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Epilepsy clinical trials

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NCT ID: NCT03052998 Completed - Epilepsy Clinical Trials

Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy

OAETREAT
Start date: October 1, 2017
Phase: Phase 4
Study type: Interventional

Many studies have reported an association between epilepsy, including Nodding Syndrome (NS), and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or insufficiently controlled with mass Ivermectin distribution. There is evidence that increasing the coverage of Ivermectin reduces the incidence of epilepsy and anecdotal evidence suggests a reduction in seizure frequency in onchocerciasis associated epilepsy (OAE) patients who receive Ivermectin. Finding an alternative treatment for epilepsy in these patients will have major consequences. Objective To assess whether Ivermectin treatment decreases the frequency of seizures and leads to seizure freedom in OAE patients, including patients with NS. If we are able to demonstrate such an effect this would be an extra argument that Onchocerciasis is causing epilepsy and that therefore we should increase our efforts to eliminate onchocerciasis. Methods We will conduct a randomized clinical trial in the Democratic Republic of Congo (DRC) to compare seizure freedom in onchocerciasis infested epilepsy patients who receive immediate Ivermectin treatment with delayed (after four months) Ivermectin treatment. All participants will simultaneously receive anti-epileptic drugs (AEDs) according to local guidelines for epilepsy treatment. The primary endpoint is seizure freedom defined as no seizures during the fourth month of follow-up. Secondary endpoint is significant (>50%) seizure reduction compared to baseline seizure frequency. Reduction of seizures will be compared between Ivermectin and non-Ivermectin arms. Current status Start of enrolment is planned from March 2017 and we expect to have enrolled all 110 participants by August 2017. Results are expected early 2018. Discussion If Ivermectin treatment, in addition to AEDs, is able to lead to seizure freedom or significantly reduces seizure frequency in OAE patients this will have major consequences for epilepsy treatment in Onchocerciasis endemic regions. Ivermectin is donated for free, and in non Loa-Loa endemic regions has negligible side effects. Reducing the burden of epilepsy will have a major impact on quality of life and socio-economic status of families with affected members in Africa.

NCT ID: NCT03050931 Active, not recruiting - Epilepsy Clinical Trials

Electrical Impedance Tomography of Epilepsy

Start date: May 30, 2017
Phase:
Study type: Observational

The purpose of this study is to determine if Electrical Impedance Tomography (EIT) can produce reproducible and accurate images in people with epilepsy compared to existing standards such as MRI, CT or EEG. Electrical Impedance Tomography is a relatively new medical imaging method, which has the potential to provide novel images of brain function. It is fast, portable, safe and inexpensive, but currently has a relatively poor spatial resolution. It produces images of the internal electrical impedance of a subject with epilepsy using rings of ECG like electrodes on the skin, intracranial electrode mats or deep electrodes implemented surgically as part of clinical assessment. EIT recording will take place in parallel with the routine recording on the ward. Following completion of the recording, the EIT images will subsequently be analysed and compared to other imaging data for accuracy.

NCT ID: NCT03041363 Completed - Epilepsy Clinical Trials

Treatment Development of Triheptanoin (G1D)

Start date: March 29, 2017
Phase: Phase 1
Study type: Interventional

To determine the maximum tolerated dose (MTD), as a percentage of calories consumed, of triheptanoin (C7 oil; C7) in a pediatric and adult patient population genetically diagnosed with glucose transporter type 1 deficiency disorder (G1D).

NCT ID: NCT03038191 Terminated - Epilepsy Clinical Trials

Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home

Start date: March 8, 2017
Phase:
Study type: Observational

Epilepsy is a group of neurological disorders characterized by propensity for spontaneous epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell activity in the brain. About 0.7-1% of the world population suffers from seizures. The most common treatment is based on seizure medications that enables about 2/3 of the patients to control their seizures. However, about 20 million patients worldwide, suffer from unpredictable seizures without remedy, and are resistant to medication. In this study EEG and other physiologic signals are collected using wearable sensors, from Epilepsy patients who are at risk of experiencing seizures. The collected signals will be used for developing algorithms that may identify pre-seizure and seizure related periods.

NCT ID: NCT03035513 Recruiting - Clinical trials for Cryptogenic Epilepsy

Diffusion Tensor Imaging in Epilepsy With Continuous Spikes and Waves During Sleep

POCS-DTI
Start date: January 2017
Phase: N/A
Study type: Observational

Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic encephalopathy. Even if the correlation between the severity of the epilepsy and the cognitive consequences is well established, the mechanisms involved in epileptic cognitive degradation are complex and poorly understood. In CSWS, there are many arguments for the implication of cortical and subcortical cerebral structures. Among them the thalamus seems to play a crucial role. In fact it is strongly implicated in the sleep and this function is determining for learning. Moreover, it is part of the propagation pathway of generalized forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but most of the time conventional MRI is normal. Despite few literature on CSWS, some studies reported abnormal functional connectivity especially in the thalamus. The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI) and tractography will be useful in CSWS to confirm the implication of a cortico-thalamo-cortical network showing an abnormal structural connectivity. The investigators will try to determinate if a particular thalamic nucleus is concerned and demonstrate a link between the disease severity (duration and cognitive consequences) and the importance of structural abnormalities. Using resting state functional MRI (fMRI), the investigators will also try to investigate the default mode network. Its implication was also suggested in the literature.

NCT ID: NCT03031028 Recruiting - Refractory Epilepsy Clinical Trials

Effect of Outpatient Classic Ketogenic Diet in Epileptic Children and Adolescent.

Start date: July 2016
Phase: Phase 2
Study type: Interventional

This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Investigators enroll a group of eligible epileptic children and adolescent who have been referred from epilepsy center to our clinic and prescribe them ketogenic diet.

NCT ID: NCT03024827 Active, not recruiting - Clinical trials for Epileptic Encephalopathy

Cannabidiol in Children With Refractory Epileptic Encephalopathy

CARE-E
Start date: April 26, 2017
Phase: Phase 1
Study type: Interventional

This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal Extract in a small group of children with refractory epileptic encephalopathy. The dosage of Cannabis Herbal Extract will be gradually increased over a four month time period.

NCT ID: NCT03021018 Completed - Epilepsy Clinical Trials

A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

Start date: February 6, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV) compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.

NCT ID: NCT03014752 Completed - Clinical trials for Epilepsy Intractable

Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy

Start date: September 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients in each group, and will receive the diet for three months on non-randomised basis. In the classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be established on outpatient setting, without fasting and gradually. The modified Atkins diet will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of carbohydrate plus protein.

NCT ID: NCT03014440 No longer available - Clinical trials for Drug Resistant Epilepsy

Study of Cannabidiol for Drug-Resistant Epilepsies

Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this study is to determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. There are only a few open label studies that have demonstrated the safety and tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies were performed either retrospectively or with varying cannabidiol preparations. There are no well-documented studies and completely analyzed data for pediatric epileptic patients.