Thermocoagulation in Drug Resistant Focal Epilepsy

NCT05248269 | Active Not Recruiting

• 1 other identifier: NMSC-01-22
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy; Seizures, Focal; Epilepsy Intractable; Epilepsies, Partial

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Up to 6 months after procedure

Secondary Outcomes (4)

• Three-level European quality of life five-dimensional questionnaire

  Up to 6 months after procedure

• Pittsburgh Sleep Quality Index (PSQI) Questionnaire

  Up to 6 months after procedure

• Change of epileptiform activity on electroencephalography (EEG) study

  Days 1, 7, 180

• Beck Depression Inventory

  Up to 6 months after procedure

Study Arms (1)

Thermocoagulation of epileptogenic zone

EXPERIMENTAL

Procedure: Radiofrequency thermocoagulation

Interventions

Radiofrequency thermocoagulation PROCEDURE

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.

Thermocoagulation of epileptogenic zone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia: lead

Study Sites (1)

Pirogov National Medical and Surgical Center

Moscow, 105064, Russia

Location

MeSH Terms

Conditions

Epilepsy; Seizures; Drug Resistant Epilepsy; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrey A Zuev, MD, PhD

  Pirogov National Medical and Surgical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 21, 2022
• Study Start: February 7, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 months after completion of the study
• Access Criteria: upon the request

Locations

RU (1)