G40
Conditions
Interventions
Group 1: Experimental:
Individually optimized multi-channel transcranial direct current stimulation (mc-tDCS):
2 x 20 min of mc-tDCS with 20 min pause inbetween at 4 mA distributed over multiple elec
Sponsors
University of Münster, Institute for Biomagnetism and Biosignalanalysis
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - Adult male and female subjects between 18 and 70 years of age - New patients, but also previously studied patients who are not yet seizure-free - Classification of the epileptogenic foci and possibility of a high quality reconstruction of the epileptogenic zone, i.e. sufficient ictal and interictal measured and reconstructable activity of sufficient signal-to-noise ratio, sufficient overlap of the irritative zone with the epileptogenic zone and with possible lesions in the MRI - Number and severity of seizures occurring and how they might be affected by stimulation and/or surgery. - Sufficiently high average weekly seizure frequencies. - Usually there is enough time between diagnosis and surgery that mc-tDCS can be interposed. However, if there is not enough time, surgery should not normally be postponed. For the tDCS this would mean a drop out, but the diagnostic part of PerEpi could be successfully validated. However, if the treating physicians decide that the surgery will be delayed in order to enable mc-tDCS first, then this would be discussed and considered with the patient) Additional inclusion criteria include: - countable seizures - Pat. or relatives notice the seizures - Patients or relatives are able to keep a seizure diary. - Patients are particularly eligible if either no surgery / resection can be offered after pre-surgical diagnosis or if the patient does not (yet) want surgery. - Severity of seizures: motor or non-motor; conscious seizures or not (following the terminology in the current seizure classification of the ILAE); seizures with or without loss of body postural control.
Exclusion criteria
Exclusion criteria: - Seizures that cannot be counted - Seizures that are not noticed by the patient or relatives to a relevant extent. - Metal in or on the body - Head too large for combined EEG/MEG measurement Drop-outs could be caused by too much movement in EEG/MEG/MRI, so that data quality is too poor or that targeting is not possible (e.g. because not enough ictal and interictal activity could be measured or because the reconstructions cannot be trusted due to poor signal-to-noise ratio). We will try to replace the drop outs with more incoming patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success of the improved localization of the epileptogenic zone and the individualized mc-tDCS stimulation or surgery is measured by the epileptic activity (ictal and interictal) outcome after the therapy (see attached study protocol). We try to follow the patients, if possible, for two years and document the outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Remaining seizure frequency, severity, and type. - Side effects of stimulation or surgery - Evaluation of the risks of stimulation or surgery - Costs of the chosen therapy - Use of the methodology for basic brain research | — |
Countries
Germany
Contacts
Public ContactCarsten Wolters
University of Münster, Institute for Biomagnetism and Biosignalanalysis
Outcome results
None listed