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Diepe hersenstimulatie bij epilepsie: wat bepaalt het effect?


- candidate number17613
- NTR NumberNTR4562
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-apr-2014
- Secondary IDsMETC azM/UM nr. 13-2-028 
- Public TitleDiepe hersenstimulatie bij epilepsie: wat bepaalt het effect?
- Scientific TitleStimulation of the anterior thalamic nucleus in refractory epilepsy: Neurophysiological aspects and long term effects on inflammation
- ACRONYMDBSEPI
- hypothesisElectrophysiological connectivity between ATN and cortical zones involved in the epilepsy of the patient in question relates to treatment response
- Healt Condition(s) or Problem(s) studiedEpilepsy
- Inclusion criteria Medically refractory epilepsy
No possibility for resective epilepsy surgery
Incapacitating epilepsy or seizures
Pattern of seizures has to be fit for appropriate assessment
Minimum age 18 years
Patient or caregiver must be able to register seizures in some way
- Exclusion criteria Underlying malignancies, whenever life expectancy is lower than 2 years
Co-medication with anti-inflammatory drugs or systemic diseases with inflammation
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2014
- planned closingdate1-jul-2018
- Target number of participants0
- InterventionsThis study is a non-interventional study
- Primary outcomeWe use clinical response to the treatment as a primary endpoint. We will distinguish two groups: Patients with a poor response and patients with a good to excellent response.
- Secondary outcome1. The degree of electrophysiological connectivity between the ATN and the cerebral cortex as measured directly in the phase postoperatively (single measurement)
2. The profile (increase/decrease) of inflammation parameters in peripheral blood over the 2 years after start of the treatment (thus over 4 blood samples in 2 years)
- Timepoints0, postoperative, 3, 12, 24 months.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. R. Rouhl
- CONTACT for SCIENTIFIC QUERIESDr. R. Rouhl
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD29-apr-2014 - 3-jun-2014


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