Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)

November 20, 2023 updated by: King's College London

Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Epilepsy
33 participants with drug-resistant epilepsy will be implanted with the EEGTM SubQ device under local anaesthesia, and will collect 2-channel EEG data, as well as completing an electronic seizure diary, for 6 months
Device: EEG SubQ subcutaneous EEG device
2-channel subcutaneous EEG device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution
Time Frame: 6 months
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
6 months
Diagnostic accuracy of 24/7 EEG SubQ solution compared to diary
Time Frame: 6 months
Within-participant correlation between seizure counts per month from participant-reported seizure diary and 'ground truth' EEG seizure occurrences per month
6 months
Clinician rating of accuracy of 24/7 EEG SubQ
Time Frame: 6 months
Clinician rating of accuracy of 24/7 EEG SubQ solution
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical relevance of the 24/7 EEG SubQ solution
Time Frame: baseline, 2 months and 6 months
Change over time for average Health Care Professional (HCP) questionnaires 'Communication', 'Insight' & 'Potential of 24/7 EEG™' scores
baseline, 2 months and 6 months
Proportion of treating clinicians changing clinical management
Time Frame: months 1, 2, 3, 4, 5, 6
Proportion of treating clinicians changing clinical management throughout the study due to information from the 24/7 EEG SubQ Solution
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
Time Frame: 6 months
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
6 months
participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution
Time Frame: baseline, 2 months and 6 months
Post-market surveillance questionnaire
baseline, 2 months and 6 months
Participant adherence with 24/7 EEG™ SubQ Solution
Time Frame: 6 months
Wear time
6 months
Device deficiency
Time Frame: 6 months
Number of Device deficiencies
6 months
EQ-5D-5L score
Time Frame: baseline, 2 months and 6 months
Change over time for average EQ-5D-5L scores at baseline, 2- months and 6 months
baseline, 2 months and 6 months
Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score
Time Frame: baseline, 2 months and 6 months
Change over time for average Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) scores at baseline, 2-months and 6 months
baseline, 2 months and 6 months
Impact of epilepsy score
Time Frame: baseline, 2 months and 6 months
Change over time for average Impact of epilepsy score at baseline, 2-months and 6 months
baseline, 2 months and 6 months
Perceived Self-Mastery Over Epilepsy score
Time Frame: baseline, 2 months and 6 months
Change over time for average Perceived Self-Mastery Over Epilepsy score at baseline, 2-months and 6 months
baseline, 2 months and 6 months
health economic impact of epilepsy for participants that have used the 24/7 EEG™ SubQ Solution
Time Frame: 6 months
Client Services Receipt Inventory (CSRI) scores at 6 months
6 months
health economic impact of epilepsy for participants compared to historical controls
Time Frame: 6 months
Client Services Receipt Inventory (CSRI) score at 6 months compared with the 138 participants in SMILE study in the treatment-as-usual arm
6 months
Cost-effectiveness of current practice and 24/7 EEG™ SubQ Solution
Time Frame: 6 months
Quality-adjusted life-years (QALYs) score
6 months
EQ-5D-5L score comparison with historical controls
Time Frame: 6 months
EQ-5D-5L score compared with the 138 participants in SMILE study in the treatment-as-usual arm
6 months
Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score comparison with historical controls
Time Frame: 6 months
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
6 months
Impact of epilepsy score comparison with historical controls
Time Frame: 6 months
Impact of epilepsy score compared with the 138 participants in SMILE study in the treatment-as-usual arm
6 months
Perceived Self-Mastery Over Epilepsy score comparison with historical controls
Time Frame: 6 months
Perceived Self-Mastery Over Epilepsy score compared with the 138 participants in SMILE study in the treatment-as-usual arm
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College Hospital NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark P Richardson, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRAS: 324630

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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