Health TrialsbyHealthPanel

Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms

ConditionEpilepsy; Seizure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorThe Hospital for Sick Children

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: VNS TreatmentActive comparator 1 intervention
Group B: DBS TreatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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.

Time frame
1 year
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hospital for Sick Children

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: