Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms

NCT07010276 | Not Yet Recruiting

• 1 other identifier: 1000080101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy; Seizure

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

Secondary Outcomes (5)

• Hague Seizure Severity Scale (HASS) - parent-perception scale

  1 year

• Seizure Severity Questionnaire (SSQ)

  1 year

• Pediatric Quality of Life Inventory (PedsQL)

  1 year

• CarerQoL - measure of caregiver quality of life

  1 year

• The Child Health Utility 9D (CHU9D)

  1 year

Study Arms (2)

VNS Treatment

ACTIVE COMPARATOR

Patients in the VNS treatment arm will undergo surgical VNS implantation.

Device: VNS arm

DBS Treatment

ACTIVE COMPARATOR

Patients in the DBS treatment arm will undergo surgical DBS implantation.

Device: DBS Arm

Interventions

DBS Arm DEVICE

Patients in the DBS treatment arm will undergo surgical DBS implantation.

DBS Treatment

VNS arm DEVICE

Patients in the VNS treatment arm will undergo surgical VNS implantation.

VNS Treatment

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• George M Ibrahim, MD, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George M Ibrahim, MD, PhD

CONTACT

416-813-6125; george.ibrahim@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Neurosurgeon

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

CA (1)