Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms (NCT07010276) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms
Canada20 participantsStarted 2025-11-24
Plain-language summary
Deep Brain Stimulation vs. Vagus Nerve Stimulation for the Treatment of Drug-Resistant Epilepsy and Epileptic Spasms in Children: A Randomized Control Trial
Who can participate
Age range5 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
McHugh Scale for outcome measure after Vagal Nerve Stimulation
Timeframe: 1 year
2
Engel Epilepsy Surgery Outcome Scale
Timeframe: 1 year
3
ILAE Classification
Timeframe: 1 year
4
Quality of Life in Childhood Epilepsy Questionnaire (QOLCE)