Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms (DBS-VNS-ES)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy; Seizure
• Intervention / Treatment: Device: VNS arm; Device: DBS Arm

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: George M Ibrahim, MD, PhD; Phone Number: 416-813-6125; Email: george.ibrahim@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • The Hospital for Sick Children
      • Principal Investigator: George Ibrahim
      • Contact: MyLoi Huynh; Phone Number: 309117 416-813-7654; Email: myloi.huynh@sickkids.ca
      • Contact: Fay Kisteroff; Phone Number: 309014 416-813-7654; Email: fay.kisteroff@sickkids.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VNS Treatment; Patients in the VNS treatment arm will undergo surgical VNS implantation.	Device: VNS arm; Patients in the VNS treatment arm will undergo surgical VNS implantation.
Active Comparator: DBS Treatment; Patients in the DBS treatment arm will undergo surgical DBS implantation.	Device: DBS Arm; Patients in the DBS treatment arm will undergo surgical DBS implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	1 year

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: George M Ibrahim, MD, PhD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Estimated): November 24, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 30, 2025
• First Submitted That Met QC Criteria: May 30, 2025
• First Posted (Actual): June 8, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Seizures
• Other Study ID Numbers: 1000080101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No