Clinical trial NCT06832813: Long Term Efficacy and Safety of TMS Targeting Cerebellum to Treat DRE
Official title: Long Term Efficacy and Safety of Transcranial Magnetic Stimulation Targeting Cerebellum to Treat Drug-resistant Epilepsy During Enhanced and Maintenance Phase
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Drug-resistant Epilepsy
Transcranial Magnetic Stimulation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: seizure reduction rate
timeFrame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
measure: responder rate
timeFrame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
Secondary outcomes:
measure: QOLIE-31 scale scores
timeFrame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
measure: scalp electroencephalogram
timeFrame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
measure: MRI
timeFrame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
measure: MoCA
timeFrame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
measure: MMSE
timeFrame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References: