regions. Subsequent surgery is not always successful - up to 40% of children will have ongoing seizures 5 years after surgery. The purpose of this study is to assess the utility of specially designed SEEG electrodes which can measure signals from single brain cells. These electrodes record the same clinical information as normal SEEG electrodes and are implanted in the same way, but can give the research team extra information at the same time. The investigators aim to assess whether studying the changes in the firing of individual cells, both during and between seizures, improves our ability to localise seizures and therefore improve outcomes following surgery. As part of this research project, the investigators will not be doing anything that is not already part of the normal investigation and treatment for these children. Children will be recruited to the study during routine outpatient clinic visits. Surgical planning and execution will not be affected. The electrodes are CE licensed for clinical use and do not alter the risks of the operation. Following the period of monitoring, the care of these children would not be altered in any way. The investigators aim to recruit 30 patients over 3 years. In addition to dissemination via scientific publications and presentations, the findings will be shared with participants and the public.

NCT ID: NCT03882151 Recruiting - Epilepsies, Partial Clinical Trials

Added Value of Automated Electrical Source Localization (EPILOG PreOp®) to Presurgical Evaluation of Refractory Epilepsy

EPILOG
Start date: January 15, 2019
Phase: N/A
Study type: Interventional

Drug resistant epilepsy is best managed by surgery. The goal of presurgical evalution is to correctly identify the epileptogenic zone, defined by the extent of cortical tissue that needs to be removed is order to achieve seizure freedom. When no causative lesion is identified, careful study of interictal activity is mandatory. Complementary analysis methods exist, designed to identify the source of electrical activity recorded with surface electro-encephalogram. While results are interesting in retrospective studies, the real clinical added value needs to be demonstrated with prospective studies. The company Epilog (Epilog, Ghent, Belgium) offers, with EPILOG PreOp®, a long-term EEG analysis to automatically detect epileptiform activity, combined with an estimation of the electrical source localization using a sLORETA inverse solution model. We will propose the EPILOG PreOp analysis to refractory epileptic patients with non-contributive cerebral imaging, under presurgical evaluation. By comparing the therapeutic decision with and without knowledge of the results of EPILOG PreOp®, we will establish the added clinical value of EPILOG PreOp®.

NCT ID: NCT03865771 Recruiting - Clinical trials for Benign Epilepsy With Centro Temporal Spikes (BECTS)

Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.

EPIMEM
Start date: March 27, 2019
Phase: N/A
Study type: Interventional

Age related focal epilepsies in children encompasses, according to the ILAE criteria, benign epilepsy with centro temporal spikes (BECTS), atypical benign partial epilepsy (ABPE) and epileptic encephalopathy with continuous spike and waves during sleep (ECSWS). These non structural epilepsies are associated with interictal sleep spike and waves activated by sleep. Moreover, high prevalence of learning disorders occur in children with age related epilepsies. A correlation is suspected between learning disorders and sleep activation of spike and waves. The investigators suppose that learning dysfunction is linked to loss of information during sleep of epileptic children, unlike for control patients. As sleep allows memory consolidation of words learned during wakefulness, an epileptic activity during sleep may disrupt this consolidation, leading to a loss of information. Hypothesis: the investigators hypothesize a disruption of memory consolidation after one night in children affected with ABPE and ECSWS (severe group) compared to memory consolidation in children affected with BECTS (benign group), and control group. Primary purpose: To demonstrate that the deficit of delayed recall in 15 word learning test after one night is higher for the "severe group", compared to the "benign group" and the control group. Secondary purposes: - to study the evolution over time of memory consolidation - to evaluate the correlation of the deficit of delayed recall with executive dysfunction, clinical factors of epilepsy, neurophysiological factors of epilepsy, and sleep architecture

NCT ID: NCT03803046 Terminated - Clinical trials for Cognitive Impact of Antiepileptic Drugs

Cognitive Impact of Benzodiazepin Withdrawn After Curative Epilepsy Surgery in Children With Focal Epilepsy

COGNIBENZO
Start date: September 9, 2019
Phase:
Study type: Observational

Epilepsy is a frequent group of diseases, affecting 1% of the general population with a higher incidence in children. Anti-epileptic drugs are used as part of the drug treatment. Even if children with epilepsy have its own characteristics, as in adults, the choice of an anti-epileptic treatment is also based on the benefit-risk balance. The purpose of the treatment should not only be the seizure control. The occurence of side effects is a major factor to be taken into account. In the special populatIon of children with resistant epilepsy (20 to 30% of epilepsy), the treatment goal is not any more to be seizure free but to achieve the lowest possible frequency of seizures with the lowest level of side effects. When assessing the benefit-risk balance of antiepileptic treatment, it is important to keep in mind that the child is a developing human being whose main activity is learning. Special attention should be paid to minimize treatments with excessive cognitive consequences. Be particularly wary of combination therapies (combinations of several antiepileptic treatments). Indeed, it is well established that they are more harmful than monotherapy. It is also important to avoid the use of drugs with too strong a cognitive effect. Some molecules such as phenobarbital or topiramate have been the subject of a few studies that have established their deleterious effect on the cognitive level. Among antiepileptics, benzodiazepines are sometimes used as disease-modifying therapy. In France, clobazam is the clonazepam have a Marketing Authorization for children. However, there is no study to determine whether these molecules have cognitive consequences. In order to have more data to better establish the risk-benefit balance of benzodiazepines in the treatment of children with epilepsy, the investigators wish to conduct work to evaluate the cognitive consequences of benzodiazepines in children treated for epilepsy.

NCT ID: NCT03796962 Active, not recruiting - Focal Epilepsy Clinical Trials

A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

X-TOLE
Start date: January 30, 2019
Phase: Phase 2
Study type: Interventional

The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).

NCT ID: NCT03738072 Recruiting - Epilepsy Clinical Trials

Intracerebral Electrical Stimulation and the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy

StiMiC
Start date: November 14, 2018
Phase: N/A
Study type: Interventional

Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies is of benefit for the definition of the seizure onset zone and hence for the presurgical planning.

NCT ID: NCT03712475 Completed - Fibromyalgia Clinical Trials

Pharmacokinetics of Two Formulation of Pregabalin

Start date: January 19, 2018
Phase: Phase 4
Study type: Interventional

A Randomized, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetic Profiles of Two Formulations of Pregabalin after Oral Administration in Healthy Volunteers under Fasting Conditions

NCT ID: NCT03689114 Active, not recruiting - Epilepsies, Partial Clinical Trials

Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)

STANDLOW
Start date: May 10, 2021
Phase: Phase 4
Study type: Interventional

There are no guidelines on the first maintenance daily dose of antiepileptic drugs (AEDs) in newly diagnosed, previously untreated epilepsy. Original trials and Cochrane reviews show that seizure remission can be achieved with differing daily doses. In clinical practice, the first maintenance dose varies significantly. In contrast, the risk of adverse treatment effects increases with dosage. There is thus the need to identify the lowest effective dose for treatment start. This background prompted us to undertake a randomized multicenter pragmatic non-inferiority trial comparing standard to low daily doses of AEDs to demonstrate that low doses are at least as effective as standard doses (as indicated by the national formulary) but are better tolerated and are associated with a better quality of life. If proven as effective as the standard dose, a low daily dose of AEDs is a benefit to the patient in terms of tolerability and safety and a source of savings for the National Health System.

NCT ID: NCT03644732 Recruiting - Refractory Epilepsy Clinical Trials

Atlas of Human Cognition by SEEG (MAPCOG-SEEG)

MAPCOG-SEEG
Start date: April 5, 2018
Phase:
Study type: Observational

The main objective of MAPCOG_SEEG is to create a database including brain recordings of cognition performed in clinical routine in patients during the pre-surgical SEEG assessment. This aims to be able to propose the first atlas of human cognition with a high temporal and spatial resolution.