Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms (DBS-VNS-ES)

The Hospital for Sick Children

Status: Begins enrollment in 5 months

Conditions: Epilepsy; Seizure

Treatments: Device: DBS Arm; Device: VNS arm

Study type: Interventional

Funder types: Other

Identifiers

NCT07010276

1000080101

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

VNS Treatment

Active Comparator group

Description:

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

Treatment:

Device: VNS arm

DBS Treatment

Active Comparator group

Description:

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

Treatment:

Device: DBS Arm