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Epilepsy clinical trials

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NCT ID: NCT05157737 Recruiting - Clinical trials for KCNQ2-related Epilepsy

Clinical Phenotype and Omics Study of KCNQ2-related Epilepsy

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

The aims of study on KCNQ2-related epilepsy: (1) establish phenotype database and sample database of KCNQ2-related epilepsy; (2) to establish genotype-phenotype association of KCNQ2-related epilepsy; (3) to study the brain network of KCNQ2-related epilepsy based on multi-modal brain image and EEG data; (4) to find prognostic biomarkers of KCNQ2-related epilepsy based on omics study.

NCT ID: NCT05140265 Recruiting - Epilepsy Clinical Trials

De-identified UNMH EEG Corpus Database Creation With Fully De-identified Clinical Information

Start date: October 11, 2021
Phase:
Study type: Observational

This proposal outlines the steps required for the creation of a pilot database of EEG recordings and de-identified medical records from patients internally referred within the UNMH Comprehensive Epilepsy Center. The UNMH EEG Corpus would be the first database of its kind. Other public databases contain either patient EEG signals or medical records, but without both kinds of information, it is impossible to relate pre-treatment neurobiomarkers with post-treatment prognosis. The database will also contain information that can improve seizure localization based off of scalp and intracranial EEG, and the requisite data for the creation of algorithms that forecast seizure activity; a development that could ultimately lead to novel responsive neural stimulation procedures that suppress seizures before they begin.

NCT ID: NCT05135091 Recruiting - Clinical trials for Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis

FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

Start date: June 16, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is designed to test whether a single stereotactic intracerebral administration of inhibitory nerve cells into subjects with drug-resistant mesial temporal lobe epilepsy is safe (frequency of adverse events) and effective (seizure frequency).

NCT ID: NCT05112107 Recruiting - Epilepsy Clinical Trials

Evaluation Of Strategies For Improving Ketogenic Diet Compliance

Start date: December 30, 2021
Phase: N/A
Study type: Interventional

In order to increase adherence to ketogenic diet treatment, palatability of meals and diversify the foods offered to patients a ketogenic kitchen will be created. Intervention: Incorporation of culinary workshops and supply of recipes for patients undergoing ketogenic diet treatment at Instituto da Criança - HCFMUSP.

NCT ID: NCT05104983 Recruiting - Epilepsy Clinical Trials

Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study

TSC-STEPS
Start date: October 13, 2021
Phase: Phase 2
Study type: Interventional

This trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants. This study is supported by research funding from the Office of Orphan Products Division (OOPD) of the US Food and Drug Administration (FDA).

NCT ID: NCT05101161 Recruiting - Parkinson Disease Clinical Trials

Neurofeedback Using Implanted Deep Brain Stimulation Electrodes

Start date: September 23, 2021
Phase: N/A
Study type: Interventional

Deep brain stimulation (DBS) has become a gold-standard symptomatic treatment option for Parkinson's disease (PD) and is also explored for a variety of other neurological disorders. The implantation of electrodes into deep brain areas has not only enabled the application of electrical stimuli, but has also provided researchers and clinicians with an unprecedented window to investigate aberrant neuronal activity right at the core of pathological brain circuits. Local field potentials (LFP) have already been readily investigated through externalised DBS electrode wires prior to internalisation and connection to an implantable neurostimulator. In the case of PD, motor symptoms have been evidenced to correlate with exaggerated beta oscillatory activity (13-35 Hz) in the LFP recorded from the subthalamic nucleus (STN). Firstly, beta activity recorded in the STN at rest in patients withdrawn from their medication has been correlated with the Unified Parkinson's Disease Rating Scale (UPDRS) across patients. Secondly, a reduction of signal power in the beta-band was correlated with clinical improvements of motor symptoms. Thirdly, the two main therapeutic strategies, the administration of L-Dopa, and high-frequency DBS both lead to a suppression of beta-synchronicity in the STN. Furthermore, beta-oscillations show fast and movement-dependent modulation over time and can serve as a biomarker and feedback signal to control the delivery of DBS. The investigators recently implemented deep brain electrical neurofeedback to provide real-time visual neurofeedback of pathological STN oscillations through externalised DBS electrodes and showed that PD patients were able to volitionally control and reduce subthalamic activity within a single 1 hour session. Moreover, neurofeedback-learnt strategies accelerated movements and could be retained in the short- and mid-term. Only recently, a newly developed neurostimulator, the Perceptâ„¢ PC (Medtronic Neurological Division, Minneapolis, MN, USA), has been clinically approved, which can not only apply electrical impulses, but also enable the measurement and transmission of brain activity. This neurostimulator is now the first choice for implantations at the University Hospital Zurich and is used for a variety of neurological disorders. The investigators' goal is to investigate whether neurofeedback through a fully implanted deep brain stimulation device is possible and can lead to a better control of pathological oscillations as well as symptom mitigation. Having shown that endogenous control over deep brain oscillations is possible, the investigators will also test this novel therapeutic approach for pathologies other than PD that are also treated with DBS. Neurofeedback using implanted DBS electrodes will have the advantage of enabling longer and multiple-day training sessions, which the investigators hypothesise to have a larger impact on control over pathological deep brain oscillations and neurological symptoms, as such a fully implanted neurofeedback system no longer requires the externalisation of DBS wires and is as such no longer limited to the first two days after electrode implantation. All in all, the investigators will not exceed a total streaming time of 7 hours per patients (7 d of battery time), which the investigators deem justifiable with respect to a battery life of > 5 years. This proposed research is highly significant as it will help our understanding of various neurological diseases that are highly prevalent in society (PD being, for instance, the second most common neurodegenerative disorder after Alzheimer's disease) and might culminate in novel, endogenous treatment strategies. The overall risk for patients is minimal to non-existent, as stimulation parameters are unaffected and the intended changes in brain activity are self-induced while DBS stimulation is off.

NCT ID: NCT05100771 Recruiting - Focal Epilepsy Clinical Trials

Optimized Volumetry in Radiology: Interest in Pediatric Brain MRI in the Exploration of Focal Epilepsy

ORACLE
Start date: March 14, 2022
Phase:
Study type: Observational

Multicentre cross-sectional study with prospective recruitment comparing the detection rate of lesions on brain MRI without and with quantitative volumetry and T1 relaxometry information during the management of children with suspected focal epilepsy.

NCT ID: NCT05085704 Recruiting - Epilepsy Clinical Trials

Brain Metabolism Observed at 7 Tesla

Start date: May 3, 2022
Phase:
Study type: Observational

The goal is to develop methodology to monitor flux in the citric acid cycle in brain via 13C nuclear magnetic resonance (NMR) spectroscopy at 7 Tesla.

NCT ID: NCT05082181 Recruiting - Epilepsy Clinical Trials

Telephone-Based Support Programs for People With Epilepsy

Start date: November 9, 2021
Phase: N/A
Study type: Interventional

This is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST). A sample of 120 English- and Spanish-speaking people with epilepsy (PWE) with elevated depressive symptoms will be enrolled. Both interventions are 8-week programs delivered in one-hour weekly sessions to groups of about 6 participants. Changes in depressive symptoms, quality of life and seizures will be assessed over 12 months. The trial will also examine mediators and moderators of treatment effects.

NCT ID: NCT05079971 Recruiting - Neonatal Seizures Clinical Trials

EAGLET: EEG vs aEEG to Improve the Diagnosis of neonataL Seizures and Epilepsy

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

The current project undertakes a prospective multicentre randomised controlled trial to evaluate whether full or continuous electroencephalography (cEEG) is superior to amplitude-integrated electroencephalography (aEEG) in the real time evaluation and diagnosis of neonatal seizures and in reducing time to treatment. At-risk new-born infants will be recruited on the participating neonatal intensive care units (NICUs) by trained specialist staff and will have 24 hours of EEG monitoring.