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NCT Number: NCT07010276

Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms

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

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Key information

Conditions

Epilepsy; Seizure Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DBS Arm

Device

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

VNS arm

Device

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

Primary outcomes

  1. McHugh Scale for outcome measure after Vagal Nerve Stimulation

    Time frame: 1 year

    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.

  2. Engel Epilepsy Surgery Outcome Scale

    Time frame: 1 year

    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

  3. ILAE Classification

    Time frame: 1 year

    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.

  4. Quality of Life in Childhood Epilepsy Questionnaire (QOLCE)

    Time frame: 1 year

    The QOLCE is designed to evaluate the health-related quality of life specifically in children with epilepsy, covering various aspects impacted by their condition.

Secondary outcomes

  1. Hague Seizure Severity Scale (HASS) - parent-perception scale

    Time frame: 1 year

    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.

  2. Seizure Severity Questionnaire (SSQ)

    Time frame: 1 year

    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.

  3. Pediatric Quality of Life Inventory (PedsQL)

    Time frame: 1 year

    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.

  4. CarerQoL - measure of caregiver quality of life

    Time frame: 1 year

    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.

  5. The Child Health Utility 9D (CHU9D)

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

George M Ibrahim, MD, PhD

CONTACT

[email protected]

416-813-6125

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Acronym: DBS-VNS-ES

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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