Key takeaways:
- No severe device- or implant-related hostile occasions had been reported.
- A excessive diploma of seizures and associated neurophysical indicators had been captured by subscalp recordings.
A subscalp electroencephalographic gadget providing steady monitoring was secure and efficacious in recording seizure exercise for sufferers with epilepsy, knowledge printed in Epilepsia present.
“Sufferers with epilepsy are handled with anti-seizure medicines to scale back seizures and related dangers,” Amy J. Halliday, MD, a neurologist at St. Vincent’s Hospital, in Melbourne, Australia, informed Healio.
“Therapy success is at present assessed by affected person self-report of seizures, which is more and more being proven to be extremely inaccurate in most sufferers,” she mentioned.
Latest knowledge has indicated that sufferers are liable to under-reporting and over-reporting seizures of their diaries, Halliday added.
“One giant research of roughly 3,500 ambulatory EEG research discovered that 80% of patient-reported occasions weren’t seizures and two-thirds of seizures had been unreported,” Rohan Hoare, PhD, CEO of Epiminder, informed Healio.
Hoare famous one other research that discovered that caregivers are inaccurate in recognizing seizures as properly.
“Counting on others to evaluate seizure burden stays a problem,” he mentioned.
Contemplating these patterns, Halliday mentioned the shortage of change within the proportion of sufferers with epilepsy on medicines who’re seizure-free throughout a number of a long time isn’t a surprise, though many new medicines have been launched. On account of this unreliability, Halliday and colleagues sought to look at the protection and efficacy of Minder (Epiminder), an implantable bilateral subscalp electroencephalographic monitoring system.
“Lengthy-term sub-scalp EEG acquisition utilizing the Minder system is the primary know-how accessible within the U.S. to evaluate seizure burden precisely and objectively, representing a paradigm shift within the administration of epilepsy,” Hoare mentioned.
“Lengthy-term EEG monitoring additionally permits prognosis of occasions of unclear etiology, particularly necessary for the 30% of epilepsy sufferers that additionally undergo psychogenic non-epileptic seizures,” Halliday added.
Additional, Hoare mentioned that neurologists want goal strategies for detecting seizures to allow them to precisely assess the efficacy of medicine and decide whether or not they need to take into account surgical interventions. “Bettering these reporting inaccuracies utilizing the Minder system has the potential to remodel outcomes in sufferers with epilepsy,” Hoare mentioned.
The potential, multicenter, first in-human medical trial, sUb-scalp Monitoring ePileptic seIzuREs (UMPIRE), enrolled 31 adults with focal or generalized epilepsy and at the very least two recorded seizures per 30 days at 5 areas throughout Australia between November 2019 and July 2023.
The implant was positioned within the subgaleal area with the leads positioned behind every affected person’s ear with one recording contact positioned over every hemisphere of the mind. Alerts had been transmitted through radio to an exterior, wearable Bluetooth gadget that transmitted EEG knowledge to a smartphone app that saved the info forward of importing to cloud-based storage.
The gadget was activated inside 14 days of implantation., As soon as energetic, members saved an in depth seizure diary that pinpointed seizure location whereas additionally logging a variety of demographic data. Sufferers had been tracked at 4, 6, 12 and 24 weeks post-implantation after which noticed for as much as 6 months.
The research’s main final result was hostile occasions throughout the 6-month commentary interval. Secondary outcomes primarily involved whether or not regular neurophysiological indicators, interictal discharges (IEDs) and seizures noticed on the gadget through 1-week recordings made on the 4- and 24-week intervals had been identifiable on subscalp recordings. Different outcomes included comparability of subscalp knowledge with diary reviews.
After 5 people withdrew from the research, 26 (imply age at enrollment = 45 years; 50% feminine) acquired implants.
In keeping with outcomes, 87 hostile occasions had been reported amongst 20 people examined inside the first 6 months. Nevertheless, none of those had been severe device- or implant procedure-related hostile occasions.
Eight members skilled 13 device-related hostile occasions, with eight immediately associated to the gadget and 5 associated to the research process. Eleven with 11 of those had been deemed delicate and two had been thought-about reasonable.
The commonest hostile occasions had been scalp ache and/or complications, with 5 sufferers experiencing eight occasions… Additionally, eight of the 13 device-related hostile occasions had resolved earlier than the research interval was over.
The researchers logged 23 hostile occasions associated to the process amongst 12 sufferers as properly, with 5 associated on to the process, 17 labeled as delicate, and 6 thought-about reasonable. Six sufferers skilled 11 severe hostile occasions, however none of them had been associated to the gadget or process.
Amongst 44 video-monitored occasions from 24 enrollees at 4 and 24 weeks, the gadget was ready to log incidence at a excessive fee of constancy. Sleep spindles had been famous on 23 of 23 and on 20 of 21 scalp recordings, and IEDs had been famous on 17 of 23 and 17 of 21. All chewing artifacts had been current as properly.
Moreover, all sleep spindles, chewing artifacts, IEDs and electrographic seizures noticed on scalp recordings, together with eight sufferers with 25 seizures, had been recognized on subscalp recordings. In contrast with two-channel scalp recordings, the researchers mentioned that subscalp recordings had increased readability.
Concerning comparisons between subscalp knowledge and diary entries, Halliday and colleagues reported 600 seizures amongst 23 people with dependable EEG knowledge accessible for 63% (377 of 600) of all diary notation. Corresponding seizures had been recorded for 31% of those occasions (115 of 377).
“Minder’s bilateral protection of the mind additionally permits seizure lateralization, which may inform surgical eligibility and doubtlessly open the door to healing epilepsy surgical procedure for some sufferers,” Halliday informed Healio.
Hoare added: “By offering an goal measure of mind exercise, the Minder system gives goal knowledge concerning remedy efficacy, which in fact is beneficial in medical follow and will doubtlessly help in figuring out eligibility and outcomes in medical trials.”
References:
Hannon T, et al. Epilepsia. 2024;doi:10.1111/epi.17930.
Moraes J, et al. Epilepsia. 2025;doi:10.1111/epi.18499.
For extra data:
Amy J. Halliday, MD, may be reached at neurology@healio.com.
Rohan Hoare, PhD, may be reached at rhoare@epiminder.com.
