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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cTBS | Device | 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.
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| Measure | Description | Time Frame |
|---|---|---|
| seizure reduction rate | 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 | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks |
| responder rate | 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 | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| QOLIE-31 scale scores | Quality of Life in Epilepsy-31. Scores range from 0 to 100, with higher scores indicating better quality of life. | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks |
| scalp electroencephalogram |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
Routine scalp electroencephalogram at 40 min |
| Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks |
| MRI | Diffusion tensor imaging，Functional MRI | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks |
| MoCA | Montreal Cognitive Assessment. A max score is 30 points, and a score ≥ 26 is considered normal. | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks |
| MMSE | Mini-Mental State Examination. The normal values are defined as: illiterates >17, primary school >20, junior high school or above >24. | Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks |