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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Stimulation | Active Comparator | 20 epilepsy patients who were eligible and gave consent according to the inclusion criteria. For active group, tDCS treatment will be 2 mA current strength for 30 minutes. |
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| Sham-Transcranial Direct Current Stimulation | Sham Comparator | 20 epilepsy patients who were eligible and gave consent according to the inclusion criteria. For the sham group, the current will increase to 2mA in 10 seconds, continue for the 30s, then decrease to 0 in 10 seconds and cut off. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes 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. | 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. | 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. | 3 months follow-up after tDCS |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the 1st week and 12th week of follow-up after tDCS |
| Depression Anxiety and Stress Scale 21 (DASS-21) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ezgi Tuna Erdoğan, Assist Prof. | Contact | +90 533 643 4749 | ezerdogan@ku.edu.tr | |
| Sacit Karamürsel, Professor | Contact | skaramursel@ku.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Ezgi Tuna Erdoğan, Assist Prof. | Koç University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koc University | Recruiting | Istanbul | Sarıyer | 34450 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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. |
| 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. | 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. | At the 1st week and 12th week of follow-up after tDCS |