Drug Resistant EpilepsyNCT05951244
Cathodal Transcranial Direct Current Stimulation in Patients With Drug-resistant Focal Epilepsy
A study testing Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye) in people with Drug Resistant Epilepsy, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2023to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Sacit Karamürsel, Professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koc University
Istanbul, Sarıyer, 34450
Candan Gürses, cagurses@kuh.ku.edu.tr
Ezgi Tuna Erdoğan
About this study
Official title: 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.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)
- Keywords
- drug resistant epilepsy, transcranial direct current stimulation (tDCS)
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months follow-up after tDCS
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the 1st week and 12th week of follow-up after tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start3 Apr 2023
- Primary completionOct 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ezgi Tuna Erdoğan, Assist Prof., Principal investigator, Koç University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951244
- Sponsor's protocol ID
- NM002
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cathodal Transcranial Direct Current Stimulation in Patients With Drug-resistant Focal Epilepsy: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05951244
- Acronym / sponsor ID
- NM002
- Conditions
- Drug Resistant Epilepsy
- Keywords
- drug resistant epilepsy, transcranial direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Stimulation | Active comparator | Device: Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)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. |
| Sham-Transcranial Direct Current Stimulation | Sham comparator | Device: Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Sham-Transcranial Direct Current Stimulation, Transcranial Direct Stimulation |
Primary outcome
Changes in epileptic discharge frequency at 1st week after tDCS compared to baseline epileptic discharge frequency
Time frame: At the 1st week of follow-up after tDCS
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.
Changes in epileptic discharge frequency at 12th week after tDCS compared to baseline epileptic discharge frequency
Time frame: At the 12th week of follow-up after tDCS
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.
Changes in epileptic seizure frequency at 12th week after tDCS compared to baseline (before the tDCS)
Time frame: 3 months follow-up after 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.
4 secondary outcomes
Quality of Life in Epilepsy Inventory (QOLIE-31)
Time frame: At the 1st week and 12th week of follow-up after tDCS
Depression Anxiety and Stress Scale 21 (DASS-21)
Time frame: At the 1st week and 12th week of follow-up after tDCS
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At the 1st week and 12th week of follow-up after tDCS
Epworth Sleepiness Scale
Time frame: At the 1st week and 12th week of follow-up after tDCS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sacit Karamürsel, Professor contact
Ezgi Tuna Erdoğan, Assist Prof. principal investigator
Koç University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye) in people with Drug Resistant Epilepsy, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ezgi Tuna Erdoğan, Assist Prof. (+90 533 643 4749, ezerdogan@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in epileptic discharge frequency at 1st week after tDCS compared to baseline epileptic discharge frequency (time frame: At the 1st week of follow-up after tDCS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.