Long Term Efficacy and Safety of TMS Targeting Cerebellum to Treat DRE
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXijing Hospital
About this trial
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
Qualifiers
Age 18-65 years old，
Participants who are diagnosed as drug- resistant epilepsy,
Participants who has a history of DRE ≥2 years before enrollment，
Participants who has a seizure frequency of ≥2 seizures every month within 3 months before enrollment,
Disqualifiers
Participants who are in status epilepticus,
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,
Participants plan invasive therapy, such as operation,
Participants who are in pregnancy or lactating,
Trial design
Treatments tested in this trial
- cTBS
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov