Clinical trial NCT07010276: Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy; Seizure
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: McHugh Scale for outcome measure after Vagal Nerve Stimulation
timeFrame: 1 year
measure: Engel Epilepsy Surgery Outcome Scale
timeFrame: 1 year
measure: ILAE Classification
timeFrame: 1 year
measure: Quality of Life in Childhood Epilepsy Questionnaire (QOLCE)
timeFrame: 1 year
Secondary outcomes:
measure: Hague Seizure Severity Scale (HASS) - parent-perception scale
timeFrame: 1 year
measure: Seizure Severity Questionnaire (SSQ)
timeFrame: 1 year
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: 1 year
measure: CarerQoL - measure of caregiver quality of life
timeFrame: 1 year
measure: The Child Health Utility 9D (CHU9D)
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: George M Ibrahim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: