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| Name | Class |
|---|---|
| Johannes Gutenberg University Mainz | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifocal continuous theta burst transcranial magnetic stimulation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure frequency | ≥50% improvement from Baseline in seizure frequency | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of intervention (Day 1) through 6 consecutive days (Day 6) of treatment |
Inclusion Criteria:
- Adult patients with generalized epilepsy (according to ILAE 2017 classification of epilepsy).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Medicine Institute | Chisinau | MD2004 | Moldova | |||
| Nicolae Testemițanu State University of Medicine and Pharmacy |
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| 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. | 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". | at 12 weeks |
| Chisinau |
| MD2004 |
| Moldova |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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