EpilepsyNCT05248269
Thermocoagulation in Drug Resistant Focal Epilepsy
A study testing Radiofrequency thermocoagulation in people with Epilepsy and Seizures, Focal, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
Trial summary
Therapeutic thermocoagulation will be carried out in patients with drug-resistant focal epilepsy in cases where an epileptogenic zone is found and proven according to stereo-electroencephalography (SEEG) data. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy, Seizures, Focal, Epilepsy Intractable
- What is being tested?
- Radiofrequency thermocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteRussia
- Study dates
- 7 Feb 2022to 1 Dec 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of symptomatic drug-resistant epilepsy according to anamnesis, results of video EEG monitoring with registration of epileptic seizures.
- The epileptogenic zone verified using invasive electrodes.
- The patient has read the information sheet and signed the informed consent form.
- Non-inclusion Criteria:
- Persons with mental disorders.
- Women during pregnancy, childbirth.
Show all 10Show fewer
- Women during breastfeeding.
- Reception of anticoagulants.
- Location of the epileptogenic focus within functionally significant areas, large vessels of the brain.
- Primary generalized forms of epilepsy.
Who cannot join
- Absence of a registered seizure on stereo-EEG.
- Absence of a focal pattern during invasive stereo-EEG monitoring.
- Dropout Criteria:
- Refusal of the patient from observation
- The occurrence of contraindications that may prevent participation in diagnostic and treatment activities.
- Unwillingness or inability of the patient to comply with the requirements of the protocol, including the presence of any condition (physical, mental or social) that may affect his ability to comply with the requirements of the study
- Identification of conditions during the study that meet the exclusion criteria for non-inclusion of patients.
- Lack of effect from thermocoagulation within a month after manipulation or worsening of the condition associated with an increase in the number/severity of epileptic seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Stereo-Electroencephalography Guided Thermocoagulation in Drug Resistant Focal Epilepsy
Therapeutic thermocoagulation will be carried out in patients with drug-resistant focal epilepsy in cases where an epileptogenic zone is found and proven according to stereo-electroencephalography (SEEG) data.
Read the detailed description
Open-label, pilot, non-comparative, interventional cohort study. Each patient will be examined at least 8 times (8 visits will pass): Visit 0 - screening (within 14 days before Visit 1), Visit 1 (visit includes the procedure for the destruction of the epileptogenic focus), Visits 2 and 3 (after 1 and 2 days after Visit 1) - a repeated procedure for the destruction of the epileptogenic focus with an incomplete effect of the first procedure (not mandatory, carried out by the decision of the principal investigator), Visits 4-7 (7, 14, 30, 180 days after the procedure for the destruction of the epileptogenic focus).
Patients will be divided into 4 cohorts of 4 patients. Enrollment in the study of the next cohort of patients will be based on the safety analysis of the previous cohort 1 day after the manipulation.
After assessing the position of the electrodes based on the conjugation of brain MRI data before and after SEEG implantation and seizure recording, the ictal zone is determined. Thus, the localization of pathological activity is determined on the basis of neuroimaging data, as well as in accordance with the activity under certain contacts of the SEEG electrodes.
After explaining the treatment options to the patient and relatives, informed voluntary consent is taken for the implementation of this procedure.
Using a radio frequency generator Cosman RFG-G4, destruction is carried out at the necessary electrode contacts with a power of 3W, exposure time of 180 sec. In case of pain occurrence, the procedure is immediately terminated. After the procedure, the patient continues SEEG monitoring for 3 days.
If additional epileptogenic zones are identified, if necessary, a repeated thermocoagulation is performed (on the 2nd and 3rd days of the study). If there is no need for a second thermocoagulation, then Visits 2 and 3 are not performed. Next, the patient undergoes removal of the electrodes, a control MRI study is performed. Follow-up includes follow-up for 6 months. Visits 4-6 involve phone interviews with patients. During the conversation, the researcher should clarify complaints, general well-being, the presence and frequency of epileptic seizures over the period of time that has passed since the previous visit.
- Conditions
- Epilepsy, Seizures, Focal, Epilepsy Intractable, Epilepsies, Partial
- Being tested
- Radiofrequency thermocoagulation
- Medical subject headings
- Epilepsy, Seizures, Drug Resistant Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency thermocoagulationProcedure or surgery
The 2 pertinent contacts connect to Radiofrequency thermocoagulation lesion-generator equipment (Cosman G4 with Ad-tech electrodes), expressly modified for use with SEEG electrodes. The following parameters will be adopted: current power 3 W within 180 seconds and current intensity (usually approximately 25 mA) variable according to impedance.
| Study group | Role | What they receive |
|---|---|---|
| Thermocoagulation of epileptogenic zone | Experimental | Not described Receives: Procedure: Radiofrequency thermocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe adverse reactions and events rate
Severe adverse reactions and events will be monitored and registered during procedure of thermocoagulation and up to 6 months after procedure
Measured: Up to 6 months after procedure
Seizure freedom or reduction after procedure
The incidence of seizures will be assessed and registered daily by patient in the diary for self-inspection. Records in the diary will be inspected by investigators during follow-up visits.
Measured: Up to 6 months after procedure
Secondary outcomes (4)
Three-level European quality of life five-dimensional questionnaire
There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Patients choice results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describe the health status.
Measured: Up to 6 months after procedure
Pittsburgh Sleep Quality Index (PSQI) Questionnaire
The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire that assesses sleep quality over a 1 month time frame. It consists of 19 individual elements, making up 7 components that give one overall rating. Each item is weighted on a scale from 0 to 3. The overall PSQI score is then calculated by adding the scores of the seven components to give an overall score of 0 to 21, where lower scores mean healthier sleep quality.
Measured: Up to 6 months after procedure
Change of epileptiform activity on electroencephalography (EEG) study
EEG will be registered and reduction of epileptiform activity will be assessed (Beta, Theta, spikes, sharp waves).
Measured: Days 1, 7, 180
Beck Depression Inventory
This is a 21-question test that helps determine the psychological state of a person.
The score for each category is calculated as follows: each item on the scale is scored from 0 to 3 according to the increasing severity of the symptom. The total score ranges from 0 to 63 and decreases as the condition improves.
The questionnaire is handed out to the patient and filled out by him independently.
The results are evaluated depending on the number of points scored:
0-13 - variations considered normal 14-19 - mild depression 20-28 - moderate depression 29-63 - severe depression
Measured: Up to 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start7 Feb 2022
- Primary completion1 Jul 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrey A Zuev, MD, PhD, Principal investigator, Pirogov National Medical Surgical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248269
- Sponsor's protocol ID
- NMSC-01-22
- Status last verified
- Jul 2024
- First submitted
- 4 Feb 2022
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Stereo-Electroencephalography Guided Thermocoagulation in Drug Resistant Focal Epilepsy
- ClinicalTrials.gov ID
- NCT05248269
- Acronym / sponsor ID
- NMSC-01-22
- Conditions
- Epilepsy, Seizures, Focal, Epilepsy Intractable, Epilepsies, Partial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 Feb 2022 (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.
Therapeutic thermocoagulation will be carried out in patients with drug-resistant focal epilepsy in cases where an epileptogenic zone is found and proven according to stereo-electroencephalography (SEEG) data.
Detailed description
Open-label, pilot, non-comparative, interventional cohort study. Each patient will be examined at least 8 times (8 visits will pass): Visit 0 - screening (within 14 days before Visit 1), Visit 1 (visit includes the procedure for the destruction of the epileptogenic focus), Visits 2 and 3 (after 1 and 2 days after Visit 1) - a repeated procedure for the destruction of the epileptogenic focus with an incomplete effect of the first procedure (not mandatory, carried out by the decision of the principal investigator), Visits 4-7 (7, 14, 30, 180 days after the procedure for the destruction of the epileptogenic focus).
Patients will be divided into 4 cohorts of 4 patients. Enrollment in the study of the next cohort of patients will be based on the safety analysis of the previous cohort 1 day after the manipulation.
After assessing the position of the electrodes based on the conjugation of brain MRI data before and after SEEG implantation and seizure recording, the ictal zone is determined. Thus, the localization of pathological activity is determined on the basis of neuroimaging data, as well as in accordance with the activity under certain contacts of the SEEG electrodes.
After explaining the treatment options to the patient and relatives, informed voluntary consent is taken for the implementation of this procedure.
Using a radio frequency generator Cosman RFG-G4, destruction is carried out at the necessary electrode contacts with a power of 3W, exposure time of 180 sec. In case of pain occurrence, the procedure is immediately terminated. After the procedure, the patient continues SEEG monitoring for 3 days.
If additional epileptogenic zones are identified, if necessary, a repeated thermocoagulation is performed (on the 2nd and 3rd days of the study). If there is no need for a second thermocoagulation, then Visits 2 and 3 are not performed. Next, the patient undergoes removal of the electrodes, a control MRI study is performed. Follow-up includes follow-up for 6 months. Visits 4-6 involve phone interviews with patients. During the conversation, the researcher should clarify complaints, general well-being, the presence and frequency of epileptic seizures over the period of time that has passed since the previous visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermocoagulation of epileptogenic zone | Experimental | Procedure: Radiofrequency thermocoagulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Diagnosis of symptomatic drug-resistant epilepsy according to anamnesis, results of video EEG monitoring with registration of epileptic seizures.
- The epileptogenic zone verified using invasive electrodes.
- The patient has read the information sheet and signed the informed consent form.
- Persons with mental disorders.
- Women during pregnancy, childbirth.
Key exclusion criteria (8 listed)
- Absence of a registered seizure on stereo-EEG.
- Absence of a focal pattern during invasive stereo-EEG monitoring.
- Refusal of the patient from observation
- The occurrence of contraindications that may prevent participation in diagnostic and treatment activities.
- Unwillingness or inability of the patient to comply with the requirements of the protocol, including the presence of any condition (physical, mental or social) that may affect his ability to comply with the requirements of the study
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 |
|---|---|---|
| Radiofrequency thermocoagulationThe 2 pertinent contacts connect to Radiofrequency thermocoagulation lesion-generator equipment (Cosman G4 with Ad-tech electrodes), expressly modified for use with SEEG electrodes. The following parameters will be adopted: current power 3 W within 180 seconds and current intensity (usually approximately 25 mA) variable according to impedance. | Procedure or surgery | Thermocoagulation of epileptogenic zone |
Primary outcome
Severe adverse reactions and events rate
Time frame: Up to 6 months after procedure
Severe adverse reactions and events will be monitored and registered during procedure of thermocoagulation and up to 6 months after procedure
Seizure freedom or reduction after procedure
Time frame: Up to 6 months after procedure
The incidence of seizures will be assessed and registered daily by patient in the diary for self-inspection. Records in the diary will be inspected by investigators during follow-up visits.
4 secondary outcomes
Three-level European quality of life five-dimensional questionnaire
Time frame: Up to 6 months after procedure
Pittsburgh Sleep Quality Index (PSQI) Questionnaire
Time frame: Up to 6 months after procedure
Change of epileptiform activity on electroencephalography (EEG) study
Time frame: Days 1, 7, 180
Beck Depression Inventory
Time frame: Up to 6 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Yes
Related trials for Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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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.
Andrey A Zuev, MD, PhD principal investigator
Pirogov National Medical Surgical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency thermocoagulation in people with Epilepsy and Seizures, Focal, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
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 10 inclusion and 8 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 23 Jul 2024. 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 Russia. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe adverse reactions and events rate (time frame: Up to 6 months after procedure). The study lists 2 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 23 Jul 2024.