THE EFFECT OF VAGUS NERVE STIMULATION ON PRO-AND ANTI-INFLAMMATORY CYTOKINES IN PATIENTS WITH REFRACTORY EPILEPSY

Completed

Conditions: Epilepsy
10039911

Registration Number: NL-OMON29828

Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1) Patients treated with Vagus Nerve stimulation as part of usual patient care
2) Age 18 years or older
3) Informed consent

Exclusion Criteria

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>> 50% seizure reduction </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Demographic data and epilepsy specific data:<br /><br>- age<br /><br>- gender<br /><br>- seizure and epilepsy syndrome classification<br /><br>- duration of epilepsy<br /><br>- seizure frequency (diary)<br /><br>- seizure severity<br /><br>Neuro-immunologic variables (pro-, and anti-inflammatory cytokines and<br /><br>neuroprotective cytokines)<br /><br>Biochemical variables (serotonin metabolites, GABA, glutamate)<br /><br>Endocrine variables (cortisol)<br /><br>Neuropsychologic variables (mood and quality of life)</p><br>