|- candidate number||17973|
|- NTR Number||NTR4616|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-mei-2014|
|- Secondary IDs||iEEGstudy |
|- Public Title||Denkprocessen meten met electroden in de hersenen|
|- Scientific Title||Intracranial registration in patients with refractory epilepsy - an integrative analysis of brain signals in response tot sensory stimuli|
|- hypothesis||To enhance insight on the coding of sensory stimuli by signal analyses|
|- Healt Condition(s) or Problem(s) studied||Epilepsy|
|- Inclusion criteria||• Medically refractory epilepsy |
• Diagnostic workup up till that moment has not led to decline the patient for resective epilepsy surgery
• A suspected (neo-)cortical seizure focus at the surface of the brain
• Planned implantation of intracranial electrodes
• Incapacitating epilepsy or seizures
• Minimum age 18 years
Inclusion criteria for healthy control:
• Voluntary controls will be selected based on the gender and age distribution of the patients programmed for grid implantation surgery.
|- Exclusion criteria||• Patients with (co-existent) psychogenic, non-epileptic attacks, or low IQ (below 70). |
• (post-ictal) psychosis during the registration period will lead to exclusion from the study.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2014|
|- planned closingdate|
|- Target number of participants||0|
|- Interventions||No interventions are planned|
|- Primary outcome||To study the patterns and topographical distribution of the electrical signal generated in cortical neurons during the processing of sensory stimuli (of which the nature will depend on the primary function of the cortical area under investigation) in epileptic patients under intracranial registration.|
|- Secondary outcome|| The secondary objectives are: |
1. To study the phase-amplitude relationship between different frequency bands in the neural signal.
2. To characterize the brain activation patterns during sensory stimulation by fMRI in epileptic patients before the implantation of the electrodes and compare it with the fMRI activation patterns obtained from healthy volunteers.
3. To identify the patterns in the ECoG signal that are correlated with the patterns of activation obtained with fMRI in order to understand better how the neural processes are reflected in neuroimaging studies.
4. To collect quantitative information that can be used for future research projects.
|- Timepoints||7T fMRI scan (presurgical) and postoperative test. No other timepoints. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. R. Rouhl|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R. Rouhl|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||27-mei-2014 - 28-jun-2014|