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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-09-30

Brief Summary

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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?

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Detailed Description

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Conditions

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Generalized Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multifocal continuous theta burst transcranial magnetic stimulation

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.

Group Type EXPERIMENTAL

Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation

Intervention Type DEVICE

The experimental stimulation protocol included 3 trains of cTBS with an inter-train interval of 10 min. Each train of cTBS consisted of 600 pulses applied in blocks at the theta frequency (200ms) with a duration of 40 s. A block of pulses consisted of 3 pulses at 50Hz frequency, stimulus intensity being estimated as 80% of the RMT. Stimulation application was performed by positioning the Magventure MMC-140 coil over the vertex (Cz) according to the 10-20 EEG system overlapping bilateral motor and somatosensory cortical areas.

Interventions

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Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation

The experimental stimulation protocol included 3 trains of cTBS with an inter-train interval of 10 min. Each train of cTBS consisted of 600 pulses applied in blocks at the theta frequency (200ms) with a duration of 40 s. A block of pulses consisted of 3 pulses at 50Hz frequency, stimulus intensity being estimated as 80% of the RMT. Stimulation application was performed by positioning the Magventure MMC-140 coil over the vertex (Cz) according to the 10-20 EEG system overlapping bilateral motor and somatosensory cortical areas.

Intervention Type DEVICE

Other Intervention Names

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cTBS

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No