The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial

Not Applicable

Not yet recruiting

• Conditions: Lennox Gastaut Syndrome (LGS)

• Registration Number: NCT06924086
• Lead Sponsor: University College, London

Brief Summary

The CADET Trial will investigate the effectiveness of deep brain stimulation (DBS) to reduce the frequency of seizures in children with Lennox-Gastaut syndrome (LGS). The CADET Trial will use a non-CE/UKCA marked device - the Picostim DBS system.

The SMART-DBS study is a sub-study of the CADET Trial. SMART-DBS will investigate the application of adaptive DBS for the treatment of children with LGS. Children will be recruited after they exit from either the prior 'CADET Pilot Study' or 'CADET Trial' - meaning that these children will already be receiving therapy with an already implanted Picostim device.

Detailed Description

All participants will complete a 4 week baseline assessment phase, then surgical implantation of the Picostim device and then a 4 week recovery phase. The participants will thereafter be randomised (1:1) and double-blinded to either an 'early stimulation' (DBS device switched on) or an 'delayed stimulation' (DBS device switched off) arm. Children allocated to receive early stimulation will complete 36 weeks of immediate active stimulation and children allocated to delayed stimulation will complete 12 weeks of inactive stimulation followed by 24 weeks of active stimulation.

The primary endpoint for all participants in the trial will be following 24 weeks of active stimulation. Secondary outcomes will be compared between the early and delayed stimulation arms following the first 12 weeks of the controlled phase.

The SMART-DBS study will recruit participants from the CADET Trial and the preceding CADET Pilot study. In both the CADET Trial and CADET Pilot studies, participants were fitted with the Picostim device and the device remains active. Participants who potentially meet the eligibility criteria will be provided with the PIS to consider participation in the adaptive DBS study.

Study Timeline

• Study First Submitted: 2025-03-28
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Study Start: 2025-06-01
• Primary Completion: 2028-01-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Seizure frequency reduction	24 weeks of active stimulation compared to baseline	Seizure frequency reduction measured on carer-recorded seizure diaries

Secondary Outcome Measures

Name	Time	Method
Seizure frequency	8-12 weeks following randomisation between the active and inactive stimulation arms	Seizure frequency reduction measured on scalp EEG
Seizure severity	24 weeks of active stimulation relative to baseline and comparison 12 weeks following randomisation between the active and inactive arms	Seizure severity (according to the Hague Seizure Severity Scale). The HSSS scores range from 13 (least severe) and to 53 (most severe).
Quality of life (PedsQL)	After 24-weeks of active stimulation, and 12 weeks following randomisation between the active and inactive stimulation arms	The PedsQL (Pediatric Quality of Life Inventory) questionnaire provides a quantitative score ranging from 0 (worst possible QoL) to 100 (best possible QoL) (https://www.pedsql.org/).
Quality of life (IPES)	After 24-weeks of active stimulation, and 12 weeks following randomisation between the active and inactive stimulation arms	The Impact of Pediatric Epilepsy Scale (IPES) is a 12-item questionnaire that is answered by the carers of children with epilepsy that, as titled, aims to objectively measure the burden that epilepsy has on the child's life. The IPES scores range from 0 (lowest impact of epilepsy on the participant) to 33 (highest impact of epilepsy on the participant).