Epilepsy; SeizureDBS-VNS-ESNCT07010276
Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
A study testing DBS Arm and VNS arm in people with Epilepsy; Seizure, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Epilepsy; Seizure
- What is being tested?
- DBS Arm and VNS arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
MyLoi Huynh, 416-813-7654 ext. 309117, myloi.huynh@sickkids.ca
Fay Kisteroff, 416-813-7654 ext. 309014, fay.kisteroff@sickkids.ca
About this study
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
Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial
Read the 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.
- Conditions
- Epilepsy; Seizure
- Being tested
- DBS Arm, VNS arm
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS ArmDevice
Patients in the DBS treatment arm will undergo surgical DBS implantation.
VNS armDevice
Patients in the VNS treatment arm will undergo surgical VNS implantation.
| Study group | Role | What they receive |
|---|---|---|
| VNS Treatment | Active comparator | Patients in the VNS treatment arm will undergo surgical VNS implantation. Receives: Device: VNS arm |
| DBS Treatment | Active comparator | Patients in the DBS treatment arm will undergo surgical DBS implantation. Receives: Device: DBS Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start24 Nov 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy; SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Ibrahim, The Hospital for Sick Children
- Investigators
- George M Ibrahim, MD, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010276
- Sponsor's protocol ID
- 1000080101
- Acronym
- DBS-VNS-ES
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07010276
- Acronym / sponsor ID
- DBS-VNS-ES / 1000080101
- Conditions
- Epilepsy; Seizure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 24 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VNS Treatment | Active comparator | Device: VNS armPatients in the VNS treatment arm will undergo surgical VNS implantation. |
| DBS Treatment | Active comparator | Device: DBS ArmPatients in the DBS treatment arm will undergo surgical DBS implantation. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBS ArmPatients in the DBS treatment arm will undergo surgical DBS implantation. | Device | DBS Treatment |
| VNS armPatients in the VNS treatment arm will undergo surgical VNS implantation. | Device | VNS Treatment |
Primary outcome
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.
5 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George M Ibrahim, MD, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS Arm and VNS arm in people with Epilepsy; Seizure, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George M Ibrahim, MD, PhD (416-813-6125, george.ibrahim@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McHugh Scale for outcome measure after Vagal Nerve Stimulation (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.