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Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot

NCT05437393 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-08-28

No results posted yet for this study

Summary

The CADET Pilot will investigate the safety and feasibility of deep brain stimulation (DBS) to treat children with Lennox-Gastaut syndrome using a novel DBS device (Picostim DyNeuMo-1).

Following a 30-day preoperative/baseline assessment phase, all children will have a neurosurgical procedure to implant the device. Implantation will be followed by a 30-day phase of no stimulation (the device is off / inactive) and then a six-month phase of active stimulation (the device is on / active).

Conditions

  • Epilepsy
  • Lennox-Gastaut Syndrome, Intractable

Interventions

DEVICE

Deep brain stimulation

Deep brain stimulation of the centromedian nucleus (bilateral)

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • King's College Hospital NHS Trust

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • King's College London

    collaborator OTHER

  • University College, London

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2025-08-26
Completion
2025-08-26

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05437393 on ClinicalTrials.gov