Drug-resistant Epilepsy, Transcranial Magnetic Stimulation
Conditions
Brief summary
This study aims to observe the long term efficacy and safety of cerebellar continuous θ burst stimulation (cTBS) for drug-resistant Epilepsy during enhanced and maintenance phase，in order to provide a new treatment for long-term control of drug-resistant epilepsy and improve the quality of life of those patients. A total of 100 patients with DRE will undergo cTBS treatment by precise navigation to bilateral cerebellar dentate nuclei. The frequency and clinical feature of seizures, scalp EEG，clinical score, MOCA，MMSE，and QOLIE-31 were ssessed at baseline, after 2 weeks of enhanced phase，8 weeks of consolidate phase, and 8 weeks of maintenance phase.
Interventions
DEVICEcTBS
Continuous θ-burst stimulation (cTBS) is characterized by plexus stimulation. The stimulation intensity was 80% resting motor threshold (RMT) at 50Hz of intra plexus pulse while the frequency of inter plexus pulse is 5Hz, the duration was 40s, and the number of stimulation pulses was 600. Two groups of stimulation were repeated in each cerebellar dentate nucleus with an interval of 5 min in each group. 1. Enhanced phase：participants received cTBS treatment for a total of 5 times a week for 2 weeks； 2. Consolidation phase：participants received cTBS treatment for a total of twice a week (at least 24 hours apart) for 8 weeks； 3. Maintenance phase：participants received cTBS treatment for a total of once a week for 8 weeks.
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years old， 2. Participants who are diagnosed as drug- resistant epilepsy, 3. Participants who has a history of DRE ≥2 years before enrollment， 4. Participants who has a seizure frequency of ≥2 seizures every month within 3 months before enrollment, 5. Participants and their families are aware of this study and sign informed consent.
Exclusion criteria
1. Participants who are in status epilepticus, 2. Participants who are complicated with serious infection, cerebrovascular disease, malignant tumor and other nervous system diseases, with serious dysfunction of heart, liver, kidney and other organs, and with psychiatric disorders, 3. Participants plan invasive therapy, such as operation, 4. Participants who are in pregnancy or lactating, 5. Patients cannot tolerate repeated transcranial magnetic stimulation, or have contraindications of repeated transcranial magnetic stimulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| seizure reduction rate | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks | A 28-day baseline for seizure frequency will be recorded by the patients themselves or their guardian before therapy and then compare to the frequency after enhanced phase /consolidation/maintenance treatment / 8 weeks after the end of all treatment |
| responder rate | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks | proportion of people with a 50% or greater reduction in seizure frequency following enhanced phase /consolidation/maintenance treatment / 8 weeks after the end of all treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks | Diffusion tensor imaging，Functional MRI |
| QOLIE-31 scale scores | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks | Quality of Life in Epilepsy-31. Scores range from 0 to 100, with higher scores indicating better quality of life. |
| MMSE | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks | Mini-Mental State Examination. The normal values are defined as: illiterates \>17, primary school \>20, junior high school or above \>24. |
| MoCA | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks | Montreal Cognitive Assessment. A max score is 30 points, and a score ≥ 26 is considered normal. |
| scalp electroencephalogram | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks | Routine scalp electroencephalogram at 40 min |
Countries
China
Outcome results
None listed