Deep Brain Stimulation Post Failed Vagal Nerve Stimulation (DBSpostVNS)
Epilepsy, Drug Resistant
About this trial
This is an interventional treatment trial for Epilepsy, Drug Resistant
Eligibility Criteria
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.
Sites / Locations
- The Hospital for Sick ChildrenRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
DBS Treatment
Continued VNS (control)
Patients in the treatment arm will receive DBS of bilateral centromedian nucleus (2 electrodes per patient). DBS is a standard of care treatment option for drug-resistant epilepsy patients who have previously failed VNS at 12 months or more after instigation and optimization of therapy.
For the control arm, the patients will be monitored for one year with the same standard assessments used for the measurement of seizure frequency and severity. No changes will be made to these patients' treatment plan. These patients will be placed on a wait list for CM-DBS treatment of seizures if that is the desire of the patient and/or their family. After the 12 months of observation, these patients can choose to undergo DBS surgery.