NCT01378611

Brief Summary

Clinical randomized controlled observer blinded add-on design. Additionally there will be a non-controlled follow-up phase of the study. Children (Age 4-18 years) with intractable epilepsy, and not eligible for resective surgery will be treated with VNS. Aim of the study:

  1. 1.To evaluate tolerability and effectiveness of VNS in children with intractable epilepsy and cognitive and behavioural problems in a controlled study.
  2. 2.To evaluate the effect of VNS on the immune system which, in its turn, will lead to changes in the serotonin metabolic pathway
  3. 3.To link the therapeutic effect of VNS to changes in the serotonin (5HT) metabolic pathway.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

6 years

First QC Date

June 14, 2011

Last Update Submit

June 28, 2011

Conditions

Refractory Epilepsy in Children

Keywords

intractable childhood epilepsyVNSimmune system

Outcome Measures

Primary Outcomes (1)

  • seizure frequency reduction of 50% or more

    Seizure frequency is measured by using seizure diaries

    after 3 and 6 months

Study Arms (2)

active control group

PLACEBO COMPARATOR

The active control group is stimulated with: Output current 0.25 milliampere, Pulse width 0.1 milliseconds, Frequency 1 Hz, Duty cycle: 14 sec on 60 min off (duty cycle \<0.5%)

Device: Vagus Nerve Stimulator: Neurocybernetic prothesis NCP, Cyberonics Inc., Webster, TX, USA

treatment group

EXPERIMENTAL

The high stimulation group is stimulated with output current 0.25 milliampere, Pulse width 0.5 milliseconds, Frequency 30 Hz, Duty cycle: 30 sec on 5 min off in the treatment group the current was stepwise increased with two week intervals to the maximally tolerated output current (maximum 1.75 mA).

Device: Vagus Nerve Stimulator: Neurocybernetic prothesis NCP, Cyberonics Inc., Webster, TX, USA

Interventions

Vagus Nerve Stimulator: Neurocybernetic prothesis NCP, Cyberonics Inc., Webster, TX, USADEVICE

The study group is stimulated with the following parameters: Output current 0.25 milliampere (to be ramped up to max. 1.75 milliampere), Pulse width 0.5 milliseconds, Frequency 30 Hz, Duty cycle: 30 sec on 5 min off (duty cycle 10%).

Also known as: vagus nerve stimulation
active control grouptreatment group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Seizures not adequately controlled by anti-epileptic drugs of first or second choice with adequate and stable serum anticonvulsant concentrations
  • Acceptable seizure regulation but intolerable side effects with adequate and stable serum anticonvulsant concentrations
  • Not eligible for epilepsy surgery
  • Age between 4 and 18 years
  • Informed consent

You may not qualify if:

  • Evidence of a progressive cerebral lesion, degenerative disorder, malignancy or a history with malignancy in the past 5 years
  • Unstable medical disease (i.e. cardiovascular, hepatic, renal, musculoskeletal, gastrointestinal, metabolic, endocrine) in the last 2 years
  • Documented history with generalized status epilepticus in the past three months
  • High risks for complications (obstructive respiratory disease, gastric disorders, cardiac I disorders)
  • A history of alcohol or drug abuse, of psychiatric disorder requiring electroconvulsive therapy, chronic use of major tranquillisers (neuroleptics, antidepressants, or MAO inhibitors) in the past 6 months
  • Regularly treatment with antihistamines, metoclopramide or CNS-active compounds
  • Treatment with an experimental drug during the past 30 days
  • Subjects who are schizophrenic or have exhibited any psychotic symptomatology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

Epilepsiecentrum Kempenhaeghe

Heeze, North Brabant, 5591VE, Netherlands

Location

MeSH Terms

Interventions

Vagus Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • A.P. Aldenkamp, Prof

    Epilepsie centrum Kempenhaeghe

    STUDY CHAIR

  • EMJ Cornips, MD,

    Maastricht University Medical Center

    STUDY CHAIR

  • J. Hulsman, PhD

    Epilepsie centrum Kempenhaeghe

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 14, 2011

First Posted

June 22, 2011

Study Start

March 1, 2006

Primary Completion

March 1, 2012

Study Completion

March 1, 2013

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

NL(2)