Clinical Research Directory

A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position

The goal of this study is to assess the performance of a commercial sheet sensor in determining body position after generalized tonic-clonic (GTC) seizures. If a sheet sensor could accurately detect GTC seizures, this could be a step towards autonomously repositioning patients with the aid of a smart mattress. Primary Objective Milestones: Feasibility objective: Monitor 50 patients with the objective of capturing at least 20 GTCS events. Primary analytic objective: Achieve detection of anatomical landmarks with body position change within 5 seconds with an accuracy of 75% both interictally and post-GTCS. Secondary Objective Detect the postictal prone position with an accuracy of 100%.

A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

This is a phase I study (Protocol: UX-GIP001-102) investigating UX-GIP001 Injection, a novel cell therapy product consisting of human GABAergic interneuron progenitor cells (GIP), for treating adult patients with drug-resistant unilateral medial temporal lobe epilepsy (MTLE). The primary objective is to assess the safety, tolerability, and preliminary efficacy of UX-GIP001. This is an open-label, single-arm study. All enrolled participants will receive the active investigational cell therapy. Seizure frequency and safety parameters will be evaluated by comparing post-transplant outcomes to pre-transplant baselines.

Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)

The goal of this clinical trial is to test if cognitive interventions in those with diagnosed epilepsy can help lessen cognitive lapses and improve overall brain health. Participants will participate in weekly, virtual group sessions led by a neuropsychologist for 12 weeks. After the 12-week mark, participants will be asked to practice what they learned for 9 more months. Participants will be asked to complete online questionnaires at certain times during the study. Researchers will compare this intervention group to another group that did not get the intervention to see if the intervention improves brain health. Participation in each of these groups will be randomly assigned. Participation in the study will last for one year.

Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1

This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.

Risk Factors for Drug-Resistant Epilepsy in Children

This prospective cohort study evaluates clinical, electroencephalographic predictors of drug-resistant epilepsy in children. Predictive statistical and machine-learning models will be developed to facilitate early identification of children at high risk for drug-resistant epilepsy.

AI-enhanced LF-MRI in Epilepsy

The global burden of epilepsy is high affecting over 50 million people worldwide. Majority live in low- and middleincome countries (LMICs) where access to diagnosis and treatment is limited. Accurate diagnosis of epilepsy and identification of the underlying cause through brain imaging is key to providing appropriate treatment. Magnetic resonance imaging (MRI) is the recommended modality of choice for brain imaging. However, in many LMICs it is scarce, and the cost of maintenance is unattainable. This study aims to explore the usefulness of a lower cost, more portable MRI machine for epilepsy diagnosis. It will be a proof-of-concept study evaluating the utility of low magnetic field MRI (LF-MRI) in epilepsy diagnosis. It will include 30 adults with epilepsy who have undergone a high field MRI (HF-MRI) brain scan as part of their routine clinical care under the University College London (UCL) Hospitals (UCLH), within twelve months of recruitment. Participants will be consecutively recruited and offered a LF-MRI brain scan on the Swoop MR Imaging System (Hyperfine) at the Birbeck-UCL Centre for Neuroimaging (BUCNI). Image post-processing will be performed using the open access machine learning program, LF-SynthSR, to enhance the image quality and allow for quantitative image analysis. Anonymised HF- and LF-MRI scans will be independently reported using a structured reporting template by two neuroradiologists. A perception survey will be administered to all participants to assess their tolerability of the LF-MRI. This study will serve as a foundation for future studies in this field and in areas where such innovations are most needed.

Lily's Grace Temporal Interference

This study is to evaluate the effectiveness of targeted Transcranial Electrical Stimulation with Temporal Interference (TES-TI) interventions to boost Non-Rapid Eye Movement (NREM) sleep, decrease seizures and promote emotional health in patients with epilepsy. Up to 24 participants (8 control participants for technical optimization prior to recruitment and 16 patients with epilepsy) will be enrolled and can expect to be on study for up to 24 months.

Real-World Evidence in Patient-Reported Outcomes for Medical Cannabis (MC-RWE)

This prospective observational study aims to describe the effectiveness of MC on pain, epilepsy, sleep and /or anxiety/depression in a cohorts of patients authorized to use MC, using pre-defined, validated self assessment scales.

Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures

This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.

Retinal OCT Changes and Biomarkers in Drug-Resistant Epilepsy

This prospective, longitudinal observational study investigates whether epilepsy involves a progressive neurodegenerative process. Retinal structural and microvascular changes assessed by optical coherence tomography (OCT) and optical coherence (OCTA) will be analyzed alongside inflammatory biomarkers (sCD14, sCD163, CCL2, IL-1β). The study aims to explore their association with epilepsy pathophysiology, clinical phenotype, prognosis, and drug-resistant epilepsy (DRE). Among participants with epilepsy, seizure severity and antiseizure medication-related adverse-effect burden will also be assessed longitudinally using the National Hospital Seizure Severity Scale (NHS3) and the Turkish version of Liverpool Adverse Events Profile (LAEP-TR).

Multimodal PET Imaging With 18F-FDG/SV2A/TSPO for Resection Planning in Drug-Resistant Epilepsy

This study focuses on the application value of 18F-FDG, SV2A, and TSPO PET imaging in the preoperative localization of epileptogenic foci in epilepsy. 18F-FDG PET detects glucose metabolism in brain tissue and is characterized by reduced metabolism during the interictal period. It is currently the most commonly used localization method in clinical practice, especially suitable for temporal lobe epilepsy, but has limited sensitivity to foci with insignificant metabolic changes. SV2A PET targets synaptic vesicle proteins and reflects synaptic density, showing reduced uptake in epileptogenic foci areas. It has high localization accuracy, can effectively supplement the diagnosis of 18F-FDG PET-negative cases, and also has good application prospects in non-temporal lobe epilepsy. TSPO PET monitors microglial activation to reflect neuroinflammation, with increased uptake in epileptogenic foci areas, and has unique auxiliary diagnostic value in refractory epilepsy and cases with concurrent brain injury. The combined application of the three can provide a more comprehensive imaging basis for preoperative localization of epilepsy, helping to optimize surgical plans.

Neural Mechanisms for Stopping Ongoing Speech Production (Study 2)

Speech and communication disorders often result in aberrant control of the timing of speech production, such as making improper stops at places where they should not be. During normal speech, the ability to stop when necessary is important for maintaining turn-taking in a smooth conversation. Existing studies have largely investigated neural circuits that support the preparation and generation of speech sounds. It is believed that activity in the prefrontal and premotor cortical areas facilitates high-level speech control and activity in the ventral part of the sensorimotor cortex controls the articulator (e.g. lip, jaw, tongue) movements. However, little is known about the neural mechanism controlling a sudden and voluntary stop of speech. Traditional view attributes this to a disengagement of motor signals while recent evidence suggested there may be an inhibitory control mechanism. This gap in knowledge limits our understanding of disorders like stuttering and aphasia, where deficits in speech timing control are among the common symptoms. The overall goal of this study is to determine how the brain controls the stopping of ongoing speech production to deepen our understanding of speech and communication in normal and impaired conditions.

Acute Recording of Stereotyped High-Frequency Oscillations

Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates \>=1kHz and deliver targeted electrical stimulation to achieve seizure control. In contrast to current closed-loop systems (RNS), which wait for the seizure to start before delivering stimulation, the BIC system will monitor the spatial topography and rate of stereotyped HFOs and deliver targeted stimulation to these HFO generating areas to prevent seizures from occurring. If the outcomes of our research in an acute setting become successful, the investigators will execute a clinical trial and run the developed methods with the implantable BIC system in a chronic ambulatory setting.

Neural Basis of Cognition

The overall purpose of this study is to better understand human cognition and human epilepsy by working with patients undergoing clinical treatment for pharmacologically resistant epilepsy. The investigators will investigate human cognition by conducting controlled experiments that focus on sensory, motor, and cognitive phenomena such as sensory processing, memory, and language. The investigators will also examine the neural underpinnings of epilepsy during both sleep and wakefulness to better understand both the foundations of epilepsy and how epilepsy affects cognition. The investigators hope to use these data to have a better understanding of cognition, epilepsy, and how the two interact. This will potentially lead to better markers for seizure onsets as well as epilepsy more generally. For this research, the investigators will use μECoG arrays manufactured by commercial partners. These arrays have passed all major ISO 10993 bio-compatibility tests. Based on this characterization and use in the intraoperative setting (limited duration and supervised usage), these devices pose a minimal risk to participants. Data will be analyzed and protected using the Duke SSRI protected research data network.

Surgery as a Treatment for Medically Intractable Epilepsy

Background: \- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experimental, but researchers are interested in using the data collected as part of routine standard epilepsy care to better understand epilepsy and its treatment. Objectives: \- To use surgery as a treatment for drug resistant epilepsy in children and adults. Eligibility: \- Children and adults at least 8 years of age who have simple or complex partial seizures (seizures that come from one area of the brain) that have not responded to medication, and who are willing to have brain surgery to treat their medically intractable epilepsy. Design: * Participants will be screened with a medical history, physical examination, and neurological examination. Imaging studies, including magnetic resonance imaging and computer-assisted tomography (CT), may also be conducted as part of the screening. Participants who do not need surgery or whose epilepsy cannot be treated surgically will follow up with a primary care physician or neurologist and will not need to return to the National Institutes of Health for this study. * Prior to the surgery, participants will have the following procedures to provide information on the correct surgical approach. * Video electroencephalography monitoring to measure brain activity during normal activities within a 24-hour period. Three to four 15-minute breaks are allowed within this period. * Electrodes placed directly in the brain or on the surface of the brain to measure brain activities and determine the part of the brain that is responsible for the seizures (seizure focus). * Participants will have a surgical procedure at the site of their seizure focus. Brain lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality will be either removed or treated in a way that will stop or help prevent the spread of seizures without affecting irreplaceable brain functions, such as the ability to speak, understand, move, feel, or see. * Participants will return for outpatient visits and brain imaging studies 2 months, 1 year, and 2 years after surgery.

Epilepsy Enhanced Care

Background: Epilepsy is a common brain condition that causes repeated seizures. People with epilepsy often need a lot of information to manage their health, but many do not receive enough education about their condition. Having good health literacy (the ability to find, understand, and use health information) is important for managing epilepsy well. Objective: This study aims to test whether a special educational program led by a trained epilepsy nurse, called "Epilepsy Enhanced Care," helps adults with epilepsy better understand and manage their health. Study design: This is a prospective, non-randomized, controlled study involving adults (aged 18 years or older) with epilepsy. Participants will be divided into three groups: * Intervention group: Patients with newly diagnosed epilepsy who will receive the "Epilepsy Enhanced Care" educational program in addition to their usual care. * Control group 1: Patients with newly diagnosed epilepsy who will receive only their usual care. * Control group 2: Patients who have had epilepsy for at least one year and will receive only their usual care. Intervention: The "Epilepsy Enhanced Care" program is a structured, one-on-one educational session delivered by a specialized epilepsy nurse within 2 months of diagnosis. The session covers topics such as epilepsy types, medications, safety planning, and lifestyle management. Patients and their caregivers may attend together. After the session, participants can contact the nurse by phone or email with further questions. Outcomes: The main outcome is the change in health literacy from the start of the study to 3 months after the intervention. Secondary outcomes include changes in epilepsy-specific knowledge, self-management skills, quality of life, anxiety, depression symptoms, and how often patients use healthcare services. Study duration: Participants in the intervention group and control group 1 will be followed for 12 months. Participants in control group 2 will be assessed at a single time point. The entire study is expected to take 24 months. Risks and benefits: The intervention involves only education and counseling, with no medications or medical devices. The risks are minimal, and participation is voluntary.

Diagnosing Epilepsy To EffeCT Change

The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational. Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends. All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.

Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up

The purpose of this research is to address the challenges of correctly monitoring, managing, and diagnosing epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research is being done to understand how the Minder System helps physicians make decisions about participant's epilepsy treatment after an actionable event. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational. Participants that have completed the DETECT study and received the Minder System previously will consent to join this long-term follow-up observational study. The study will collect information about general wellbeing, use of healthcare services, and experience using the Minder data over time to support long-term epilepsy care. All participants will continue to be followed by their treating physician and undergo assessments and visits every six (6) months until two (2) years after receiving the Minder device.

Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database

Objectives: The overall study objective is to compare the sensitivities and specificities of morphometric analysis techniques using structural MRI images based on pre- and postsurgical localization of epileptic foci in patients undergoing presurgical evaluation for medically refractory epilepsy. To carry out these analyses, we aim to establish an age-stratified normative imaging database using healthy volunteers. Additional objectives are to identify abnormal networks in these patients using resting state fMRI/EEG and MEG/EEG, and to use language and memory fMRI tasks to examine the effects of epileptogenic zones and surgery on cognitive function and the networks associated with these functions. Study population: 300 adults and children (age 8 and older) with uncontrolled focal epilepsy, and 200 age-stratified healthy volunteers. Design: A retrospective and prospective natural history study. Research procedures for patients in this study include neuropsychological testing and 1-4 MRI sessions during presurgical evaluation and an additional 1-3 MRI sessions and neuropsychological testing approximately 12 months post-operatively. Research testing (such as research neuropsychological tests or MRI scanning sequences) will be done during a visit for clinical testing whenever possible, likely reducing the number of required visits. Patients will also have optional MEG and 7T structural imaging. Data will also be obtained from patients who have already undergone epilepsy surgery if they had procedures as outlined in the protocol and are willing to share the data. Healthy volunteers will receive a subset of the pre-operative procedures for patients, requiring at least 3 visits. In order to ensure adequate data acquisition, subjects may be re-scanned up to three times for the portions of the study in which they participated, possibly requiring additional visits. Outcome measures: The main outcomes will be establishment of normative values for morphometric analysis methods in age-stratified normal controls, and comparison of the sensitivity and specificity of these measures to pre- and postsurgical localization of the epileptogenic zone. Secondary outcome measures will include determination of the sensitivity and specificity of source localization using MEG/EEG and resting state fMRI/EEG, and to evaluate changes in activation during rest, as well as language and memory fMRI tasks in patients pre- and postsurgically, to examine the effects of epileptogenic zones and surgery on cognitive function and the networks underlying these functions. ...

Mapping of Human Cognition

The purpose of this study is to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions "essential" for these processes, to compare the loci of "crucial" language, visual, motor and cognitive sites as determined by CSM with the loci determined by a battery of tasks using fMRI for each individual and to use these data in patients undergoing intracranial electro-corticographyto determine the loci of essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses of these intracranial recordings to study information flow between these areas.

Risk Prevention Program and Therapeutic Patient Education Program of Patients With Uncontrolled Epilepsy

Pilot, controled, randomized study aiming to evaluate a plan for the prevention of risks related to epilepsy, 3 months after the last therapeutic patient education session. Two groups of patients will be compared: group "intervention" (consultation with the neurologist then a psychologist followed by a session dedicated to risk prevention ("Recognize and Manage risks") integrated into usual Therapeutic Patient Education (TPE) versus "control" group (usual consultations with the neurologist and usual TPE). 37 subjects per group will be included in this study.

Training Program to Improve EEG Competence

The goal of this clinical trial is to investigate the extent to which a practice-oriented training program for intensive care nursing staff and non-physician treatment teams can contribute to the earlier detection of epileptic seizures, with particular emphasis on SE. Further objectives include enhancing competence in EEG interpretation and minimizing existing communication and procedural barriers within the interdisciplinary treatment team. Participants will participate in a half-day training session, which will include: * attending a specialist lecture, * completing two knowledge assessments and one evaluation questionnaire, * completing an additional brief evaluation questionnaire after one month, and * completing a further brief evaluation questionnaire after three months to assess the sustainability of the learning outcomes.

Hippocampal Oscillations During Exploration

The objective of this study is to determine how visuomotor exploration relates to hippocampal activity along its long axis. The study will investigate the neurophysiological mechanisms in the hippocampus during (1) visual exploration in surgical patients using high-resolution iEEG, and (2) ambulatory exploration in patients implanted with RNS devices.