---
title: Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
nct_id: NCT07010276
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: The Hospital for Sick Children
study_type: INTERVENTIONAL
primary_condition: Epilepsy; Seizure
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07010276.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07010276"
ct_last_update_post_date: 2025-06-12
last_seen_at: "2026-05-12T06:01:49.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms

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

**NCT ID:** [NCT07010276](https://clinicaltrials.gov/study/NCT07010276)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** The Hospital for Sick Children
- **Conditions:** Epilepsy; Seizure
- **Start Date:** 2025-11-24
- **Completion Date:** 2027-12-31
- **CT.gov Last Update:** 2025-06-12

## 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

## 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.

## Eligibility

- **Minimum age:** 5 Years
- **Maximum age:** 17 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **VNS Treatment** (ACTIVE_COMPARATOR) — Patients in the VNS treatment arm will undergo surgical VNS implantation.
- **DBS Treatment** (ACTIVE_COMPARATOR) — Patients in the DBS treatment arm will undergo surgical DBS implantation.

## Interventions

- **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

- **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.
- **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
- **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.
- **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

- **Hague Seizure Severity Scale (HASS) - parent-perception scale** _(time frame: 1 year)_
- **Seizure Severity Questionnaire (SSQ)** _(time frame: 1 year)_
- **Pediatric Quality of Life Inventory (PedsQL)** _(time frame: 1 year)_
- **CarerQoL - measure of caregiver quality of life** _(time frame: 1 year)_
- **The Child Health Utility 9D (CHU9D)** _(time frame: 1 year)_

## Locations (1)

- The Hospital for Sick Children, Toronto, Ontario, Canada

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the hospital for sick children|toronto|ontario|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07010276.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07010276*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*