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Epilepsy clinical trials

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NCT ID: NCT05868551 Not yet recruiting - Epilepsy Clinical Trials

Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study

Start date: June 1, 2023
Phase:
Study type: Observational [Patient Registry]

This is an exploratory case control study with the aim to compare the Onchocerca volvulus virome between persons with onchocerciasis-associated epilepsy (OAE) and persons with onchocerciasis but without epilepsy. The main question we want to address is: Is there a virus contained in the O. volulus worm that may have a pathogenic role in causing OAE. In Maridi County, South Sudan, 20 persons with OAE with onchocerciasis nodules, and 20 age- and village-matched controls without OAE will be enrolled in a nodulectomy study.The adult O. volvulus worms will be extracted from the nodules and a viral metagenomic study of the worms. The O. volvulus virome of persons with and without OAE will be compared.

NCT ID: NCT05865561 Not yet recruiting - Epilepsy Clinical Trials

Identification of Volatile Organic Compounds (VOCs) as Biopredictors of Epileptic Seizures

ICONE
Start date: February 2024
Phase:
Study type: Observational

The unpredictable nature of epileptic seizures places people with epilepsy under permanent psychological stress, which contributes significantly to a restriction in their quality of life. The possibility of predicting the arrival of epileptic seizures would allow, in addition to taking a preventive treatment if the risk of seizure is close, to prevent traumas and accidents linked to possible falls during seizures, to authorize driving for certain people with epilepsy and to reduce the costs of medical care. To date and to our knowledge, no seizure detection device has been commercialized. There are commercialized devices based on biometric sensors other than EEG, but these are strictly dedicated to the detection of seizures and do not allow the anticipation of seizures. Regarding prediction, current research seems to have difficulties in developing convincing algorithms. The only system used successfully in real time would require a device implantable in the brain, but this would raise problems of acceptability. In addition, 20% of people with drug-resistant epilepsy have psychogenic non-epileptic seizures (PNES). These are sometimes difficult to differentiate from epileptic seizures by people with epilepsy and their caregivers, and their management differs from that of epileptic seizures. The distinction between these 2 types of events should also be taken into account by these prediction/detection tools. From the field of biomedical detection dogs, there is currently a converging body of evidence supporting that people with epilepsy emit specific odors associated with seizure events. Trained dogs have been shown to be able to discriminate body odors sampled during or just after an epileptic seizure from those sampled from the same subjects in various contexts outside of a seizure. It was also shown that a seizure can also be predicted by the volatile organic compounds (VOCs) released by the patient (human volatilome); the olfactory signature being already detectable up to 3h before a seizure. Another study used trained dogs to confirm that they are able to detect a seizure by smell and that this olfactory difference is already detectable before a seizure. The human volatilome VOCs lead is particularly promising, notably for its non-invasiveness and for the pre-ictal precocity that prediction allows. But at the moment, the studies are too studies are too preliminary, with sample sizes too small to conclude on the inter-individual generalization of the odor, taking into account the type of seizure involved and the influence of other variables (e.g., gender, age, medications). Moreover, in order to develop a reliable and transportable electronic detection tool, the identification of the VOCs involved is necessary, since the choice of sensors (e.g., to constitute an electronic nose) depends on it. The objective of this study is to overcome these shortcomings, by aiming at the identification of the informative odor(s) associated with epileptic events during the pre-ictal, ictal and post-ictal periods, taking into account the type of seizures (focal seizures, secondary generalized focal seizures, primary generalized seizures - motor and non-motor) and the inter-individual differences.

NCT ID: NCT05844696 Not yet recruiting - Epilepsy Clinical Trials

Electrical Neuromodulation for Focal Epilepsy

Start date: May 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this research is to use electrical neuromodulation on patients with focal epilepsy. The main objective is to assess safety and observe potential therapeutic effects.

NCT ID: NCT05831371 Not yet recruiting - Alzheimer Disease Clinical Trials

Discard the Curative Causes of Late Onset Epilepsy: the Role of Brain 18F-FDG PET

EPITEP
Start date: May 2, 2023
Phase:
Study type: Observational

Etiology and cognitive prognosis in late onset epilepsy differ from young adults epilepsy. At the epilepsy onset, this is crucial to detect potential curative/treatable brain disorders. After classical investigation including morphological brain imaging, EEG, clinical assessment, which added value may have brain FDG PET in the diagnosis and prognosis evaluation?

NCT ID: NCT05803434 Not yet recruiting - Epilepsy Clinical Trials

Cannabidiol in Children and Young Adults With Rare Disease-associated Severe Epilepsy

CBD_RE
Start date: June 1, 2023
Phase: Phase 2
Study type: Interventional

This is a pilot, open-label, phase II study. The main objective of the study is to demonstrate that Cannabidiol (CBD), used in addition to current anti-seizure medications (ASMs) reduces the number and/or severity of motor (generalized, focal, or both) seizures in children and young adults with rare disease-associated severe epilepsy. Secondary objectives include assessment of safety and tolerability, changes in behaviour, cognition and sleep, pharmacokinetic interaction with concurrent ASMs.

NCT ID: NCT05794295 Not yet recruiting - Clinical trials for Temporal Lobe Epilepsy

Sleep Architecture & Intrinsic Oscillatory and Network Connectivity in Cognition and Executive Dysfunction in TLE

Start date: July 2024
Phase: N/A
Study type: Interventional

Temporal Lobe Epilepsy (TLE) patients and healthy controls will undergo a night of sleep at the UC Davis Epilepsy Monitoring Unit (EMU) to characterize sleep architecture. A subset of TLE patients will be randomly assigned to an Acoustic Stimulation (AS) or SHAM stimulation night and return at least 7 days later for the other condition. Cognitive tests will be conducted 90 minutes prior to sleep (learning and immediate recall) and again 1 hour after awakening for 120 minutes (delayed recall and attention), while monitoring neural networks using functional Magnetic Resonance Imaging (fMRI).

NCT ID: NCT05788159 Not yet recruiting - Epilepsy Clinical Trials

An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover, Oralcomparative Pharmacokinetic(PK)Study of Lacosamide Extended-Release Tablets , Adult, Human Subjects Under Fasting Conditions.

Start date: April 1, 2023
Phase: Phase 1
Study type: Interventional

An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover, Oralcomparative Pharmacokinetic(PK)Study of Lacosamide Extended-Release Tablets , Adult, Human Subjects Under Fasting Conditions. Main purpose: To the Overseas Pharmaceutical,Ltd. Developed lacoxamide slow-release tablets (specification: 100mg) for the test preparation, UCB produced rasoxamide tablets (trade name: VIMPAT®, specification: 50mg) for the reference preparation, compare the fasting state of oral test preparation and reference preparation in Chinese healthy subjects blood concentration and main pharmacokinetic parameters, to evaluate the biological equivalence of test preparation and reference preparation. Secondary objective: To evaluate the safety of the test sustained-release tablets and reference tablets in the healthy Chinese subjects.

NCT ID: NCT05704439 Not yet recruiting - Hypertension Clinical Trials

Cardiovascular Risk Reduction in Epilepsy

Start date: January 2024
Phase: N/A
Study type: Interventional

Epilepsy is a disabling and lethal neurological disease which affect 3.47 million Americans. Significant health care disparities exist in people with epilepsy (PWE). Hypertension and hyperlipidemia are highly prevalent and often go undertreated, and cardiovascular (CV) mortality is higher in people with epilepsy (PWE) than the general population. Preliminary data from our group shows that PWE have higher ACC-ASCVD risk scores than an age matched NHANES cohort without epilepsy. Preliminary data also demonstrate mortality rates in PWE due to hypertension, stroke, and diabetes are rising in the US, counter to the US general population. This proposal seeks to test the feasibility, acceptability, and preliminary efficacy of a new care model for the underserved PWE in a public health setting. In this new model, neurologists guided by standardized treatment algorithms (ACC-ASCVD estimator+) propose and initiate pharmacological interventions for hypertension and hyperlipidemia.

NCT ID: NCT05671575 Not yet recruiting - Epilepsy Clinical Trials

Study The Knowledge and Attitude Towards Epilepsy Among Relatives of People With Epilepsy and Their Impact on The Patient's Quality of Life

Start date: January 2023
Phase:
Study type: Observational

Epilepsy is a common neurological condition that affects personal and familial behavior and social support . About 50 million people worldwide suffer from epilepsy and the prevalence of active epilepsy in developing countries is 5 to 10 per 100 persons . Individuals with epilepsy may suffer from psychological issues such as depression, anxiety, and psychosis . Accordingly, living with a person with epilepsy will provide some challenges, particularly at home. Studies have reported that relatives of people with epilepsy have an increased risk of anxiety. Epilepsy can inflict an enormous burden on both the people with epilepsy (PWE) and their family caregivers, decreasing their quality of life and daily efficiency.

NCT ID: NCT05664854 Not yet recruiting - Epilepsy Clinical Trials

Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve

EITsVNS
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Electroceuticals is a new field in which the goal is to treat a wide variety of medical diseases with electrical stimulation of autonomic nerves. A prime target for intervention is the cervical vagus nerve as it is easily surgically accessible and supplies many organs in the neck, thorax and abdomen. It would be desirable to stimulate selectively in order to avoid the off-target effects that currently occur. This has not been tried in the past, both because of limitations in available technology but also because, surprisingly, the fascicular organisation of the cervical vagus nerve is almost completely unknown. The aim of this research is to investigate the functional anatomy of fascicles in the cervical vagus nerve of humans. This will include defining innervation to the heart, lungs and recurrent laryngeal and, if possible, the oesophagus, stomach, pancreas, liver and gastrointestinal tract. It will be achieved by defining fascicle somatotopic functional anatomy with spatially-selective vagus nerve stimulation (sVNS) and the new method of fast neural imaging with Electrical Impedance Tomography (EIT). EIT is a novel imaging method in which reconstructed tomographic images of resistance changes related to the opening of ion channels over milliseconds can be produced using rings or arrays of external electrodes. In humans, using a nonpenetrating nerve cuff with sVNS or fast neural EIT, this will be performed for 30 minutes transiently during an operation to insert a vagal nerve stimulator for treatment of epilepsy and deliver images in response to activity such as respiration or the electrocardiogram (ECG).