Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures
Condition: Epilepsy
MeSH terms: Seizures
Intervention: Vagus Nerve Stimulation (VNS) Therapy; Anti-Epileptic Drug (AED)
Intervention description: Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.; Subject has tried at least 2 appropriate AEDs tested to tolerance or to blood levels at upper end of the target range of which at least 2 had been tolerated at normal doses.
Intervention MeSH terms: Anticonvulsants
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a randomized study designed to compare long-term treatment outcomes in pediatric
      patients with refractory seizures treated with VNS (Vagus Nerve Stimulation) Therapy versus
      anti-epileptic drugs (AEDs). Seizure reduction, quality of life measures, and side effect
      profiles will be evaluated. The results of this study will provide controlled comparative
      data to better guide physicians in determining the best overall treatment strategy for
      patients with seizures who have failed initial AED therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Refractory seizures

          2. Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance
             or to blood levels at upper end of the target range of which at least 2 have been
             tolerated at normal dose;

          3. Having at least 3 appropriate AEDs left to try

          4. Having his/her current AED medication at an optimal dose at baseline

          5. At least three seizures per month (average over 2 months prior to admission),
             excluding absences.

          6. No more than four (4) weeks between seizures (over 2 months prior to admission)

          7. Age 17 years or less

          8. Having been evaluated for epilepsy surgery and resective surgery not felt indicated or
             patient/parents/legal guardian declined.

          9. Patient is a male or patient is a nonpregnant female adequately protected from
             conception. Females of childbearing potential must use an acceptable method of birth
             control. Abstinence is an acceptable means of birth control

         10. Patient or legal guardian understands study procedures and has voluntarily signed an
             informed consent in accordance with institutional policies.

        Exclusion Criteria:

          1. Having tried less then 2 AEDs tested to tolerance or to blood levels at upper end of
             the target range of which at least 2 have been tolerated at normal doses in the
             patient's lifetime

          2. A progressive neurological condition (e.g. brain tumor etc.)

          3. Inability of the parents or reluctance of the child to comply with the frequency of
             clinic visits during the treatment phase

          4. Patient has a history of noncompliance for seizure diary completion.

          5. Patient has taken an investigational drug within a period of five times the mean
             elimination half-life of the investigational drug plus two weeks.

          6. Patient is currently using another investigational device or drug.

          7. Patient is likely to require a whole body Magnetic resonance imaging (MRI) after VNS
             Therapy device implantation. (Refer to the Physician's Manual for the NCP Generator
             for additional information on the use of MRI.)

          8. Patient is currently receiving or likely to receive short-wave diathermy, microwave
             diathermy, or therapeutic ultrasound diathermy after implantation (Refer to
             Physician's Manual for the VNS (Vagus Nerve Stimulation) Therapy device for additional
             information on the contraindicated use of diathermy).

          9. Patient was previously enrolled in this or any other VNS Therapy device Study.

         10. Patient has an active peptic ulcer

         11. Patient has another unstable medical condition likely to precipitate seizures and make
             it difficult to evaluate to evaluate efficacy (e.g. diabetes)

         12. Patient has had a unilateral or bilateral cervical vagotomy.

         13. Patient is pregnant at the time of enrolment.