Deep Brain Stimulation Post Failed Vagal Nerve Stimulation

NCT04181229 | Completed

• 1 other identifier: REB1000063803
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Epilepsy, Drug Resistant

Outcome Measures

Primary Outcomes (2)

• Seizure reduction after DBS surgery

  Measured by the Class on the Engel Epilepsy Surgery Outcome Scale, where: Class I: Free of disabling seizures IA: Completely seizure-free since surgery IB: Non disabling simple partial seizures only since surgery IC: Some disabling seizures after surgery, but free of disabline seizures for at least 2 years ID: Generalized convulsions with antiepileptic drug withdrawal only Class II: Rare disabling seizures ("almost seizure-free") IIA: Initially free of disabling seizures but has rare seizures now IIB: Rare disabling seizures since surgery IIC: More than rare disabling seiuzres after surgery, but rare seizures for at least 2 years IID: Nocturnal seizures only Class III: Worthwhile improvement IIIA: Worthwhile seiuzre reduction IIIB: Prolonged seiuzre-free intervals amounting to greater than half the follow-up period, but not less than 2 years Class IV: No worthwhile improvement IVA: Significant seizure reduction IVB: No appreciable change IVC: Seizures worse

  Assessed post surgery up to 1 year

• Seizure reduction after VNS surgery

  Measured by the Class on the McHugh Scale, where: Class I (80-100% reduction in seizure frequency) Class II (50-79% reduction in seizure frequency) Class III (\< 50% reduction in seizure frequency) Class IV (Magnet benefit only) Class V (No improvement)

  Assessed post surgery up to 1 year

Secondary Outcomes (3)

• Change in patient-perceived seizure severity

  Assessed pre surgery and post surgery up to 1 year

• Change in parent-perceived seizure severity

  Assessed pre surgery and post surgery up to 1 year

• Change in self-reported quality of life

  Assessed pre surgery and post surgery up to 1 year

Study Arms (2)

DBS Treatment

EXPERIMENTAL

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.

Procedure: Deep brain stimulation

Continued VNS (control)

NO 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.

Interventions

Deep brain stimulation PROCEDURE

Patients will receive surgical implantation of the Medtronic DBS device (Device # 37601). Two (2) electrodes will be implanted bilaterally in the centromedian nucleus.

DBS Treatment

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• St. Justine's Hospital: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• George Ibrahim

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Treatment arm - DBS Control arm - Continued VNS (optimization)

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 29, 2019
• Study Start: November 25, 2019
• Primary Completion: March 31, 2023
• Study Completion: August 30, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)