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

NCT ID: NCT05951244

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2025-04-30

Brief Summary

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.

Conditions

Drug Resistant Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Koç University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ezgi Tuna Erdoğan, Assist Prof.

Role: PRINCIPAL_INVESTIGATOR

Koç University School of Medicine

Locations

Koc University

Istanbul, Sarıyer, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ezgi Tuna Erdoğan, Assist Prof.

Role: CONTACT

ezerdogan@ku.edu.tr

+90 533 643 4749

Sacit Karamürsel, Professor

Role: CONTACT

skaramursel@ku.edu.tr

Facility Contacts

Candan Gürses

Role: primary

cagurses@kuh.ku.edu.tr

Other Identifiers

NM002

Identifier Type: -

Identifier Source: org_study_id