The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial

NCT06924086 | Not Yet Recruiting DMC

• 1 other identifier: 141268
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lennox Gastaut Syndrome (LGS)

Keywords

epilepsy; deep brain stimulation; Lennox-Gastaut Syndrome; pediatric; paediatric; children

Outcome Measures

Primary Outcomes (1)

• Seizure frequency reduction

  Seizure frequency reduction measured on carer-recorded seizure diaries

  24 weeks of active stimulation compared to baseline

Secondary Outcomes (6)

• Seizure frequency

  8-12 weeks following randomisation between the active and inactive stimulation arms

• Seizure frequency

  24 weeks of active stimulation compared to baseline

• Seizure frequency

  8-12 weeks following randomisation between the active and inactive stimulation arms

• Seizure severity

  24 weeks of active stimulation relative to baseline and comparison 12 weeks following randomisation between the active and inactive arms

• Quality of life (PedsQL)

  After 24-weeks of active stimulation, and 12 weeks following randomisation between the active and inactive stimulation arms

Study Arms (2)

Early stimulation

ACTIVE COMPARATOR

Active stimulation

Device: Deep Brain Stimulation

Delayed stimulation

SHAM COMPARATOR

Inactive stimulation

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

Picostim DBS Device

Delayed stimulation; Early stimulation

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Children enrolled in this study must: * Be 5-14 years of age at consent. * Have a diagnosis of LGS, as determined by: * Slow (\<3.0Hz) spike-and-wave pattern and/or fast wave pattern (tonic seizures) detected on EEG at least six-months prior to the enrolment into the baseline period * History of drop seizures (tonic, atonic, or tonic-clonic) that precedes at least six-months prior to the enrolment into the baseline period * Have experienced at least 10 seizures in the four weeks prior to enrolment. * Have tried and not responded to two or more antiseizure medications prior to enrolment. * Be taking one or more anti-seizure medication(s) at a stable dose for at least the four weeks prior to enrolment. * Have a carer who is willing for their child's maintenance anti-seizure medications and ketogenic diet (if relevant) to be unaltered for the trial duration. * Have a carer who is willing and able to comply with all the requirements of the study, including the completion of the seizure diary and periodic device charging. Children enrolled in this study must not: * Have received prior deep brain stimulation insertion. * Have an active ('on') vagus nerve stimulator (or active within the six months prior to the baseline period). * Have had a change in their anti-seizure medication prescription or stopped their ketogenic diet within the last 4 weeks * Have started or made changes to the prescription of a ketogenic diet within the last 12-weeks * Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible. * Have a bleeding disorder(s). * Have a medical condition(s)/factor(s) that would increase their anaesthetic risk to an unacceptable level. * Have a nickel allergy. * Be pregnant.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College, London: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• King's College Hospital NHS Trust: collaborator
• University of Oxford: collaborator
• King's College London: collaborator

MeSH Terms

Conditions

Lennox Gastaut Syndrome; Epilepsy

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Epileptic Syndromes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Rory J Piper, MRCS, PhD

CONTACT

+44 20 7405 9200; Rory.Piper@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12