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Completed

NCT Number: NCT06797791

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

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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Key information

Conditions

Generalized Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Medicine Institute, Chisinau, Moldova

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation

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.

Other names: cTBS

Primary outcomes

  1. Seizure frequency

    Time frame: at 12 weeks

    ≥50% improvement from Baseline in seizure frequency

Secondary outcomes

  1. Quality of Life in Epilepsy (QOLIE-31) Inventory

    Time frame: at 12 weeks

    Exploratory analyses will investigate the changes in the 31-item Quality of Life in Epilepsy (QOLIE-31) score from Baseline due to study protocol and interventions. The questionnaire comprises seven categories: worry about epileptic seizures, emotional well-being, energy/fatigue, social function, cognitive function, medication effects, and general quality of life. The scale is scored from 0 to 100. Higher scores reflect a higher quality of life.

  2. Seizure Severity Questionnaire (SSQ)

    Time frame: at 12 weeks

    Exploratory analyses will investigate the changes in the Seizure Severity Questionnaire (SSQ) score from Baseline due to study protocol and intervention. The SSQ is a 24-item questionnaire that includes questions regarding the frequency and usefulness of warning signs, severity and disturbance of ictal movements, loss of consciousness, and frequency, severity, and postictal cognitive, emotional, and physical disturbance. Scores per category range from 1 to 7, with higher scores indicating greater severity.

  3. Patient Global Impression of Change (PGIC)

    Time frame: at 12 weeks

    Improvement in Patient Global Impression of Change (PGIC) score from Baseline. PGIC is used to assess patients' perceptions of changes after treatment. It is a 7-point scale with the options "very much improved", "much improved", "minimally improved", "no change", "minimally worsened", "much worsened" and "very much worsened".

Other outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: From start of intervention (Day 1) through 6 consecutive days (Day 6) of treatment

    After each continuous Theta Burst Stimulation (cTBS) session an assessment of possible adverse events ( CTCAE v4.0 terms) occurring during and/or immediately after stimulation was done.

Sponsors and collaborators

Lead sponsor

Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu

Other

Collaborators

  • Johannes Gutenberg University Mainz

Registry information

Official study title

Multifocal Theta Burst Transcranial Magnetic Stimulation in Generalized Epilepsy Management.

Acronym: TBS-GEM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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