An interventional study of Multifocal Continuous Theta Burst Transcranial Magnetic Stimulation in Generalized Epilepsy, sponsored by Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu. Completed at 2 sites in Moldova, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu · Not applicable, Interventional, and Treatment
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:
39 studies on the registry are indexed under Epilepsy, Generalized; 4 are open to participants now.
This study's enrollment of 14 is below the median of 75 across 25 interventional studies indexed under Epilepsy, Generalized.
Browse Epilepsy, Generalized studies →This is the only study on the registry with Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
Also known as: cTBS
Seizure frequency
≥50% improvement from Baseline in seizure frequency
Time frame: at 12 weeks
Quality of Life in Epilepsy (QOLIE-31) Inventory
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.
Time frame: at 12 weeks
Seizure Severity Questionnaire (SSQ)
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.
Time frame: at 12 weeks
Patient Global Impression of Change (PGIC)
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".
Time frame: at 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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.
Time frame: From start of intervention (Day 1) through 6 consecutive days (Day 6) of treatment
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Aug 2023, 20 months.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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