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Seizures clinical trials

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NCT ID: NCT04770337 Recruiting - Epilepsy Clinical Trials

Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

NCT ID: NCT04759196 Recruiting - Clinical trials for Chronic Subdural Hematoma

Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas

GENESIS
Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

Some patients with chronic subdural hematomas and transient neurological symptoms do not respond to standard antiepileptic drugs. The investigators think that some of them could have cortical depression rather than epileptic discharges. After an intensive literature review, the investigators found out that some antiepileptic dugs (Lamotrigine, Topiramate) were found to be efficient to treat cortical depression in other conditions (migraine, subarachnoid hemorrhage). In contrast, some other drugs (Levetiracetam) were not proved to be efficient. Knowing that, the investigators want to compare the efficacy of Topiramate against Levetiracetam in two different groups, the NESIS group (based on a NESIS score of 4 or more - increased risk of cortical depression) versus a non-NESIS group (score of 3 or less - increased risk of epileptic discharges).

NCT ID: NCT04756375 Completed - Sickle Cell Disease Clinical Trials

Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room

ReVCVO
Start date: March 4, 2021
Phase: N/A
Study type: Interventional

The management of pain in the emergency department is a major issue, especially for sickle cell patients who regularly consult for vaso-occlusive seizure (VOS). The place of virtual reality remains to be defined in a busy environment, in which the permanence of care generates a significant turn over of medical and paramedical personnel. With Its immersive nature, allowing the patient to detach from his immediate environment, wich is often stressful for patients, we can hope that in multimodal management, Virtual Reality (VR) can contribute to a faster reduction in pain with lower doses of morphine, but so far we have no data. Our pilot study aims to assess the effectiveness, feasibility and tolerance of adding virtual reality to the management of VOS in sickle cell patients in the ER.

NCT ID: NCT04737837 Not yet recruiting - Epilepsy Clinical Trials

A Real World Study on the Efficacy and Safety of Lacosamide as Add-on Therapy for Focal-onset Epilepsy

Start date: January 31, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this trial is to evaluate the efficacy, safety, and pharmaco-economics of Lacosamide Tablet as first add-on therapy for uncontrolled focal onset epilepsy ,invetigating effects of lacosamide Tablet on cognitive function of children and anxiety and depression of adults with focal onset seizures In real-world clinical setting

NCT ID: NCT04737369 Recruiting - Clinical trials for Traumatic Brain Injury

Multimodal Neuromonitoring

MMNM
Start date: December 1, 2020
Phase:
Study type: Observational

Theoretical Framework & Background Cortical spreading depressions (CSD) and seizures, are crucial in the development of delayed cerebral ischemia and poor functional outcome in patients suffering from acute brain injuries such as subarachnoid hemorrhage. Multimodal neuromonitoring (MMNM) provides the unique possibility in the sedated and mechanically ventilated patients to record these electrophysiological phenomena and relate them to measures of cerebral ischemia and malperfusion. MMNM combines invasive (e.g. electrocorticography, cerebral microdialysis, brain tissue oxygenation) and noninvasive (e.g. neuroimaging, continuous EEG) techniques. Additionally, cerebral microdialysis can measure the unbound extracellular drug concentrations of sedatives, which potentially inhibit CSD and seizures in various degrees, beyond the blood-brain barrier without further interventions. Hypotheses 1. Online multimodal neuromonitoring can accurately detect changes in neuronal metabolic demand and pathological neuronal bioelectrical changes in highly vulnerable brain tissue. 2. Online multimodal neuromonitoring can accurately detect the impact of pathological neuronal bioelectrical changes on metabolic demand in highly vulnerable brain tissue. 3. The occurrence and duration of pathological neuronal bioelectrical changes are dependent on sedatives and antiepileptic drug concentrations 4. The occurrence and duration of pathological neuronal bioelectrical changes have a negative impact on functional and neurological long-term patient outcome. 5. Simultaneous invasive and non-invasive multimodal neuromonitoring can identify a clear relationship of both methods regarding pathological neuronal bioelectrical changes and metabolic brain status. Methods Systematic analysis of MMNM measurements following standardized criteria and correlation of electrophysiological phenomena with cerebral metabolic changes in all included patients. In a second step neuroimaging, cerebral extracellular sedative drug concentrations and neurological functional outcome, will be correlated with both electrophysiologic and metabolic changes. Due to numerous high-resolution parameters, machine learning algorithms will be used to correlate comprehensive data on group and individual levels following a holistic approach. Level of originality Extensive, cutting edge diagnostic methods are used to get a better insight into the pathophysiology of electrophysiological and metabolic changes during the development of secondary brain damage. Due to the immense amount of high-resolution data, a computer-assisted evaluation will be applied to identify relationships in the development of secondary brain injury. For the first time systematic testing of several drug concentrations beyond the blood-brain barrier will be performed. With these combined methods, we will be able to develop new cerebroprotective treatment concepts on an individual basis.

NCT ID: NCT04737174 Withdrawn - Epilepsy; Seizure Clinical Trials

ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors

Start date: March 25, 2021
Phase: Phase 2
Study type: Interventional

Phase 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.

NCT ID: NCT04686786 Active, not recruiting - Seizures Clinical Trials

An Open-label Extension Trial of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures

Start date: December 8, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of CVL-865 as adjunctive therapy in participants with focal onset seizures.

NCT ID: NCT04650204 Terminated - Malignant Glioma Clinical Trials

Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy

Start date: December 4, 2020
Phase: Phase 4
Study type: Interventional

This phase IV trial studies the side effects and how well perampanel works in reducing seizure frequency in patients with high-grade glioma and focal epilepsy. Perampanel is a drug used to treat seizures. Giving perampanel together with other anti-seizure drugs may work better in reducing seizure frequency in patients with high-grade glioma and focal epilepsy compared to alternate anti-seizure drugs alone.

NCT ID: NCT04647825 Recruiting - Clinical trials for Automatic Seizure Detection

NEED: Neuromed Epilepsy EEG Database. A Large EEG Database of Epilepsy Patients for Research Community.

NEED
Start date: April 1, 2021
Phase:
Study type: Observational

For one-third of patients with drug-resistant epilepsy alternative approaches must be investigated in order to improve the quality of their life. A possible approach is to find automatic methods to detect/predict seizures, in order to adopt interventional actions to stop or abort the seizure or to limit its side effect. The main problem in this case is to evaluate the reproducibility of such methods and to standardize them, because there is a lack of availability of long-term electroencephalography (EEG) data. In this study we want to create a large long-term EEG database, called NEED (Neuromed Epilepsy EEG Database), whos aim is to give researchers a way to test their method in a large collection of data. The database will contain long-term EEG recordings of 200 patients as well as extensive metadata and standardized annotation of the data sets and will be made freely available for the download to the research community.

NCT ID: NCT04639310 Terminated - Epilepsy Clinical Trials

XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy

EPIK
Start date: March 29, 2021
Phase: Phase 3
Study type: Interventional

To investigate the potential antiseizure effects of adjunctive XEN496 (ezogabine) compared with placebo in children with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE).