The basis of this project is the application of cathodal tDCS in patients with drug-resistant focal epilepsy including patients whose seizures persist after epilepsy surgery, who rejected epilepsy surgery, and/or who are not suitable for surgery. For this purpose, 5-day consecutive cathodal electrical stimulation sessions will be used with personalized electrode montage according to the patient's seizure focus. In this context, the changes in seizures frequency and epileptic discharges will be examined for the first week and 12th week after the tDCS sessions through the seizure diary of the patients and the electroencephalogram (EEG) recordings to be taken. In addition, changes in cognitive functions, mood, and quality of life will be examined in patients after the intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Sponge electrodes 5 x 7 cm in size will be used for tDCS application. The sponge electrodes will be wetted with saline and the cathode electrode will be placed on the seizure focus determined by EEG recording and seizure clinic, while the anode electrode will be placed on the contralateral shoulder-deltoid muscle.
Koc University
Istanbul, Sarıyer, Turkey (Türkiye)
RECRUITINGChanges in epileptic discharge frequency at 1st week after tDCS compared to baseline epileptic discharge frequency
EEG recordings will be obtained after tDCS sessions. Epileptic discharges will be calculated from 30 minutes recordings. EEG will be recorded with scalp electrodes using a 128-channel Natus Quantum (Natus Medical) with a sampling rate 2048 Hz and 21 channels.
Time frame: At the 1st week of follow-up after tDCS
Changes in epileptic discharge frequency at 12th week after tDCS compared to baseline epileptic discharge frequency
EEG recordings will be obtained after tDCS sessions. Epileptic discharges will be calculated from 30 minutes recordings. EEG will be recorded with scalp electrodes using a 128-channel Natus Quantum (Natus Medical) with a sampling rate 2048 Hz and 21 channels.
Time frame: At the 12th week of follow-up after tDCS
Changes in epileptic seizure frequency at 12th week after tDCS compared to baseline (before the tDCS)
The seizure diary of the patients will be recorded for 3 months follow-up after tDCS sessions. The seizure frequency will be evaluated in comparison to pre-tDCS seizure frequency.
Time frame: 3 months follow-up after tDCS
Quality of Life in Epilepsy Inventory (QOLIE-31)
The QOLIE-31 is used to measure quality of life in epilepsy. The scale is scored between 0-100. A high score reflects a high quality of life.
Time frame: At the 1st week and 12th week of follow-up after tDCS
Depression Anxiety and Stress Scale 21 (DASS-21)
The DASS-21 is a self-report scale designed to measure the negative emotional states of depression, anxiety and stress. Individuals read each statement and circle a number 0, 1, 2 or 3 that indicates how much the statement is expressing his/her emotional state over the past week. The scale includes 21 questions and measure depression, stress and anxiety dimensions. A high score on the DASS- 21 indicates an increase in depression, anxiety and stress symptoms.
Time frame: At the 1st week and 12th week of follow-up after tDCS
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by summing the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Time frame: At the 1st week and 12th week of follow-up after tDCS
Epworth Sleepiness Scale
The Epworth Sleepiness Scale can be used to assess daytime sleepiness. It consists of a total of 8 questions. Each question is self-assessed by the patient with a number from 0 to 3. Scores can be interpreted as follows: 0-5 lower normal daytime sleepiness. 6-10 normal daytime sleepiness. 11-12 mild excessive daytime symptoms.
Time frame: At the 1st week and 12th week of follow-up after tDCS
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