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

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Transcranial Magnetic Stimulation; Drug-resistant Epilepsy

Treatments: Device: cTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT06832813

KY20252042

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Participant Group

Experimental group

Description:

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.

Treatment:

Device: cTBS