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Epilepsy clinical trials

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NCT ID: NCT06412653 Not yet recruiting - Epilepsy Clinical Trials

Prospective Pilot Trial to Address Feasibility and Safety of Oral Zinc in GNAO1 Associated Disorders

ZINCGNAO1
Start date: June 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein G(o) subunit alpha (GNAO1) associated disorders. The main questions it aims to answer are: - Is a daily oral therapy with zinc in GNAO1 associated disorders a safe and feasible therapy? - Are there potential changes in general motor skills, general behaviour and well being, day/night rhythm, level of dyskinesia and dystonia, frequency of seizures, quality of life and changes in the microbiome of the patients. Participants with GNAO1 associated disorders will be given an oral zinc therapy for 6 month and will be assessed in 3 visits and 2 phone calls within this trial.

NCT ID: NCT06408428 Not yet recruiting - Epilepsy Clinical Trials

Glioma Intraoperative MicroElectroCorticoGraphy

MicroECoGG
Start date: September 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to validate the safety and to assess the quality of the signals provided by newly developed micro ElectroCorticoGraphy electrodes, provided by the company Panaxium, based on conductive polymers (PEDOT:PSS) in patients suffering of gliomas during resection surgery performed in awake condition. The main questions it aims to answer are: - Safety of PEDOT:PSS microECoGs by assessing the rate of serious adverse events associated with their use during glioma surgery. - Quality of PEDOT:PSS microECoGs recordings, as compared with recordings with traditional macroelectrodes, assessed by signal-to-noise ratio, impedance, ability to detect ripples (100-250 Hz) and fast ripples (250-600 Hz), ability to record epileptic activity (spikes and equivalent) either spontaneously or following direct electrical stimulation (afterdischarges). - Practicality of microelectrodes use as perceived by neurosurgeons. - Exploratory objectives: ability to record multi-unit activity, correlation between microECoG activity and tumor infiltration - local oncometabolite concentrations, determination of epileptic seizure rate during electrode use. Participants will be recorded during awake glioma surgery by the newly developed micro ElectroCorticoGraphy electrodes and by routine macroelectrodes, as standard of care during both mapping of cortical activities and electrical stimulations used to assess the functional mapping mandatory for tailored tumor resection.

NCT ID: NCT06402526 Not yet recruiting - Anxiety Clinical Trials

Evaluating the Efficacy of a Mobile Epilepsy Education Application

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Background. Following a childhood diagnosis of epilepsy, children and their families encounter significant concerns about the disease trajectory, side effects of anti-seizure medications, and long-term prognosis. The multitude of uncertainties can cause significant anxiety in the family, often within the context of limited supports and resources. Epilepsy education can help address these concerns, mitigating the development of anxiety, ultimately leading to better patient-, family- and system-level outcomes. Globally, the MEEP is the only mobile application providing education, monitoring of symptoms, and tracking of medical appointments. The original MEEP was developed, tested, and integrated into practice in Turkey; the investigators will now evaluate the efficacy of an English and French version of the MEEP for families of children with epilepsy in Canada. A two-group, single-center, randomized controlled intervention trial with 1:1 allocation ratio will be conducted in the Pediatric Neurology Clinic of the Montreal Children's Hospital. Seventy-two caregivers of children with epilepsy (intervention=36, control= 36), aged 1-17 years and treated at the study site will be eligible. Family Introduction Form, Epilepsy Information Scale for Parents and Parental Anxiety Scale for Seizures will be used to collect data at baseline and 3 weeks post-delivery of the 7-week intervention. The MEEP consists of 2 parts. The first part entails the delivery of the educational content of the MEEP, and the second part consists of a "Parental Monitoring Section." Comparator. The control group will continue to benefit from the standard educational services provided by the study site.

NCT ID: NCT06401538 Not yet recruiting - Jeavons Syndrome Clinical Trials

BMB-101 in Epilepsy With Eyelid Myoclonia (EEM)

Start date: July 15, 2024
Phase: Phase 2
Study type: Interventional

The study is a pilot, open-label, study to test whether BMB-101 is safe and effective in reducing the frequency of seizures in subjects with Epilepsy with Eyelid Myoclonia (also called Jeavons Syndrome). The study will last up to 6 months. There will be a 1 month screening period, then 3 months on open-label BMB-101 including titration and tapering/washout periods, and then a 1 month follow-up period. There will be 7 clinic visits.

NCT ID: NCT06388707 Not yet recruiting - Epilepsy Clinical Trials

A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy

Start date: August 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE).

NCT ID: NCT06388577 Not yet recruiting - Parents Clinical Trials

The Effect of the Training Programme Based on the Health Promotion Model Given to Parents

Start date: May 13, 2024
Phase: N/A
Study type: Interventional

This randomised controlled study evaluates the effect of a training programme based on the Health Promotion Model developed for parents of children diagnosed with epilepsy on parents' level of knowledge about epilepsy, parents' general self-efficacy level, parents' health promoting and protective behaviours and the number of hospital admissions of their children. The hypothesis of this study is that education has an effect on these.

NCT ID: NCT06388512 Not yet recruiting - Epilepsy Clinical Trials

iMRI Prone Positioning Frame Design Feasibility Study

Start date: April 2024
Phase: N/A
Study type: Interventional

The goal of this study is to learn if the prototype adjustable prone positioning frame is a feasible design for use during neurosurgical procedures which utilize intraoperative magnetic resonance imaging (iMRI). The main questions it aims to answer are: - Is the prototype prone positioning device design feasible for use during neurosurgical procedures which utilize intraoperative MRI? - Does use of the prototype device place the patient at increased risk of complications compared to the standard positioning pads? Researchers will place patients in the prone position on the prototype device during neurosurgical procedures that utilize intraoperative MRI and observe for any problems with the positioning device or complications attributable to the positioning device.

NCT ID: NCT06387186 Not yet recruiting - Refractory Epilepsy Clinical Trials

Leucine Enriched Essential Amino Acid Powder as an Add-on to a Classic Ketogenic Diet in Refractory Epilepsy

Start date: April 2024
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability of a Leucine-Enriched Essential Amino Acid (LEAA) Powder as an add-on to a classic ketogenic diet (KD) in pediatric and adult patients with refractory epilepsy.

NCT ID: NCT06383689 Not yet recruiting - Clinical trials for Symptomatic Epilepsy

Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring

OPERA
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The notion of genuine placebo effects on epileptic seizure events (i.e., effects beyond methodological study artifacts) is incompatible with the standard model of epilepsy seizure genesis. In this single-blind controlled study, the effectiveness of a covered placebo on (1) the timing of the occurrence of a first epileptic seizure ("seizure pill") versus (2) the subjective well-being ("comfort pill") during pre-surgical video-EEG monitoring will be examined. It is hypothesized that a placebo effect on subjective well-being can be demonstrated, but that epileptic seizure events are not influenced by placebo.

NCT ID: NCT06380192 Not yet recruiting - Clinical trials for Developmental and Epileptic Encephalopathy

Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data

DEE-RETRO
Start date: May 1, 2024
Phase:
Study type: Observational

Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity. The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent.