Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG

King's College London33 enrolled

Overview

The study will investigate whether a novel method to accurately count epileptic seizures, using a CE-marked minimally-invasive ultra long-term subcutaneous electroencephalography (EEG) solution (UNEEG™ SubQ , including 24/7 EEG SubQ), (i) is more accurate than a participant-reported seizure diary; (ii) is feasible and acceptable to participants and clinicians; (iii) reduces impacts of epilepsy and improves quality-of-life; and (iv) provides gains to the healthcare system when rolled-out into the National Health Service (NHS). 33 participants with drug-resistant epilepsy will be implanted with the UNEEG™ SubQ device and will collect data for six months. Annotated seizures from the EEG data will be sent weekly to the treating clinicians, who will communicate with the participants on a monthly basis, and will be free to make any management changes.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Have given written informed consent * Diagnosis of treatment-resistant epilepsy of any syndrome in which seizures are detectable in scalp EEG with two electrodes. * Adults (≥18 years of age) * Participant routinely keeps a seizure diary, has a smartphone and is willing to use the electronic diary for the study. * Experiencing ≥10 seizures per year according to their existing seizure diary. * Willing and able to comply with study procedures Key Exclusion Criteria: * Established current diagnosis of psychogenic non-epileptic attacks (dissociative seizures) * Frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleep walking, night terrors)

Outcomes

Primary Outcomes

Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution

Within-participant correlation between seizure counts per month estimated from rapid review of annotated 24/7 EEG™ SubQ data and 'ground truth' EEG seizure occurrences per month

Time frame: 6 months

Diagnostic accuracy of 24/7 EEG SubQ solution compared to diary

Within-participant correlation between seizure counts per month from participant-reported seizure diary and 'ground truth' EEG seizure occurrences per month

Time frame: 6 months

Clinician rating of accuracy of 24/7 EEG SubQ

Clinician rating of accuracy of 24/7 EEG SubQ solution

Time frame: 6 months

Secondary Outcomes

Clinical relevance of the 24/7 EEG SubQ solution

Change over time for average Health Care Professional (HCP) questionnaires 'Communication', 'Insight' \& 'Potential of 24/7 EEG™' scores

Time frame: baseline, 2 months and 6 months

Proportion of treating clinicians changing clinical management

Proportion of treating clinicians changing clinical management throughout the study due to information from the 24/7 EEG SubQ Solution

Time frame: months 1, 2, 3, 4, 5, 6

Participants' perception of the value of receiving feedback about seizure occurrences estimated from EEG data recorded with 24/7 EEG™ SubQ

Participants overall rating of the value of receiving feedback about seizures occurrences every month, across the full study period, from the EEG data recorded with 24/7 EEG™ SubQ

Time frame: 6 months

participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution

Post-market surveillance questionnaire

Time frame: baseline, 2 months and 6 months

Participant adherence with 24/7 EEG™ SubQ Solution

Wear time

Time frame: 6 months

Device deficiency

Number of Device deficiencies

Time frame: 6 months

EQ-5D-5L score

Change over time for average EQ-5D-5L scores at baseline, 2- months and 6 months

Time frame: baseline, 2 months and 6 months

Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score

Change over time for average Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) scores at baseline, 2-months and 6 months

Time frame: baseline, 2 months and 6 months

Impact of epilepsy score

Change over time for average Impact of epilepsy score at baseline, 2-months and 6 months

Time frame: baseline, 2 months and 6 months

Perceived Self-Mastery Over Epilepsy score

Change over time for average Perceived Self-Mastery Over Epilepsy score at baseline, 2-months and 6 months

Time frame: baseline, 2 months and 6 months

health economic impact of epilepsy for participants that have used the 24/7 EEG™ SubQ Solution

Client Services Receipt Inventory (CSRI) scores at 6 months

Time frame: 6 months

health economic impact of epilepsy for participants compared to historical controls

Client Services Receipt Inventory (CSRI) score at 6 months compared with the 138 participants in SMILE study in the treatment-as-usual arm

Time frame: 6 months

Cost-effectiveness of current practice and 24/7 EEG™ SubQ Solution

Quality-adjusted life-years (QALYs) score

Time frame: 6 months

EQ-5D-5L score comparison with historical controls

EQ-5D-5L score compared with the 138 participants in SMILE study in the treatment-as-usual arm

Time frame: 6 months

Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score comparison with historical controls

Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score compared with the 138 participants in SMILE study in the treatment-as-usual arm

Time frame: 6 months

Impact of epilepsy score comparison with historical controls

Impact of epilepsy score compared with the 138 participants in SMILE study in the treatment-as-usual arm

Time frame: 6 months

Perceived Self-Mastery Over Epilepsy score comparison with historical controls

Perceived Self-Mastery Over Epilepsy score compared with the 138 participants in SMILE study in the treatment-as-usual arm

Time frame: 6 months

Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts