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Epilepsy clinical trials

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NCT ID: NCT04076449 Recruiting - Epilepsy Clinical Trials

Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy

CRESS
Start date: September 3, 2019
Phase:
Study type: Observational

Cerebral cavernous malformation (CCM)-related epilepsy (CRE) impairs the quality of life in patients with CCM. Patients could not always achieve seizure freedom after surgical resection of the lesion, suggesting an inadequate treatment and evaluation of the epileptogenic zone or network. Iron deposition in cerebral cavernous malformations has been postulated to play an important role in triggering CRE. Quantitative susceptibility mapping (QSM), as an optimal in vivo imaging technique to quantify iron deposition, is employed to analyze the iron quantity in CCM patients with epilepsy and further combined with brain structural and connectome analysis, to describe the difference between CCMs with and without epilepsy. In vivo biomarkers predicting CRE risk in CCM natural history and CRE control outcome after CCM surgical resection will be further identified to improve management strategy.

NCT ID: NCT04076410 Active, not recruiting - Eyeglasses Clinical Trials

Efficacy of Lenses in Abolishing Photoparoxysmal Responses

PPRs
Start date: February 20, 2021
Phase: N/A
Study type: Interventional

Background. Blue lenses that filter out red light have been proposed as a new therapeutic alternative for patients with PSE, such as the lens Zeiss Clarlet Z1. This lens only allows a small overall quantity of visible light, and particularly a minimum percentage of red light, to pass through. However, these characteristics entail two main pitfalls: reduced applicability in high- latitude regions and lack of transmission for the red and yellow colors. The latter would mainly expose patients to the other colors that compose the visible light, and particularly to the blue visible light. This exposure might be damaging for their eyes in the long term, as it has been reported in some studies. Aim. To determine whether four new lenses with different spectral characteristics are not inferior in efficacy to Z1 to reduce the PPRs in patients with PSE. Participants. Patients between 5-18 years with suspected or confirmed PSE, referred to the Neurophysiology Service at Birmingham Children's Hospital (BCH) for an EEG with IPS/pattern stimulation. Objectives & Outcomes: 1.A) Primary Objective: To evaluate the reduction/suppression produced by four new lenses in the PPRs shown by patients with PSE during an EEG with IPS/pattern stimulation, and compare it with the reduction provoked by the Z1 lens in the same individuals. 1. B) Primary Outcome: reduction/suppression in both the PPR and the standardized photoparoxysmal response range (SPR) for IPS and pattern stimulation. 2. A) Secondary Objectives: - To obtain feedback from the patients who acquire a pair of our lenses regarding tolerability, overall adherence to treatment and improvement in the quality of life. - Comparison of the reduction/suppression in the PPRs between our lenses and the Z1 lens in those retrospective patients with PSE seen between 2008-2017 at the Aston Brain Center. 2.B) Secondary Outcomes: - Mean score obtained in adherence to treatment, tolerability, reduction in seizure frequency and autonomy according to the patient/parents or carers satisfaction questionnaires. - Reduction/suppression in both the PPR and the standardized photoparoxysmal response range (SPR) for IPS and pattern stimulation in those patients recruited at the Aston Brain Center.

NCT ID: NCT04063007 Recruiting - Epilepsy Clinical Trials

Epigenetics and Gut Microbiota in Children With Epilepsy

EpiMICRO
Start date: August 15, 2017
Phase: N/A
Study type: Interventional

The ketogenic diet is a high-fat, low-carbohydrate diet used in the treatment of epilepsy. The diet can be an efficient treatment option in children with drug resistant epilepsy, with more than 50 % seizure reduction in about 40- 70 % of the patients. However, there is still a lack of knowledge regarding the mechanisms of action, how will respond to the treatment and potential adverse effects.

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: NCT04054453 Active, not recruiting - Epilepsy Clinical Trials

Prevention of Epilepsy by Reducing Neonatal Encephalopathy

PREVENT
Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to examine if a pragmatic, evidenced based and generalisable intrapartum care bundle involving birth companions and empowering mothers will reduce birth injury-related epilepsy at 18 months of age in India. The care bundle will have four key elements (interventions): (1) birth companion providing constant 1:1 care during labour and early perinatal period; (2) fetal surveillance during active labour by a nurse or midwife using a graphic display Doppler; (3) labour management by an electronic partogram with an 'alert' and 'nag' feature based on the current WHO guidelines; (4) brain oriented early newborn care with resuscitation where indicated. The care bundle will be evaluated using a prospective interrupted time series design, recruiting 80,000 women delivering in one of the three participating centres in south India, over two years. Accurate baseline data will be collected during the first year and the optimised care bundle will be introduced during the second year. All full term newborn infants admitted to the neonatal unit with perinatal brain injury during both periods, will have detailed assessments including video electroencephalography, and magnetic resonance imaging, and will be followed up until 18 months of age. Primary outcome is the number of infants with epilepsy (categorised per current ILAE guidelines) at 18 months of age expressed as per 1000 term livebirths. The investigators will use a segmented logistic regression to divide the time series into pre- and post-intervention segments, with the intervention date as the intersection between segments. The difference in the two segments will be quantified using the level (step change) and slope (trend change). The total duration of the study is four years including 24 months of recruitment and 18 months of follow-up.

NCT ID: NCT04048213 Recruiting - Clinical trials for Learning Disabilities

The Becoming of Children With Doose Syndrome

DOOSE
Start date: August 1, 2019
Phase:
Study type: Observational

Doose syndrome is a rare epileptic syndrome that can lead to learning difficulties and a poor quality of life. The goal of this study is to evaluate the evolution of epilepsy and its consequences on cognitive development and learning issues in children with Doose syndrome.

NCT ID: NCT04043572 Recruiting - Epilepsy Clinical Trials

The Biomarkers of Neurological Disease in Utero Study

BONDING
Start date: June 1, 2019
Phase:
Study type: Observational

Anti-epileptic drugs (AEDs) are potent teratogens associated with a spectrum of physical and neurodevelopmental anomalies to the exposed fetus. Particular risks include congenital malformations, impaired motor and cognitive functioning, autism and poorer educational attainment. Fetal exposure to drugs that bind to central nervous system targets as part of their therapeutic effect (e.g. neurotransmitter receptors and neuronal channels) appear to alter brain structure and function in both animal models and humans. Fetal magnetic resonance imaging offers an approach to investigate these effects in vivo, identifying biomarkers, defining the onset of abnormalities and dose response. Fetal MRI may offer risk stratification and identify patients that may benefit from intervention early in development. The overall aim of this study is to contribute to improving developmental outcomes following the inevitable exposure during treatment of maternal epilepsy. This novel study aims to explore the central nervous system with state-of-the-art non-invasive multimodal magnetic resonance imaging consistent with the University of Nottingham Precision Imaging Beacon, so as to improve outcomes in patients at risk of long term complex neuropsychiatric conditions.

NCT ID: NCT04028596 Completed - Depression Clinical Trials

Measuring Blood Flow in the Brain After Epileptic Activity

SYNAPSE
Start date: December 5, 2019
Phase: Phase 2
Study type: Interventional

In this clinical trial, postictal phenomena (i.e., headache, delirium) will be investigated after administration of acetaminophen and nimodipine in depressed patients receiving electroconvulsive therapy (ECT). Postictal phenomena are thought to result from decreased cerebral blood flow and decreased oxygen concentration in the brain. It is expected that acetaminophen and nimodipine will reduce these postictal phenomena, compared to no treatment, because they target these mechanisms.

NCT ID: NCT04023851 Completed - Epilepsy Clinical Trials

Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care

Start date: April 12, 2019
Phase:
Study type: Observational

The study is intended to evaluate the impact of mobile application on management and knowledge acquisition in patients with epilepsy.

NCT ID: NCT04020484 Completed - Quality of Life Clinical Trials

Making Mindfulness Matter© in Children With Epilepsy

M3Epilepsy
Start date: December 2, 2019
Phase: N/A
Study type: Interventional

Epilepsy is a debilitating condition characterized by spontaneous, unprovoked seizures. Up to 80% of children with epilepsy (CWE) may face cognitive, psychiatric, and/or behavioral comorbidities with significant unmet mental health needs. Mindfulness-based interventions may provide an ideal vector to target unmet mental healthcare needs in patients with epilepsy and their families. The investigators propose the Making Mindfulness Matter© (M3) program as an intervention to improve health related quality of life and mental-health for CWE and their parents. M3 is live-online parent and child program that incorporates mindful awareness, social-emotional learning skills, neuroscience, and positive psychology. This pilot RCT is needed to refine the implementation of the intervention to families with a child with epilepsy, and collect information pertaining to the feasibility and effectiveness of the intervention in preparation for a subsequent multi-centred trial across Canada. Note: Due to COVID-19, the format has been modified for online delivery (from community-based) and the intervention has been restarted.