UnknownPhase 2/3

Does VNS Interact With the Serotonergic and Immune System in Children With Intractable Epilepsy?

Netherlands45 participantsStarted 2006-03

Plain-language 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. To evaluate tolerability and effectiveness of VNS in children with intractable epilepsy and cognitive and behavioural problems in a controlled study. 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. To link the therapeutic effect of VNS to changes in the serotonin (5HT) metabolic pathway. In addition the investigators hope to detect some markers of immune and neurotransmitter function that enable us to predict 1) Neuronal cell loss in relation to cognitive decline 2) the response to therapeutic treatment of VNS. Hypothesis: The investigators aim to explore neuronal correlates for cognitive morbidity in children with intractable epilepsy and to relate this to morphologic changes, biochemical markers, and to epilepsy characteristics. Correction of the "stressed" pro-inflammatory status of monocytes/macrophages via an electrical stimulation of the vagus nerve will prevent/ameliorate seizures as well as behavioural mood symptoms in children with refractory epilepsy, characterized by the "pro-inflammatory monocyte signature"

Who can participate

Age range

4 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

seizure frequency reduction of 50% or more

Timeframe: after 3 and 6 months

Trial details

NCT IDNCT01378611

SponsorEpilepsiecentrum Kempenhaeghe

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-03

View on ClinicalTrials.gov More Refractory Epilepsy in Children trials