CompletedNot Applicable

Deep Brain Stimulation Post Failed Vagal Nerve Stimulation

Canada25 participantsStarted 2019-11-25

Plain-language summary

This is a multicenter, non-blinded, patient preference comparative trial for efficacy of deep brain stimulation (DBS) on drug-resistant epilepsy compared to continued vagal nerve stimulation (VNS) optimization in children with failed VNS. The two conditions being compared are therefore DBS (treatment) versus VNS (control). Fifty (50) patients will be recruited and enrolled in this pilot study (25 from The Hospital for Sick Children and 50 from CHU Sainte-Justine).

Who can participate

Age range8 Years – 18 Years

SexALL

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Inclusion criteria

✓. Female or Male patients 8 years of age and over but not including 18 year olds.
✓. 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.
✓. Failure of vagal nerve stimulation, defined as the same or increased frequency and severity of seizures at 12 months or more after instigation and optimization of therapy. Failure is defined objectively and subjectively. Objective evidence includes caregiver logs, clinician assessment, or neuromonitoring if the clinician has documented a baseline status prior to instigation of vagal nerve stimulation. Subjective measures include family or patient opinion that seizure frequency or severity has not improved.
✓. Parents or legal guardians, including caregivers, who 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.

What they're measuring

Seizure reduction after DBS surgery

Timeframe: Assessed post surgery up to 1 year

Seizure reduction after VNS surgery

Timeframe: Assessed post surgery up to 1 year

Trial details

NCT IDNCT04181229

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-31

View on ClinicalTrials.gov More Epilepsy, Drug Resistant trials