Clinical Research Directory

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.

OPM MEG in Pre-surgical Mapping for Patients With Epilepsy

Magnetoencephalography, or "MEG", is a brain-scanning method which has been available for many years. It is used in the UK and worldwide to help patients with epilepsy, who need surgery to resolve their seizures. The MEG scan can help inform the surgeon about where to operate, by mapping the abnormal brain activity caused by epilepsy. During a traditional MEG recording, patients sit very still with their head in a rigid helmet which houses many tiny sensors. This can be uncomfortable, and there are additional problems if the patient is a child, because the helmet is often too big. It is not possible to record useful data from the very youngest children with a traditional MEG scanner. But there is a new generation of MEG systems, called OPM-MEG, which employ lightweight sensors housed in a kind of hat. The hat can be appropriately sized for children, and the patient can move comfortably. The new systems are also more cost-effective to run. It is important to know whether the accepted clinical protocols for using MEG in planning epilepsy surgery can be directly transferred to OPM-MEG. It is also important to understand how the patient experience compares across systems. In this project, 20 volunteer patients will be recruited from among those children already having routine pre-surgical MEG recordings Aston University. They will be invited to participate in an OPM-MEG recording in the same facility at Aston University, so that data from the new OPM-MEG device can be compared with the data from the old MEG scanner. Data analysis pipelines will be streamlined, and the accuracy of the results compared to determine whether the improved sensor arrangement for children in the OPM-MEG system leads to better localisation of epileptiform activity.

Low-Intensity Focused Ultrasound Neuromodulation for Epilepsy

This study is an invite only study looking at the effects of Low-Intensity Focused Ultrasound (LIFU) on epilepsy patients with implanted electrodes under the care of Dr. Shah.

CEST-based Biomarkers to Delineate the Epileptogenic Zone

Epilepsy is a common neurological disorder with an incidence of 1%. Although many anti-seizure medications are available, about 30% of patients are resistant to drug treatments. Epilepsy surgery is an effective treatment for some of these patients. It involves removing the brain region responsible for generating seizures, called the epileptogenic zone (EZ). A pre-surgical evaluation is performed to locate and delineate the region where seizures originate (the seizure onset zone \[SOZ\]) and to confirm that this zone is unique and accessible for surgery-that is, that the potential benefits outweigh the risks of functional deficits resulting from its removal. The lesion itself is identified and characterized through post-operative histological examination and, in some cases, based on MRI criteria. During pre-surgical evaluation, in cases where no lesion is visible on MRI or when surface EEG suggests that a large or multiple epileptic networks may be involved, stereo-electroencephalography (SEEG) is the method of choice to delineate the area for resection. However, SEEG has limitations: it is invasive and records from a restricted brain volume. Despite advances in neuroimaging techniques, the localization of the epileptogenic zone and mapping of functional brain alterations still need improvement beyond what morphological MRI anomalies can reveal. Because epileptic tissue is characterized by increased neuronal excitability and metabolic abnormalities, techniques that allow precise evaluation of these changes could deepen our understanding of the disease and provide new tools for epilepsy surgery. An alternative MRI approach based on metabolite quantification using chemical exchange saturation transfer (CEST) has been suggested to aid in localizing the epileptogenic zone in preliminary studies. However, limited availability of ultra-high-field MRI, low localization precision of the epileptogenic zone, and lack of systematic validation in patients have delayed its clinical use. This study aims to explore a cohort of patients with temporal lobe epilepsy who are candidates for surgery using CEST MRI. We will quantify glutamate and glucose concentrations using glu-CEST and gluco-CEST, respectively, and correlate the results with the localization of the epileptogenic zone determined by pre-surgical evaluation, and where applicable, SEEG and post-operative outcomes.

A Study to Evaluate the Safety and Effectiveness of Magnetic Resonance-Guided Ultrasound Ablation of the Anterior Nucleus of Thalamus for the Treatment of Drug-resistant Epilepsy.

The study "Safety and Efficacy Evaluation of MR-Guided Focused Ultrasound Anterior Thalamic Nucleus Ablation for Drug-Resistant Epilepsy" from Chinese PLA General Hospital, is a single-center, prospective, single-arm study. It uses a MR-guided Focused Ultrasound Therapy System and plans to recruit 20 patients with drug-resistant epilepsy who are ≥20 years old, have a WAIS score ≥70, an average of ≥3 monthly epileptic seizures in the 3 months before enrollment, and are refractory to at least 2 antiepileptic drugs (including 1 first-line drug), excluding those with unstable cardiac function, brain tumors, previous brain surgery history, etc. Anterior thalamic nucleus ablation is performed via MRgFUS, with multiple follow-ups from 48 hours to 2 years postoperatively. Safety is evaluated by the incidence of adverse events within 2 years, efficacy by seizure frequency recorded in epilepsy diaries and the QOLIE-31 scale. Statistical analysis is conducted using toolkits, while risks such as MRI-induced claustrophobia and CT radiation are controlled. It adheres to GCP and the Declaration of Helsinki to ensure data authenticity and subjects' rights. The technology provider is responsible for the normal operation of the device and providing 20 sets of treatment consumables.

Trigeminal Nerve Stimulation of the Treatment of Epilepsy

Background: Epilepsy is a common neurological disorder among veterans. Medications do not control seizures in 1/3rd of patients, who often require neurostimulation. However, current neurostimulation devices are invasive. Objective: The investigators propose a novel clinical trial to repurpose the FDA-approved Cefaly device, designed for migraine relief, to treat epilepsy. The Cefaly device works by non-invasive Trigeminal neurostimulation (TNS). TNS has previously shown promising preliminary results in seizure improvement. Design: The investigators will engage 24 veterans with drug-resistant epilepsy, half of whom will receive standard care, while the other half will receive standard care plus Cefaly. This will be followed by a crossover of the treatment/control groups. The primary objective is to evaluate seizure frequency improvement over 12 months.

Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)

The occurrence of seizures in epilepsy is not entirely random. Temporal patterns that organize the occurrence of seizures over weeks and months were previously unraveled using intracranial EEG System (IEEG) that monitors epileptic brain activity chronically. Seizures typically recur with patient-specific periodicity and are preceded by increases of epileptic brain activity over days. Here, the investigators developed new methods to forecast seizure likelihoods at a 24-h horizon. In this trial, participants will be provided with daily estimates about their upcoming risk of seizures. As a primary outcome, the performance of forecasts will be evaluated against the occurrence of electrographic seizures. As secondary outcome, the forecast's potential benefit for users in conveying actionable information in real-life will be assessed.