Epilepsy Nervous System Diseases
Conditions
Interventions
This is a prospective, single-centre comparative feasibility study. We plan to recruit 15 children, aged 4 years and over, already scheduled for a routine 3-5 day inpatient stay for video-EEG (vEEG) m
Sponsors
University Hospitals Bristol and Weston NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
4 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Children aged 4-18 years 2. Referred to the Children's Epilepsy Surgery Service (CESS) at University Hospitals Bristol & Weston for inpatient vEEG monitoring 3. For the qualitative interviews: parents/carers of enrolled children and clinical staff (neurologists, neurophysiologists, nurses) involved in their care
Exclusion criteria
Exclusion criteria: 1. Evidence of significant scalp swelling or injury (e.g., cuts, infections) 2. Known skin allergies to medical adhesives 3. Co-enrolment in another clinical study if their clinical team believes that this could impact the study results or cause undue burden 4. If the clinical care team deems it inappropriate for them to be approached about the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic accuracy of the Clic EEG device, measured by comparing the data captured with video electroencephalography recordings, in particular noting if the same data is captured and, if so, to the same degree and in the same areas of the brain, determined at the end of each monitoring episode | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Signal power, quality and reliability of vEEG recordings and Clic EEG recordings, measured using spectral analysis (analysis of the different frequencies) at the end of each inpatient episode. 2. Usability of the device, measured by asking five participants/parents/carers to complete short questionnaires on the ease of using the device at the end of each hospital inpatient stay. They will also be invited to participate in a qualitative interview after the participant is discharged from hospital. 3. Usability of the devices, measured by asking five healthcare professionals who are involved in the participants' care to complete a questionnaire and participate in a qualitative interview after caring for study participants in receipt of the intervention. 4. The safety of the Clic EEG device, measured using safety data and any serious adverse events occurring during the study period. | — |
Countries
England, United Kingdom
Contacts
Public ContactRebecca Houlihan
Outcome results
None listed