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Epilepsy clinical trials

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NCT ID: NCT04102254 Withdrawn - Epilepsy Clinical Trials

Thalamic Stimulation for Epilepsy Study

Start date: January 7, 2023
Phase: N/A
Study type: Interventional

In this study, the investigator aims to perform cortical stereo electroencephalogram (sEEG) recordings during simultaneous anterior nucleus of the thalamus (ANT) recording and stimulation to better understand the following: 1) how the ANT is involved in various seizure types; 2) which cortical regions are modulated by established ANT stimulation patterns; and 3) how novel ANT stimulation patterns modify epileptogenic cortical activity. Together, this knowledge will advance ANT deep brain stimulation (DBS) therapy by providing a physiologic basis for patient selection for ANT DBS, while identifying brain signals and stimulation patterns that can be used to develop novel methods for ANT DBS. Up to 15 adult patients (18 and older) who present to Duke Neurosurgery for routine seizure localization using sEEG will be asked to enroll in this pilot study of ANT recording and stimulation. In the course of surgical epilepsy treatment, patients routinely undergo surgical placement of sEEG electrodes for the purposes of seizure localization. During this procedure, 2 additional leads will be placed in the ANT. These patients remain hospitalized for 7-14 days after sEEG placement, during which time their seizure medications are tapered. Concurrent video monitoring is performed while continuous neural recordings are made through the sEEG electrodes. Additionally, continuous recordings will be performed through the electrodes placed in the thalamus. Periodically, standard intermittent high-frequency stimulation (130 Hz, 90-ms pulse width, and 2 mA intensity) will be performed with a 60-s on and a 300-s off cycle after surgery. These standard ANT stimulation parameters are employed clinically. Data will include the sEEG recordings marked for ANT stimulation, any side effects, medications, past medical history (PMH), and tests/procedures during the hospital stay. Risks involved are as described for the standard depth electrode surgery with the addition of the possible side effects from the stimulation which include sensations of numbness and tingling, and possibly increased seizure activity.

NCT ID: NCT03876093 Withdrawn - Epilepsy Clinical Trials

Epilepsy-related Brain Tumors Register

Start date: October 1, 2018
Phase:
Study type: Observational

Epilepsy is defined by a cerebral disorder characterized by a lasting predisposition to generate epileptic seizures and by the neurobiological, cognitive, psychological and social consequences of this affection. The definition of epilepsy requires the occurrence of at least one epileptic seizure. 1% of the population suffers from epilepsy. The most common causes are genetic and vascular, 10% of epileptic syndromes are caused by a tumor. The incidence of brain tumors in people with epilepsy is approximately 4%. Among patients with brain tumor (s), the frequency of epilepsy is 30% or more depending on type of tumeur. 30-50% of brain tumors are revealed by an epileptic seizure and 10 to 30% of patients with brain tumor (s) will develop seizures during their evolution. The main objective is to evaluate the frequency of epileptic seizures according to the type of brain tumor.

NCT ID: NCT03657056 Withdrawn - Clinical trials for Low Intensity Ultrasound Pulsarions

Focused Ultrasound Neuromodulation for Treatment of Temporal Lobe Epilepsy

LIFUP
Start date: January 2022
Phase: N/A
Study type: Interventional

The aim of the proposed study is to assess the feasibility of using the BrainSonix BX Pulsar 1002 low-frequency and Low-Intensity Focused Ultrasound Pulsations (LIFUP) in human subjects suffering from intractable temporal lobe epilepsy. The patients selected will already be scheduled to undergo surgery for resection of the temporal lobe, and the investigational therapy will be applied to the temporal lobe at least one day prior to its scheduled removal. The study is intended to provide preliminary evidence of safety, and establish the feasibility of LIFUP treatment as evidenced by a modulation of the Blood-oxygenation level dependent (BOLD) signal in functional MRI (fMRI), and normal findings from histological examination of the resected brain tissue.

NCT ID: NCT03644082 Withdrawn - Epilepsy Clinical Trials

Computerized Cognitive Training for Patients With Epilepsy

Start date: December 2020
Phase: N/A
Study type: Interventional

This is a study on the effectiveness of computerized cognitive training for treatment of memory disorders in patients with epilepsy. Participants will be recruited from patients referred for neuropsychological assessment through the NYU Comprehensive Epilepsy Center's inpatient and outpatient services. Individuals meeting inclusion criteria will be screened for the presence of memory disturbance (defined by results of neuropsychological testing) and lack of exposure to any previous form of computerized cognitive training. All eligible subjects will be provided with an account for Lumosity with instructions to complete training modules 5 days per week for a total of 8 consecutive weeks. Outcomes will be evaluated through changes on the neuropsychological test battery.

NCT ID: NCT03636958 Withdrawn - Refractory Epilepsy Clinical Trials

Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Gliomas are primitive brain tumors frequently associated with epilepsy. In a significant number of these patients epilepsy is resistant to antiepileptic drugs. There are currently no recommendations for the management of these drug-resistant epilepsies associated with glioma. In addition, few studies have addressed the subject and no treatment appears to be superior to others in the literature for this indication. In addition, many antiepileptic drugs pose problems of tolerance or interaction with chemotherapy in these patients. Fundamental studies on glioma-associated epilepsies have shown that there is a major dysregulation of glutamatergic systems involved in epileptogenesis and tumor growth. Targeting this glutamatergic system seems particularly interesting from a physiopathological point of view. Perampanel is a recent antiepileptic treatment with a novel mode of action targeting AMPA glutamate receptors. It has been shown to be effective in patients with drug-resistant epilepsies. He has demonstrated his tolerance in these patients. He has obtained a marketing authorization and is therefore used in routine epileptology without serious problems of tolerance being reported. It is neither an inducer nor an enzyme inhibitor, avoiding the problems of interaction with chemotherapy and is used in a daily dose facilitating compliance. Therefore, there may be specific antiepileptic efficacy of perampanel in patients with glioma. Nevertheless, the only current data is limited to a retrospective study of 12 patients. The objective of this protocol is to evaluate the efficacy and safety of perampanel in patients with glioma with drug-resistant epilepsy. a prospective randomized study with two parallel arms: antiepileptic combination therapy with perampanel and antiepileptic combination therapy without perampanel (free choice of the practitioner). The main criterion of judgment will be the decrease of the monthly frequency of crisis. Secondary endpoints will assess tolerance, efficacy on responder rate (at least 50% decrease in seizure frequency), seizure severity (secondary generalization, loss of consciousness), and quality. patients' lives (quality of life questionnaires, side effects and anxiety / depression). The duration of participation per patient will be 23 weeks (6 weeks of baseline, 5 weeks of titration and 12 weeks of maintenance). The recruitment period will be 3 years. Investigators plan to recruit 120 patients. In the context of no recommendation in the management of these patients, superior efficacy of perampanel compared with other antiepileptic drugs is expected. This would allow targeted treatment in this population and confirm the tolerance of this treatment in these patients.

NCT ID: NCT03595072 Withdrawn - Epilepsy Clinical Trials

Assessment of Effect of Vagal Nerve Stimulator (VNS) on Electrocorticograms Recorded by Responsive Neurostimulator (RNS) in Patients With Drug Resistant Epilepsy

Start date: July 1, 2023
Phase:
Study type: Observational

This study will investigate whether a Vagal Nerve Stimulator (VNS) causes measurable desynchronization and reduces epileptiform activity, such as spikes and seizures, in electrocorticograms (ECOGs) recorded by a Responsive Neurostimulator (RNS) in patients who have both devices implanted. Specific aims of the study: 1. Evaluate the change in frequency of epileptiform discharges during active VNS stimulation compared to interstimulation baseline periods 2. Evaluate the change in frequency of seizures during active VNS stimulation compared to interstimulation baseline periods 3. Evaluate the change in the number of RNS activations during active VNS stimulation compared to interstimulation baseline periods 4. Evaluate the change in synchronization of background ECoG (electrocorticogram) during VNS stimulation compared to interstimulation baseline periods.

NCT ID: NCT03589755 Withdrawn - Epilepsy Clinical Trials

The Impact of Mindfulness Meditation in Veterans With Epilepsy

Start date: February 8, 2019
Phase: N/A
Study type: Interventional

Epilepsy is one of the fourth most common neurological disorder and affects people of all ages and about 25 % of those patients have medically intractable epilepsy. Since the traditional pharmaceutical and surgical approach is not always effective, this study intends to investigate a novel approach using mindfulness as adjunctive tool of treatment for veterans with epilepsy. This study proposes a randomized, single-blinded pilot investigative trial to assess the effectiveness of mindfulness meditation. The measures outcomes include seizure frequency, number of ER visits, quality of life, depression, anxiety, post traumatic stress disorder (PTSD), sleep quality and alcohol use in patients with Epilepsy. The cohort group will be randomized in two groups, one is the group of patients getting mindful meditation weekly during 8 weeks compared to patients in the waiting list who have the desire to participate.

NCT ID: NCT03522987 Withdrawn - Depression Clinical Trials

Anxiety and Depression in Epilepsy: A Pilot Treatment Study

Start date: May 2018
Phase: Phase 4
Study type: Interventional

As a potential solution to address high rates of depression and anxiety seen in epilepsy patients and poor mental health care access, this trial aims to carry out treatment for depression and anxiety directly in the epilepsy clinic. Patients that meet eligibility criteria, including significant symptoms of depression and/or anxiety, will be enrolled in the intervention. The intervention will consist of an initial prescription for an FDA-approved medication to treat depression/anxiety and telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The purpose of this pre-piloting limited study is to streamline recruitment, intervention and outcome assessment process in preparation for a randomized, controlled pilot of the intervention.

NCT ID: NCT03379272 Withdrawn - Epilepsy Clinical Trials

Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital

CONNECT
Start date: December 20, 2020
Phase: N/A
Study type: Interventional

The proposed study is designed to evaluate the performance of the Neuronaute in comparison with the gold standard EEG in patients with a regular appointment at the hospital. The design of this study is guided by two overriding factors : (i) epileptics disorders suspected or either (ii) epileptics already diagnosed. Volunteers will be asked to participate to this study. This study will enroll 35 outpatient subjects aged 18 to 85. Informed consent will be obtained from the patients, and assent from the subjects, prior to any form of assessment or intervention as part of the study. Patients will be submitted to the studied device record Neuronaute following by the gold standard EEG. A grid with all EEG activity recorded during the trial will be provided for evaluation after completion of the trial.

NCT ID: NCT03368469 Withdrawn - Depressive Disorder Clinical Trials

Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Depression

Start date: February 23, 2018
Phase: N/A
Study type: Interventional

The proposed study seeks to obtain preliminary signal of the tolerability and efficacy of transcranial direct current stimulation (tDCS) for depressive symptoms in a sample of adolescents with depression and epilepsy. Additionally, effects of tDCS will be assessed via electroencephalographic, cognitive, and psychosocial measures.