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Refractory Epilepsy clinical trials

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NCT ID: NCT03570489 Terminated - Refractory Epilepsy Clinical Trials

Randomized Controlled Trial on Cardiovascular Exercise in Uncontrolled Epilepsy:

Epilepsy
Start date: November 30, 2018
Phase: N/A
Study type: Interventional

This is an open-label randomized controlled tria testing if an improvement in cardiovascular fitness can improve quality of Life and reduce seizure frequency in patients with refractory epilepsy.. Before the intervention each subject will undergo an evaluation of baseline cardiovascular fitness. Patients will be randomized into two groups One group will listen to a relaxation tape 5 days per week for 6 months and the other group will receive a ergometric cycle and perform a predetermined level of exercise per day , 5 days per week for 6 months. Randomization will be conducted an external randomization center based on a sequence of random numbers. Changes in concomitant antiepileptic drugs (AED) treatment during the study will be minimized, and restricted to AED changes deemed to be necessary to address AED-related toxicity. Medical examination; body weight; fitness test, including ECG and BP measurements, seizure frequency; adverse effects (unstructured interview); details of concomitant concomitant treatment, mood assessment by using the Hospital Anxiety and Depression Scale-Anxiety (HADS); health related quality of life (RAND-36), E4-data downloading, will be done at baseline and after 6 months Primary endpoint: Proportion of patients with at least 50% seizure reduction Secondary endpoints: Median percent reduction in seizure frequency, HADS score, RAND-36 score, fitness score; adverse events, changes in concomitant AED treatment, E4 data .

NCT ID: NCT03533530 Completed - Surgery Clinical Trials

Clinical Utility of ESI in Presurgical Evaluation of Patients With Epilepsy

CUESIPE
Start date: December 2, 2015
Phase: N/A
Study type: Interventional

This study evaluates to what extend electrical source imaging (ESI) provides nonredundant information in the evaluation of epilepsy surgery candidates. Epilepsy surgery normally requires an extensive multimodal workup to identify the epileptic focus. This workup includes Magnetic Resonance Imaging (MRI), electroencephalography (EEG) without source imaging, video monitoring and when needed Positron Emission Tomography (PET), Magnetoencephalography (MEG), Single Photon Emission Computed Tomography (SPECT) and invasive EEG recordings using implanted electrodes. ESI estimates the location of the epileptic source with a high sensitivity and specificity using inverse source estimation methods on non-invasive EEG recordings. This study aims to investigate the clinical utility of ESI using low-density (LD, 25 channels) and high-density (HD, 256 channels) EEG. Clinical utility is defined in this study as the proportion of patients in whom the patient management plan was changed, based on the results of ESI. Should ESI be added to the routine work-up of epilepsy surgery candidates.

NCT ID: NCT03404128 Completed - Refractory Epilepsy Clinical Trials

Long Term Follow-up of Hippocampal DBS for Refractory Epilepsy

Start date: January 11, 2016
Phase:
Study type: Observational

Follow up of the patients at Ghent University Hospital treated with hippocampal DBS for refractory epilepsy. Endpoints: - Long term evaluation of the effects of hippocampal DBS on seizure frequency and cognition - Evaluation of the satisfaction of patients and neurologist regarding the rechargeable DBS battery

NCT ID: NCT03331939 Terminated - Refractory Epilepsy Clinical Trials

Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition in Patients With Refractory Epilepsy

Start date: January 6, 2017
Phase: N/A
Study type: Interventional

The purpose of this investigation is data pilot study of the effect of theta frequency stimulation of the vagus nerve on cognitive performance in patients with refractory epilepsy. We will compare the effects of no stimulation, theta frequency (5 Hz), and 'standard' beta frequency stimulation (25-30 Hz) on cognitive measures. We hypothesize that theta frequency VNS will have a positive effect on memory retention. The goal of this study to provide initial data to inform the design of a larger clinical trial to examine the efficacy of theta VNS.

NCT ID: NCT03321240 Recruiting - Refractory Epilepsy Clinical Trials

Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia

SPREAD
Start date: January 15, 2018
Phase:
Study type: Observational

Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and reduced quality of life. Despite a major medical and socio-economic burden, rationale therapeutic strategies are still under debate. Surgical removal of the epileptogenic brain area (Epileptogenic Zone) is the most successful treatment, yet it fails to control FCD-associated seizures in as much as 40% of cases. Precise definition and complete resection of the Epileptogenic Zone are the main determinants of outcome. In current practice of French centers, up to 80% FCD-patients require an intracranial EEG (icEEG) recording to accurately define the epileptogenic zone. However, the indications for icEEG in MRI-visible FCD remain empirical and are essentially based on expert opinion.

NCT ID: NCT03196934 No longer available - Refractory Epilepsy Clinical Trials

Expanded Use of Cannabidiol Oral Solution

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

To allow subjects who have completed Insys 030 extension study to continue to take Cannabidiol oral solution.

NCT ID: NCT03115489 Withdrawn - Refractory Epilepsy Clinical Trials

Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus

Start date: May 4, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The study will investigate the efficacy of the N-methyl-D-aspartate receptor antagonist ketamine as a first line agent in refractory status epilepticus versus traditional general anesthetic agents used for burst suppression that target the gamma-aminobutyric acid adrenergic receptors.

NCT ID: NCT03062514 Recruiting - Refractory Epilepsy Clinical Trials

Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy

Start date: October 9, 2017
Phase: N/A
Study type: Interventional

Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

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: NCT02876289 Completed - Refractory Epilepsy Clinical Trials

Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)

PERLYON
Start date: May 2014
Phase: N/A
Study type: Observational

Perampanel is a non-competitive antagonist of the AMPA ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and safety of perampanel as add-on treatment in patients with refractory epilepsy. The investigators retrospectively collected and analyzed the data of patients with refractory epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD = 2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).