Clinical trial NCT05951244: Cathodal Transcranial Direct Current Stimulation in Patients With Drug-resistant Focal Epilepsy
Official title: Cathodal Transcranial Direct Current Stimulation in Patients With Drug-resistant Focal Epilepsy: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug Resistant Epilepsy
Keywords: drug resistant epilepsy
transcranial direct current stimulation (tDCS)
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in epileptic discharge frequency at 1st week after tDCS compared to baseline epileptic discharge frequency
timeFrame: At the 1st week of follow-up after tDCS
measure: Changes in epileptic discharge frequency at 12th week after tDCS compared to baseline epileptic discharge frequency
timeFrame: At the 12th week of follow-up after tDCS
measure: Changes in epileptic seizure frequency at 12th week after tDCS compared to baseline (before the tDCS)
timeFrame: 3 months follow-up after tDCS
Secondary outcomes:
measure: Quality of Life in Epilepsy Inventory (QOLIE-31)
timeFrame: At the 1st week and 12th week of follow-up after tDCS
measure: Depression Anxiety and Stress Scale 21 (DASS-21)
timeFrame: At the 1st week and 12th week of follow-up after tDCS
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At the 1st week and 12th week of follow-up after tDCS
measure: Epworth Sleepiness Scale
timeFrame: At the 1st week and 12th week of follow-up after tDCS
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
state: Sarıyer
Study officials:
affiliation: Koç University School of Medicine
name: Ezgi Tuna Erdoğan, Assist Prof.
role: PRINCIPAL_INVESTIGATOR
References: