An interventional study of cTBS in Drug-resistant Epilepsy and Transcranial Magnetic Stimulation, sponsored by Xijing Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.
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Exclusion Criteria:
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.
Device: cTBS
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.
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
Time frame: 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
Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
QOLIE-31 scale scores
Quality of Life in Epilepsy-31. Scores range from 0 to 100, with higher scores indicating better quality of life.
Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
scalp electroencephalogram
Routine scalp electroencephalogram at 40 min
Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
MRI
Diffusion tensor imaging，Functional MRI
Time frame: 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.
Time frame: 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.
Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
Plan to share: No
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Xijing Hospital