Who is eligible for clinical trial NCT07010276?

Participants must meet protocol criteria for Epilepsy; Seizure. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07010276 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-06-09

Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms (NCT07010276)

🟡 Not Yet Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: The Hospital for Sick Children

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (9 items).

Location: The Hospital for Sick Children — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

The Hospital for Sick Children — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗