Trials / Completed
CompletedNCT05809349
The Mechanism of cTBS Targeting Dentate Nucleus for DRE
The Mechanism of Theta Burst Stimulation (cTBS) in the Treatment of Drug-refractory Epilepsy Targeting the Dentate Nucleus of Cerebellum: An Exploratory Clinical Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Xijing Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
In our previous cross-over study--the continuous θ burst stimulation (cTBS) targeting cerebellum dentate nucleus of 44 drug-refractory epilepsy (DRE) patients, a significant reduction in seizure frequency was observed. However, the mechanism of this target to reduce seizures is still unknown. This study aims to explore the mechanism of cTBS targeting cerebellum dentate nucleus for DRE, in order to provide theoretical support for this treatment method. A total of 50 patients with DRE will have 2-week cTBS treatment via accurate navigation to bilateral cerebellar dentate nucleus. Participants will be took TMS-EEG, functional magnetic resonance imaging, and diffusion tensor imaging (DTI) pre- and post- treatment. These three examinations will help to analyze the brain functional connectivity and suggest the mechanism of action of this treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | transcranial magnetic stimulation | The stimulation intensity will be 80% resting motor threshold (RMT). The theta burst stimulation (cTBS) with a frequency at 50Hz, repeated at 5Hz, are delivered in a duration of 33.2s with the number of stimulation pulses of 600. Two groups of stimulation will be repeated in each cerebellar dentate nucleus with an interval of 5 min in each group. The treatment will last for 2 weeks, with 5 times per week. |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2023-11-30
- Completion
- 2023-12-31
- First posted
- 2023-04-12
- Last updated
- 2024-04-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05809349. Inclusion in this directory is not an endorsement.