← Back to Search

Procedure

Deep Brain Stimulation for Drug-Resistant Epilepsy (DBSpostVNS Trial)

N/A
Waitlist Available
Led By George Ibrahim
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed post surgery up to 1 year
Awards & highlights

DBSpostVNS Trial Summary

This trial is comparing DBS to VNS in children with failed VNS who have drug-resistant epilepsy.

Who is the study for?
This trial is for children aged 8 to under 18 with drug-resistant epilepsy who have not seen improvement after using two anti-epileptic medications and vagal nerve stimulation (VNS). Participants need a re-diagnosis by a neurologist, must be able to follow the study's procedures for a year, and have consent from parents or guardians. Those unable to return for follow-ups or with substance abuse issues, or MRI contraindications cannot join.Check my eligibility
What is being tested?
The study compares deep brain stimulation (DBS) effectiveness against continued optimization of VNS in children whose seizures didn't improve with VNS. It's a non-blinded trial involving 50 patients across multiple centers, assessing which treatment better controls epilepsy symptoms.See study design
What are the potential side effects?
While specific side effects are not listed here, DBS can generally cause headache, seizure, confusion, difficulty concentrating, stroke-like symptoms and hardware complications like infection at the implantation site.

DBSpostVNS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 8 and 17 years old.
Select...
I have epilepsy that didn't improve after trying two different medications.
Select...
My seizures have not improved after a year or more of vagal nerve stimulation therapy.
Select...
I am between 8 and 17 years old.
Select...
My epilepsy hasn't improved after trying two different medications.
Select...
My vagal nerve stimulation treatment did not work.

DBSpostVNS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed post surgery up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed post surgery up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Seizure reduction after DBS surgery
Seizure reduction after VNS surgery
Secondary outcome measures
Change in parent-perceived seizure severity
Change in patient-perceived seizure severity
Change in self-reported quality of life

DBSpostVNS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DBS TreatmentExperimental Treatment1 Intervention
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.
Group II: Continued VNS (control)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep brain stimulation
2010
Completed Phase 3
~380

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,768 Total Patients Enrolled
10 Trials studying Epilepsy
1,734 Patients Enrolled for Epilepsy
St. Justine's HospitalOTHER
196 Previous Clinical Trials
79,004 Total Patients Enrolled
George IbrahimPrincipal InvestigatorThe Hospital for Sick Children

Media Library

Deep Brain Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04181229 — N/A
Epilepsy Research Study Groups: DBS Treatment, Continued VNS (control)
Epilepsy Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT04181229 — N/A
Deep Brain Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04181229 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research still have the capacity to accept additional participants?

"Affirmative. The records hosted on clinicaltrials.gov confirm that this medical trial, initially posted on November 25th 2019, is actively searching for volunteers. Approximately 50 people must be recruited from a single centre."

Answered by AI

How many individuals are eligible to join this clinical exploration?

"Affirmative. According to data on clinicaltrials.gov, this trial is actively seeking participants and was initially posted on November 25th 2019 with the most recent update being May 11th 2022. A total of 50 patients are needed from 1 medical centre for enrolment in this study."

Answered by AI

Does this trial cater to those aged 65 and over?

"To qualify for this trial, applicants must be between 8 and 18 years old. 104 clinical trials are currently conducted for the under-18 demographic, while an additional 165 focus on those above 65 yrs of age."

Answered by AI

Is it feasible for me to join the research endeavor?

"This clinical trial is searching for 50 children between the ages of 8 and 18 who have been diagnosed with drug-resistant epilepsy. To qualify, they must be male or female and have unsuccessfully tried two anti-epileptic medications (Kwan et al. 20093). Additionally, their legal guardians/caregivers need to provide consent, they must comply with all testing protocols & follow-ups over a 12 month period post study completion, and finally vagal nerve stimulation should not have yielded improved results at least 1 year following its initiation in order to fulfill eligibility criteria."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
How old are they?
18 - 65
What site did they apply to?
The Hospital for Sick Children
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Deep Brain Stimulation Post Failed Vagal Nerve Stimulation
George Ibrahim 2019. "Deep Brain Stimulation Post Failed Vagal Nerve Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04181229.
~5 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top