Long Term Efficacy and Safety of TMS Targeting Cerebellum to Treat DRE

ConditionsDrug-resistant Epilepsy Transcranial Magnetic Stimulation

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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. 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.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Participant GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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