Assessment of Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation (cTBS) Effects in Generalized Epilepsy Patients. (TBS-GEM)

Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu

Status: Completed

Conditions: Generalized Epilepsy

Treatments: Device: Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06797791

19062018-85

Details and patient eligibility

About

The goal of this clinical study is to assess the efficacy of multifocal theta burst transcranial magnetic stimulation in the prevention of epileptic seizures in adult patients with generalized epilepsy. The main questions it aims to answer are:

• How does multifocal continuous theta burst stimulation (cTBS) impact the frequency and severity of epileptic seizures?
• Does cTBS influence the quality of life in patients with generalized epilepsy?
• What is the safety and tolerability profile of the experimental multifocal cTBS protocol?

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with generalized epilepsy (according to ILAE 2017 classification of epilepsy).

Exclusion criteria

• refusal to sign the informed consent;
• focal, combined or unknown epilepsy (according to ILAE criteria);
• drug-resistant form of epilepsy (according to ILAE definition);
• history or symptoms of renal or hepatic failure;
• history of oncological disorder;
• uncontrolled high blood pressure;
• cognitive impairment;
• psychiatric disorders;
• signs of structural brain injury or focal neurological symptoms;
• use of opioids or muscle relaxants;
• history of substance abuse;
• ferromagnetic implants in head and neck regions;
• cardiac pacemakers;
• pregnancy or lactation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

14 participants in 1 patient group

Multifocal continuous theta burst transcranial magnetic stimulation

Experimental group

Description:

After determining the resting motor threshold (RMT), all subjects underwent 6 sessions of continuous theta burst stimulation (cTBS) for 6 consecutive days according to the research protocol. TBS sessions were accompanied by parallel high-density electroencephalography (hdEEG) monitoring. Afterward, a follow-up period of up to three months with visits at predefined intervals of 4, 8, and 12 weeks was carried out.

Treatment:

Device: Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation