Diagnosing Epilepsy To EffeCT Change

Official title

A Prospective Study to Evaluate the Use of the Minder Device to Aid in Developing a Treatment Plan After Inconclusive Prolonged EEG in Patients With Epilepsy

Overview

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.

Interventions

• Device Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system)
  The Minder System consists of an implanted device containing an electrode lead and telemetry unit. The electrode lead contains four electrodes that are placed under the patient's scalp to record electrical activity (EEGs) from both sides of the brain. The electrode lead is connected to the telemetry unit that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.

Primary outcome measures

• Compare the proportion of participants receiving the Minder System with those receiving Standard of Care (SOC) as a means of obtaining an actionable event based on clinical data (i.e. Minder EEG data, non-Minder EEG data, SOC assessments, etc.). [Time frame: 6 months]

Secondary outcome measures (6)

• Compare the time to the first actionable event. [Time frame: 6 months]
• Compare participant wellbeing between groups with the Beck Depression Inventory (BDI) for symptoms associated with depression. [Time frame: 6 months]
• Compare participant wellbeing between groups with the Beck Anxiety Inventory (BAI) for symptoms associated with anxiety. [Time frame: 6 months]
• Compare healthcare utilization between groups by the number of hospital visits. [Time frame: 6 months]
• Compare healthcare utilization between groups by medication usage. [Time frame: 6 months]
• Compare healthcare utilization between groups by the number of surgeries or procedures. [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

• Diagnosis of focal and/or generalized epilepsy.
• Drug-resistant
• At least an average of 1 seizure within the past 3 months
• Participant completed a multi-day EEG assessment that was inconclusive, and is unchanged since the last EEG monitoring.

Exclusion criteria

• Epilepsy surgery within the past 6 months
• Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS)
• Participant needs treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithrotripsy, and diathermy
• Participant cannot have surgery to have the device implanted

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Double blind

Primary purpose

Diagnostic

Study locations

United States · 19 centers

• Mayo Clinic - Arizona — Phoenix
• University of California, Irvine Medical Center — Irvine
• Stanford — Palo Alto
• Yale School of Medicine — New Haven
• Mayo Clinic - Florida — Jacksonville
• Nicklaus Children's Hospital — Miami
• USF Health — Tampa
• IU Health Neuroscience Center — Indianapolis
• … and 11 more centers

Publications

• Halliday AJ, Gillinder L, Lai A, Seneviratne U, Fontenot H, Cameron T, McLean K, Niemiec A, Raghupathi R, Ganguly TM, Ellis C, Conrad EC, Briggs R, Bulluss K, Kwan P, Perucca P, O'Brien TJ, McGonigal A, Gutman M, Papacostas J, Fong MWK, Lee A, Crompton DE, Laing J, Wijayath M, Morokoff AP, Murphy M, D'Souza WJ, Cook MJ. The UMPIRE study: A first-in-human multicenter trial of bilateral subscalp mon PMID 40445205

Identifiers

NCT: NCT07110337 · EM2401

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗