Cathodal Transcranial Direct Current Stimulation in Patients With Drug-resistant Focal Epilepsy

Cathodal Transcranial Direct Current Stimulation in Patients With Drug-resistant Focal Epilepsy: Randomized Controlled Clinical Trial

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 Overview

• Status: Recruiting
• Conditions: Drug Resistant Epilepsy
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ezgi Tuna Erdoğan, Assist Prof.; Phone Number: +90 533 643 4749; Email: ezerdogan@ku.edu.tr
• Study Contact Backup: Name: Sacit Karamürsel, Professor; Email: skaramursel@ku.edu.tr

Study Locations

• Turkey
  • Sarıyer
    • Istanbul, Sarıyer, Turkey, 34450
      • Recruiting
      • Koc University
      • Contact: Candan Gürses; Email: cagurses@kuh.ku.edu.tr
      • Principal Investigator: Ezgi Tuna Erdoğan
      • Principal Investigator: Candan Gürses
      • Principal Investigator: Sacit Karamürsel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years and older,
• Diagnosed with focal epilepsy with epileptic focus determined according to clinical and electroencephalogram recordings, who have undergone epilepsy surgery but seizures persist, who refuse epilepsy surgery or who are considered unsuitable for surgery,
• Patients who comply with the definition of drug-resistant epilepsy according to ILAE (International League Against Epilepsy Classification) criteria (Patients who have failed to achieve long-term seizure-free status despite at least two appropriate antiepileptic drugs given alone or in combination),
• Minimum 1 or more seizures per month (minimum 3 months),
• No antiepileptic dose change until 3 weeks before the study, stable treatment, and no dose change planned during the study,
• At least 1.5 Tesla MR imaging was performed before the study,
• Signed the informed consent form or the consent form signed by the legal representative,
• EEG was present before the study and all EEG data was accessible,
• Cooperative patients who can speak, understand and communicate in Turkish will be recruited.

Exclusion Criteria:

• The presence of any disease/deformity in the patient that the researchers believe will affect the patient's safety or the reliability of the data to be collected,
• Detection of more than one seizure focus in the patient,
• The patient had a psychogenic non-epileptic seizure attack (Psychogenic Non-epileptic Seizures -PNES) within 2 years prior to the study,
• Having a generalized onset seizure,
• Having had status epilepticus in the last 1 year,
• Presence of any disease, medical condition, or physical condition that, according to the researchers, could prevent, limit, affect or reduce the subject's completion of a minimum period of 1 + 12 weeks,
• Tissue damage (eczema, etc.) in the area where tDCS will be applied on the skin,
• Patients who are pregnant and do not use/do not want to use contraception during the study period,
• Lactating women,
• Metal implants, fillings in the head or teeth, presence of a medical device in the body (pacemaker, deep brain stimulator, cochlear implant, nerve stimulator, etc.)
• Presence of a skull defect with a radius of 5 mm and/or larger remaining from previous surgeries,
• The patient is participating in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transcranial Direct Stimulation; 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.	Device: Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye); 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.
Sham Comparator: Sham-Transcranial Direct Current Stimulation; 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.	Device: Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Koç University
• Investigators: Principal Investigator: Ezgi Tuna Erdoğan, Assist Prof., Koç University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation (tDCS); drug resistant epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial; Drug Resistant Epilepsy
• Other Study ID Numbers: NM002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No