An early feasibility study evaluating a novel device for identifying seizure activity in a sample of 15 children

Accessible continuous electroencephalography and swift screening for epilepsy diagnosis and management in children and young people

Registry ID
ISRCTN12324814
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
Enrollment
15
Start date
2026-06-22
Completion date
2026-08-31
Last update
2026-08-17

Conditions

Summary

Epilepsy

Detailed description

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) monitoring. Children admitted for vEEG monitoring, which is a combination of a continuous video recording which provides visual feedback on their seizures alongside electroencephalography recordings, will have four small, stick-on Clic EEG devices applied. Both types of monitoring equipment are worn at the same time. This dual-recording approach allows for a comparison of the data captured by both devices. Clic EEG is a novel wearable EEG medical device designed for remote continuous monitoring over extended periods (up to four days). The Clic EEG devices are applied behind each participant’s ear and on either side of the forehead along the hairline. The devices will be applied by trained neurophysiologists. The devices are single use and are replaced every 48 hours. There is a light on the back of the device indicating when this is necessary. To assess usability, we will use a mixed-methods approach. Following the monitoring period, we will ask parents, carers, and clinical staff to complete validated questionnaires either while still in hospital or in the week following discharge. We will also conduct semi-structured interviews with these groups to gather in-depth feedback on their experience with the Clic EEG device.

Interventions

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

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

Locations

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