Epilepsy and intellectual disability Nervous System Diseases
Conditions
Interventions
Study procedure and data collection:
For individual participants, the study will last for approximately 7 months, with a 6-month period of having the SubQ device implanted and actively capturing EEG d
if the patient is determined to have the capacity to provide consent, and they do so, they will be provided with a dummy device to trial. This is the same external component as the real device but doe
Sponsors
University of Plymouth
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PwID: 1. Adults over 18 years old 2. Clinical diagnosis of epilepsy, considered pharmacoresistant 3. Clinical diagnosis of mild to moderate ID based on DSM/ICD classification 4. Patient has the capacity to consent and consents to participate 5. Able to tolerate the dummy device (device worn for at least 40% of a 1-2 week test period) Family member/carer: 1. Family member/carer is willing to keep a routine seizure diary for the course of the study 2. Retrospective seizure diary data available for the proceeding last 6 months 3. According to a family member, carer, or clinical record, the participant is having at least monthly ‘episodes of interest’ (it may be unclear whether these are epileptic or behavioural episodes) 4. Agree to participate in the study, support study activities and comply with these Healthcare professional: 1. PwID recommended by their epileptologist for long-term EEG monitoring Agree to participate in the study, support study activities and comply with these
Exclusion criteria
Exclusion criteria: PwID: 1. Using cochlear implant(s) 2. Established current diagnosis of psychogenic non-epileptic attacks (dissociative seizures) without any epileptic seizures 3. Frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleepwalking, night terrors) 4. Participants involved in therapies with medical devices that deliver electrical energy into the area around the implant 5. Participants at high risk of surgical complications, such as active systemic infection and haemorrhagic disease 6. Participants who are allergic to the local anaesthetics used during implantation 7. Females of childbearing potential who are pregnant or intend to become pregnant throughout the study 8. Participants who have an infection at the site of device implantation 9. Participants who operate MRI scanners or are planning to have an MRI scan during the study period 10. Participants with a profession/hobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). NB: diving/snorkelling is allowed to 5 meters of depth 11. Participants with a profession/hobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing) 12. Any other serious medical condition that in the opinion of the Chief Investigator would be incompatible with participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants’ acceptability of real-world implementation with 24/7 EEG SubQ Solution: 1. Adherence: participants’ percentage wear time with 24/7 EEG SubQ, across the study period of 6 months 2. Usability: average score at 6 months (before explantation) on System Usability Scale (SUS) 3. Qualitative results from semi-structured focus groups measured at 6 months Timepoint(s): 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety: number of adverse events related to the use of the device (adverse device effect [ADE]) during the study period 2. Diagnostic accuracy: within-participant correlation between seizure counts per month from participant-reported seizure diary and occurrences per month (derived from EEG expert review and annotation of 24/7 EEG SubQ EEG data), across the 6 months of the study 3. Quality of life measured using HoNOS-ID at V1 (before implantation), 3 and 6 months (before explantation) 4. Behaviour changes measured using Aberrant Behavior Checklist at V1 (before implantation), 2 and 6 months (before explantation) 5. Stakeholder experience (feasibility) measured using qualitative semi-structured focus groups with PwID/family members/carers at V1 (before implantation), 2 and 6 months 6. Diagnostic accuracy: comparison of retrospective seizure diary and seizure diary data reported across the study period 7. Impact on clinical decisions measured using UNEEG Device Questionnaire –‘HCP Epilepsy management plan’, ‘HCP Management’, ‘HCP Insight’ and ‘HCP Communication’ filled out after each consultation and feedback visit 8. Healthcare provider insights measured using UNEEG Device Questionnaire - ‘HCP Insight’ at 6 months (before explantation) 9. HCP communication measured using UNEEG Device Questionnaire ‘HCP Communication’ at 6 months (before explantation) 10. Potential of 24/7 EEG SubQ Monitoring measured using UNEEG Device Questionnaire ‘Potential of 24/7 EEG SubQ at 8 months (before explantation) 11. Ease of use measured using UNEEG Device Questionnaire ‘PWE Ease of use’ at 6 months (before explantation) 12. Impact on everyday life measured using UNEEG Device Questionnaire ‘PWE Everyday life’ at 6 months (before explantation) 13. Number of device deficiencies across the study period (6 months) provided by UNEEG Medical | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed