NCT05042726

cTBS Targeting Cerebellum for Drug-refractory Epilepsy

Bilateral Continuous Theta Burst Stimulation of Cerebellum for Drug-refractory Epilepsy: A Double Blind, Randomised, Single Centre, Crossover Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to observe the effect and safety of cerebellar continuous θ burst stimulation (cTBS) for drug-refractory epilepsy(DRE), in order to provide a new treatment for DRE and improve the quality of life of those patients. A total of 44 patients with DRE will have cTBS via accurate navigation to bilateral cerebellar dentate nuclei. Patients will be randomised into 2 groups in a crossover trial design to have 2 week periods of cTBS separated by 8 week washout periods, following which the patient will cross over to have the opposite condition for a further 2 week. Frequency and symptoms of seizures, scalp EEG, clinical scores, and QOLIE-31 were assessed at baseline and after 1 and 2 month of treatment.

Conditions

• Drug Refractory Epilepsy

Interventions

Type	Name	Description
DEVICE	cTBS First	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 33.2s, 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	Pseudo-stimulation First	The transcranial magnetic stimulator operating system has a built-in control group option, in which the stimulation parameters are set consistent with the research group, which can realize the operation of only sound without stimulation.

Timeline

• Start date: 2021-08-02
• Primary completion: 2022-08-24
• Completion: 2022-08-26
• First posted: 2021-09-13
• Last updated: 2023-01-05

Locations

1 site across 1 country: China