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

Primary Purpose

Drug Resistant Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)
Sponsored by
Koç University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Resistant Epilepsy focused on measuring drug resistant epilepsy, transcranial direct current stimulation (tDCS)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Koc UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Transcranial Direct Stimulation

Sham-Transcranial Direct Current Stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 30, 2023
Last Updated
July 10, 2023
Sponsor
Koç University
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1. Study Identification

Unique Protocol Identification Number
NCT05951244
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koç University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Resistant Epilepsy
Keywords
drug resistant epilepsy, transcranial direct current stimulation (tDCS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham-Transcranial Direct Current Stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation-TessaNova (Teknofil-Turkiye)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in epileptic discharge frequency at 1st week after tDCS compared to baseline epileptic discharge frequency
Description
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.
Time Frame
At the 1st week of follow-up after tDCS
Title
Changes in epileptic discharge frequency at 12th week after tDCS compared to baseline epileptic discharge frequency
Description
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.
Time Frame
At the 12th week of follow-up after tDCS
Title
Changes in epileptic seizure frequency at 12th week after tDCS compared to baseline (before the tDCS)
Description
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.
Time Frame
3 months follow-up after tDCS
Secondary Outcome Measure Information:
Title
Quality of Life in Epilepsy Inventory (QOLIE-31)
Description
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.
Time Frame
At the 1st week and 12th week of follow-up after tDCS
Title
Depression Anxiety and Stress Scale 21 (DASS-21)
Description
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.
Time Frame
At the 1st week and 12th week of follow-up after tDCS
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
At the 1st week and 12th week of follow-up after tDCS
Title
Epworth Sleepiness Scale
Description
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.
Time Frame
At the 1st week and 12th week of follow-up after tDCS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ezgi Tuna Erdoğan, Assist Prof.
Phone
+90 533 643 4749
Email
ezerdogan@ku.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Sacit Karamürsel, Professor
Email
skaramursel@ku.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ezgi Tuna Erdoğan, Assist Prof.
Organizational Affiliation
Koç University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koc University
City
Istanbul
State/Province
Sarıyer
ZIP/Postal Code
34450
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candan Gürses
Email
cagurses@kuh.ku.edu.tr
First Name & Middle Initial & Last Name & Degree
Ezgi Tuna Erdoğan
First Name & Middle Initial & Last Name & Degree
Candan Gürses
First Name & Middle Initial & Last Name & Degree
Sacit Karamürsel

12. IPD Sharing Statement

Learn more about this trial

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

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