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

NCT05951244 | Unknown

• 1 other identifier: NM002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

drug resistant epilepsy; transcranial direct current stimulation (tDCS)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Quality of Life in Epilepsy Inventory (QOLIE-31)

  At the 1st week and 12th week of follow-up after tDCS

• Depression Anxiety and Stress Scale 21 (DASS-21)

  At the 1st week and 12th week of follow-up after tDCS

• Pittsburgh Sleep Quality Index (PSQI)

  At the 1st week and 12th week of follow-up after tDCS

• Epworth Sleepiness Scale

  At the 1st week and 12th week of follow-up after tDCS

Study Arms (2)

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.

Device: Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)

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.

Device: Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)

Interventions

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.

Sham-Transcranial Direct Current Stimulation; Transcranial Direct Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Sarıyer, 34450, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ezgi Tuna Erdoğan, Assist Prof.

  Koç University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ezgi Tuna Erdoğan, Assist Prof.

CONTACT

+90 533 643 4749; ezerdogan@ku.edu.tr

Sacit Karamürsel, Professor

CONTACT

skaramursel@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: July 19, 2023
• Study Start: April 3, 2023
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-04

Locations

TU (1)