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Epilepsies, Partial clinical trials

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NCT ID: NCT05273398 Completed - Epilepsies, Partial Clinical Trials

Effects of Diazepam on RNS Detections

Start date: March 1, 2022
Phase: Phase 4
Study type: Interventional

To assess the magnitude and duration of reduction in RNS recorded Detections and Long Episodes following intranasal administration of Valtoco®. All participants will have been implanted and treated with an RNS system for clinical purposes and regularly upload Detection and Long Episode data on a regular basis as part of regular clinical treatment. Participants will come to the clinic and be administered a single dose of Valtoco® via nasal spray. RNS recorded Detections and Long Episodes before and after Valtoco® administration will be compared. This is a pilot study, so all outcomes are exploratory.

NCT ID: NCT04061707 Completed - Epilepsies, Focal Clinical Trials

Subcutaneous EEG: Forecasting of Epileptic Seizures

SUBER
Start date: May 15, 2019
Phase:
Study type: Observational

Protocol Summary Population - Target population is 10 adults (18 to 75 years of age) with a diagnosis of treatment-resistant epilepsy with at least 20 seizures per year, and whose seizure onset recorded from scalp EEG is localized to a brain region accessible by the subcutaneous EEG electrodes Number of sites - Three sites; King's College Hospital NHS Foundation Trust, University College London Hospital NHS Foundation Trust, St George's University Hospital NHS Foundation Trust Study design - This study is an observational, non-randomised, non-interventional study. It is not intended as a device trial. It is not intended to assess the device performance, rather the usefulness of bio-signals in seizure prediction and in detecting seizure-associated phenomena. There will be no change to usual care as a result of taking part. A subcutaneous EEG device will be implanted under local anaesthesia to record continuous EEG and a non-invasive wrist-worn sensor will be used to acquire non-EEG bio-signals (eg. heart activity and rate, movements, muscle activity, electrodermal activity, body temperature) Objectives - The association will be investigated between non-invasive measurable variables related to stress and sleep, semi-invasive subcutaneous EEG phenomena, and the occurrence of seizures. The predictive value of change in non-invasive variables semi-invasive subcutaneous EEG phenomena for the occurrence of seizures will be assessed. Study Duration - Up to one year for each patient. Participants may be approached during or after this study to participate in related studies. Funding - This study receives funding from the Epilepsy Foundation of America, Innovative Medicines Institute (IMI) and UNEEG medical A/S.

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: NCT03607851 Completed - Focal Epilepsy Clinical Trials

Efficacy and Safety of Rapid Titration Protocols of Lacosamide

Start date: August 3, 2018
Phase: Phase 4
Study type: Interventional

Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide

NCT ID: NCT03446664 Completed - Epilepsies, Partial Clinical Trials

Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

Microburst
Start date: February 27, 2018
Phase: N/A
Study type: Interventional

Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.

NCT ID: NCT03283371 Completed - Clinical trials for Epilepsy, Focal Seizures, Partial Seizures

Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy

OPUS
Start date: March 20, 2018
Phase: Phase 2
Study type: Interventional

The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.

NCT ID: NCT03200769 Completed - Clinical trials for Sleep Apnea Syndromes

Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy

SASER
Start date: July 21, 2014
Phase: N/A
Study type: Interventional

Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency.

NCT ID: NCT03138876 Completed - Encephalopathy Clinical Trials

EEG Cap for Identification of Non-Convulsive Status Epilepticus

Start date: May 30, 2017
Phase: N/A
Study type: Interventional

Altered mental status (AMS) is one of the most common reasons for inpatient neurology consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour of seizure activity, making rapid identification and treatment of NCSE of great clinical importance. Currently, an electroencephalogram (EEG) technologist must be called in from home during non-workday hours in order to obtain a stat EEG. The investigators propose the time required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid placement of an EEG cap by the onsite neurology residents.

NCT ID: NCT03082222 Completed - Focal Epilepsy Clinical Trials

ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

Start date: July 2015
Phase:
Study type: Observational

This is a non interventional prospective study. Centers will enroll adult participants with partial onset seizures with or without secondary generalisation for whom the clinician has decided to initiate eslicarbazepine acetate (ESL) as an adjunctive therapy or monotherapy prior to the decision to take part in this study. Participants to be enrolled into the study will receive ESL either as an adjunctive therapy to one baseline antiepileptic drug (AED) or to at least two baseline AEDs or as monotherapy. Participants will be seen at baseline and at a follow-up visit after approximately 6 months to assess retention, efficacy, tolerability, quality of life (optional), and cognitive performances (optional).

NCT ID: NCT02898935 Completed - Focal Epilepsy Clinical Trials

Improvement of the Accuracy of Spatial Representation of Invasive Exploratory Electrodes in Focal Epilepsy

ELEC3D
Start date: November 25, 2016
Phase:
Study type: Observational

Reconstruction software allows visualization of cortical structure in 3 dimensions, showing on a single picture the position of all the electrodes. The EEG signal of each recording plot of the electrode is analyzed and compared with the underlying brain structure reconstructed by the software. It is therefore possible to visualize 1) ictogenic and epileptogenic areas using neurophysiological stereoelectroencephalography (SEEG) data and 2) adjacent functional cortical areas with functional imaging and SEEG. Software makes it possible to determine the links between these areas. This study aims to show that using these software is an asset in surgical decision and in the choice of surgical strategy. Each patient has presurgical evaluation (usual care), including morphologic and (if necessary) functional MRI, EEG and SEEG. In this study, software will be used to analyze the processed data (FSL software, FMRIB laboratory, Oxford University and BrainVisa/Anatomist. The surgical decision will be taken according to the usual staff procedures, based on the usual examination results. After the decision making process, the staff will be asked to reconsider the surgical decision, according to the analysis provided by the software. The discrepancies between the decisions will be recorded.