Generalized Epilepsy
Conditions
Keywords
TBS, cTBS, IGE, Generalized, Epilepsy, Theta, Burst, Transcranial, Magnetic, Stimulation, Continuous
Brief summary
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?
Interventions
DEVICEMultifocal 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.
Sponsors
Johannes Gutenberg University Mainz
Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure frequency | at 12 weeks | ≥50% improvement from Baseline in seizure frequency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in Epilepsy (QOLIE-31) Inventory | 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. |
| Seizure Severity Questionnaire (SSQ) | 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. |
| Patient Global Impression of Change (PGIC) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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. |
Countries
Moldova
Outcome results
None listed