Menu
Not yet recruiting NCT07010276

Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms

No phase Interventional Epilepsy; Seizure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DBS Arm, VNS arm.
Who it may be relevant to
Registry conditions: Epilepsy; Seizure. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Centromedian Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Trial

Overview

Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial

Detailed description

To directly compare the effectiveness and safety of deep brain stimulation (DBS) vs. vagus nerve stimulation (VNS) in children with drug-resistant epilepsy (DRE) or epileptic spasms.

This will be an open, non-blinded randomized control trial. Twenty (20) patients will be recruited and enrolled in this pilot study from SickKids.

Expected study duration is 36-48 months.

Interventions

  • Device DBS Arm
    Patients in the DBS treatment arm will undergo surgical DBS implantation.
  • Device VNS arm
    Patients in the VNS treatment arm will undergo surgical VNS implantation.

Primary outcome measures

  • McHugh Scale for outcome measure after Vagal Nerve Stimulation [Time frame: 1 year]
  • Engel Epilepsy Surgery Outcome Scale [Time frame: 1 year]
  • ILAE Classification [Time frame: 1 year]
  • Quality of Life in Childhood Epilepsy Questionnaire (QOLCE) [Time frame: 1 year]
Secondary outcome measures (5)
  • Hague Seizure Severity Scale (HASS) - parent-perception scale [Time frame: 1 year]
  • Seizure Severity Questionnaire (SSQ) [Time frame: 1 year]
  • Pediatric Quality of Life Inventory (PedsQL) [Time frame: 1 year]
  • CarerQoL - measure of caregiver quality of life [Time frame: 1 year]
  • The Child Health Utility 9D (CHU9D) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Female or Male patients 5 years of age and over (17 and 11 months), not including 18 years old
  • Diagnosis of drug-resistant epilepsy with failure after trial of two anti-epileptic
  • Medications (as defined by Kwan et al. 20093). All children screened for entry into the study will be re-diagnosed by a neurologist prior to entry.
  • Main seizure type includes epileptic spasms and tonic spasms, as confirmed by electroencephalography.
  • Parents or legal guardians, including caregivers, are informed and able to give written consent.
  • Ability to comply with all testing, follow-ups and study appointments and protocols for 12 months following the end of the duration of the study

Exclusion criteria

  • Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
  • Any contraindication to MRI scanning. A preoperative MRI scan is essential to
  • Planning DBS and therefore any contraindication to MRI is a contraindication to enrollment in the study.
  • Unwillingness or inability to return to SickKids for follow-up visits.
  • Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
  • Pregnancy
  • Inability to communicate adequately in English in order to complete the baseline and follow-up questionnaires.
  • A co-morbid condition that requires frequent MRI scanning as part of the patient's regular care.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • The Hospital for Sick Children — Toronto

Identifiers

NCT: NCT07010276 · 1000080101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗