Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies

NCT06855901 | Recruiting

• 3 other identifiers: PNRR-MR1-2022-1237649133/2023/DISP/AOUMO127/2023/DISP/AOUMO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

With this study the Investigator expects to develop a precise patient-centered model of care by means of home ultra-long-term EEG monitoring with a minimally invasive wearable EEG device (sqEEG). The following aims will be pursued:

1. 1.to assess the sensitivity, reliability, and safety of sqEEG to record seizures over prolonged periods;
2. 2.to verify sensitivity and reliability of automated seizure detection algorithms and to assess circadian and ultradian seizure/interictal epileptic discharges; distribution for the development of personalized seizure action plan;
3. 3.to evaluate whether data collected with sqEEG can improve the clinical management of the patients and treatment outcomes.

Conditions

Epilepsies; Epilepsies, Focal; Epileptic Encephalopathy

Keywords

Epilepsy; Epileptic encephalopathies; subscalp EEG; Ultra-long EEG monitoring

Outcome Measures

Primary Outcomes (1)

• Assessment of the reportability

  The results (i.e., number of seizures, date and time) will be matched with the subject's seizure diary to look for concordance.

  12-24 weeks from device activation

Secondary Outcomes (3)

• Assessment of Device-Related Adverse Events:

  12-24 weeks from device activation

• Evaluation of the algorithm for automatic seizure detection (ASD)

  12-24 weeks from device activation

• Assessment of potential clinical impact

  12 to 24 weeks from device activation

Study Arms (1)

Experimental Group

EXPERIMENTAL

Patients with drug-resistant epilepsies. Age \> 12 years

Device: Ultra-longterm EEG monitoring at home by means of a scubscalp electrode implant.

Interventions

Ultra-longterm EEG monitoring at home by means of a scubscalp electrode implant. DEVICE

Subjects with uncontrolled seizures previously investigated in outpatients epilepsy clinics and for whom an admission to the Epilepsy Monitoring Unit is indicated by clinical practice, will be screened for eligibility. Implantation of subcutaneous EEG electrodes will be done at each Research Unit by a neurosurgeon/surgeon. The implantation procedure will consist of placing subcutaneously the electrode contacts over the site of the suspected seizure focus as defined by a previous Video-EEG and neuroimaging evaluations. Surgical procedures will be performed under local anesthesia. If the device is well-tolerated, all the subjects will proceed to the extended home monitoring study, which is the core of the study protocol. The aim of the extended study is to assess sensitivity of seizure detection of sqEEG in comparison to subject's home diary, and the tolerability and safety of sqEEG in a period of 6 months.

Also known as: EEG SubQ subcutaneous EEG device

Experimental Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 12 years old, with or without intellectual disabilities;
• Diagnosis of drug resistant seizures, DEE or rare epilepsies ;
• One or more seizure types as established by previous epilepsy history thus allowing to define seizure type and scalp topography of the ictal discharge;
• Availability for the duration of the study (3 months);

You may not qualify if:

• Subjects with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder;
• Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement;
• Subject has an infection at implant site;
• Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease;
• Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant (cochlear implant(s));
• Subject has a profession or hobby that includes activity imposing an unacceptable risk for trauma to the device or implant site, e.g. martial arts or boxing;
• Subject has a contraindication to the use of local anesthetic drugs used during implantation- and removal of the device;
• Subject is unable or does not have the necessary assistance to properly operate the device system.
• Pregnancy

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead
• Azienda Ospedaliera Universitaria Federico II (AOU Federico II): collaborator
• Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy: collaborator
• Ospedale Pediatrico Bambino Gesù, Rome (IT): collaborator

Study Sites (4)

Ospedale pediatrico Bambino Gesù

Roma, Italy, 00165, Italy

NOT YET RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, Italy, 34128, Italy

NOT YET RECRUITING

S.S.D. Neurofisiologia Clinica - AOU di Modena

Modena, Taly, 41126, Italy

RECRUITING

Azienda Ospedaliero Universitaria Federico II - Napoli

Napoli, Taly, 80131, Italy

NOT YET RECRUITING

Related Publications (13)

• Weisdorf S, Gangstad SW, Duun-Henriksen J, Mosholt KSS, Kjaer TW. High similarity between EEG from subcutaneous and proximate scalp electrodes in patients with temporal lobe epilepsy. J Neurophysiol. 2018 Sep 1;120(3):1451-1460. doi: 10.1152/jn.00320.2018. Epub 2018 Jul 11.

  PMID: 29995605 BACKGROUND

• Viana PF, Remvig LS, Duun-Henriksen J, Glasstetter M, Dumpelmann M, Nurse ES, Martins IP, Schulze-Bonhage A, Freestone DR, Brinkmann BH, Kjaer TW, Richardson MP. Signal quality and power spectrum analysis of remote ultra long-term subcutaneous EEG. Epilepsia. 2021 Aug;62(8):1820-1828. doi: 10.1111/epi.16969. Epub 2021 Jul 12.

  PMID: 34250608 BACKGROUND

• Viana PF, Duun-Henriksen J, Glassteter M, Dumpelmann M, Nurse ES, Martins IP, Dumanis SB, Schulze-Bonhage A, Freestone DR, Brinkmann BH, Richardson MP. 230 days of ultra long-term subcutaneous EEG: seizure cycle analysis and comparison to patient diary. Ann Clin Transl Neurol. 2021 Jan;8(1):288-293. doi: 10.1002/acn3.51261. Epub 2020 Dec 4.

  PMID: 33275838 BACKGROUND

• Trivisano M, Specchio N. What are the epileptic encephalopathies? Curr Opin Neurol. 2020 Apr;33(2):179-184. doi: 10.1097/WCO.0000000000000793.

  PMID: 32049741 BACKGROUND

• Specchio N, Wirrell EC, Scheffer IE, Nabbout R, Riney K, Samia P, Guerreiro M, Gwer S, Zuberi SM, Wilmshurst JM, Yozawitz E, Pressler R, Hirsch E, Wiebe S, Cross HJ, Perucca E, Moshe SL, Tinuper P, Auvin S. International League Against Epilepsy classification and definition of epilepsy syndromes with onset in childhood: Position paper by the ILAE Task Force on Nosology and Definitions. Epilepsia. 2022 Jun;63(6):1398-1442. doi: 10.1111/epi.17241. Epub 2022 May 3.

  PMID: 35503717 BACKGROUND

• Remvig LS, Duun-Henriksen J, Furbass F, Hartmann M, Viana PF, Kappel Overby AM, Weisdorf S, Richardson MP, Beniczky S, Kjaer TW. Detecting temporal lobe seizures in ultra long-term subcutaneous EEG using algorithm-based data reduction. Clin Neurophysiol. 2022 Oct;142:86-93. doi: 10.1016/j.clinph.2022.07.504. Epub 2022 Aug 8.

  PMID: 35987094 BACKGROUND

• Pathmanathan J, Kjaer TW, Cole AJ, Delanty N, Surges R, Duun-Henriksen J. Expert Perspective: Who May Benefit Most From the New Ultra Long-Term Subcutaneous EEG Monitoring? Front Neurol. 2022 Jan 20;12:817733. doi: 10.3389/fneur.2021.817733. eCollection 2021.

  PMID: 35126304 BACKGROUND

• Kjaer TW, Remvig LS, Helge AW, Duun-Henriksen J. The Individual Ictal Fingerprint: Combining Movement Measures With Ultra Long-Term Subcutaneous EEG in People With Epilepsy. Front Neurol. 2021 Dec 23;12:718329. doi: 10.3389/fneur.2021.718329. eCollection 2021.

  PMID: 35002910 BACKGROUND

• Muller AR, Brands MMMG, van de Ven PM, Roes KCB, Cornel MC, van Karnebeek CDM, Wijburg FA, Daams JG, Boot E, van Eeghen AM. Systematic Review of N-of-1 Studies in Rare Genetic Neurodevelopmental Disorders: The Power of 1. Neurology. 2021 Mar 16;96(11):529-540. doi: 10.1212/WNL.0000000000011597. Epub 2021 Jan 27.

  PMID: 33504638 BACKGROUND

• Elger CE, Hoppe C. Diagnostic challenges in epilepsy: seizure under-reporting and seizure detection. Lancet Neurol. 2018 Mar;17(3):279-288. doi: 10.1016/S1474-4422(18)30038-3.

  PMID: 29452687 BACKGROUND

• Cook MJ, O'Brien TJ, Berkovic SF, Murphy M, Morokoff A, Fabinyi G, D'Souza W, Yerra R, Archer J, Litewka L, Hosking S, Lightfoot P, Ruedebusch V, Sheffield WD, Snyder D, Leyde K, Himes D. Prediction of seizure likelihood with a long-term, implanted seizure advisory system in patients with drug-resistant epilepsy: a first-in-man study. Lancet Neurol. 2013 Jun;12(6):563-71. doi: 10.1016/S1474-4422(13)70075-9. Epub 2013 May 2.

  PMID: 23642342 BACKGROUND

• Blachut B, Hoppe C, Surges R, Elger C, Helmstaedter C. Subjective seizure counts by epilepsy clinical drug trial participants are not reliable. Epilepsy Behav. 2017 Feb;67:122-127. doi: 10.1016/j.yebeh.2016.10.036. Epub 2017 Jan 28.

  PMID: 28139449 BACKGROUND

• Blachut B, Hoppe C, Surges R, Stahl J, Elger CE, Helmstaedter C. Counting seizures: The primary outcome measure in epileptology from the patients' perspective. Seizure. 2015 Jul;29:97-103. doi: 10.1016/j.seizure.2015.03.004. Epub 2015 Apr 13.

  PMID: 26076850 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stefano Meletti, MD, PhD

  Azienda Ospedaliero Universitaria di Modena - Ospedale Civile di Baggiovara - S.S.D. Neurofisiologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Maffei, PhD

CONTACT

+390593961157; maffei.stefania@aou.mo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: March 4, 2025
• Study Start: January 17, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

IT (4)