Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The Hospital for Sick Children
Toronto, Ontario, Canada
McHugh Scale for outcome measure after Vagal Nerve Stimulation
The McHugh Scale is a system used by doctors to assess how much a patient's seizures have improved after receiving Vagal Nerve Stimulation (VNS) therapy. Similar to the Engel Scale for epilepsy surgery, it categorizes outcomes into different classes based on the percentage reduction in seizure frequency, helping to standardize the evaluation of VNS treatment effectiveness.
Time frame: 1 year
Engel Epilepsy Surgery Outcome Scale
The Engel Epilepsy Surgery Outcome Scale is a common way doctors classify how well epilepsy surgery worked for a patient. It uses different classes (I, II, III, IV) to describe the reduction in seizures after surgery, ranging from being completely seizure-free to having no worthwhile improvement. Class I: Seizure-free Class II: Rare seizures Class III: Significant improvement but not seizure-free Class IV: No improvement or worse
Time frame: 1 year
ILAE Classification
he ILAE Classification is a standardized system used by doctors worldwide to precisely describe and categorize seizures and epilepsy. It helps them understand where a seizure starts in the brain, if a person's awareness is affected, and what symptoms occur, which then guides the best treatment plan.
Time frame: 1 year
Quality of Life in Childhood Epilepsy Questionnaire (QOLCE)
The QOLCE is designed to evaluate the health-related quality of life specifically in children with epilepsy, covering various aspects impacted by their condition.
Time frame: 1 year
Hague Seizure Severity Scale (HASS) - parent-perception scale
The HASS is a patient-reported outcome measure used to quantify the overall severity of epileptic seizures, considering aspects like seizure type, frequency, and impact.
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Time frame: 1 year
Seizure Severity Questionnaire (SSQ)
The SSQ is a self-report questionnaire that assesses the severity of epileptic seizures based on the patient's perception of their seizures and their impact on daily life.
Time frame: 1 year
Pediatric Quality of Life Inventory (PedsQL)
A parent questionnaire designed to evaluate health-related quality of life in children. Scores range from 0 to 92, with higher scores indicating poorer quality of life.
Time frame: 1 year
CarerQoL - measure of caregiver quality of life
This instrument measures the subjective well-being and quality of life experienced by informal caregivers, focusing on both the positive and negative impacts of their caregiving role.
Time frame: 1 year
The Child Health Utility 9D (CHU9D)
The Child Health Utility 9D (CHU9D) is a survey for kids and teens (ages 7-17) that asks simple questions about their health and how they feel. This helps us understand their overall "quality of life" and allows researchers to compare the benefits of different treatments by measuring "Quality-Adjusted Life Years" (QALYs), which is like getting a score for how healthy and long a life someone lives.
Time frame: 1 year