The Mechanism of cTBS Targeting Dentate Nucleus for DRE

Not Applicable

Completed

• Conditions: Cerebellum; Transcranial Magnetic Stimulation; Drug Resistant Epilepsy
• Interventions: Device: transcranial magnetic stimulation

• Registration Number: NCT05809349
• Lead Sponsor: Xijing Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Study Start: 2023-04-01
• Study First Posted: 2023-04-12
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Participants aged between 18 and 60,
2. Participants who are in line with the diagnostic criteria for epilepsy and drug-refractory epilepsy (DRE),
3. Participants who have duration of epilepsy ≥ 2 years and seizure frequency ≥ 2 seizures per month,
4. The type and dosage of anti-seizure medications (ASMs) keep unchanged during the experiment,
5. Participants and their families are aware of this study and sign informed consent.

Exclusion Criteria

1. Participants who are unable to cooperate with treatment and examinations,
2. Participants who are in status epilepticus (SE),
3. Participants who are complicated with a serious infection, cerebrovascular disease, malignant tumour, and other nervous system diseases, with serious dysfunction of heart, liver, kidney, and other organs, and with psychiatric disorders,
4. Participants who are pregnant or breastfeeding,
5. Participants have contraindications of TMS and MRI, that is, the presence of metal or implanted devices in the body, such as cardiac pacemaker, deep brain stimulator, etc,
6. Participants who are in other clinical trials,
7. Participants who withdraw informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DRE patients	transcranial magnetic stimulation	There will be 50 drug-refractory epilepsy (DRE) patients in this study.

Primary Outcome Measures

Name	Time	Method
TMS evoked potential amplitude change between pre- and post- treatment	8 weeks	TMS-EEG will be recorded pre- and post- treatment by physician and the electroencephalogram (EEG) data will be analyzed with TMS evoked potential by technician, finally, the amplitude change between pre- and post- treatment will be obtained.
functional magnetic resonance images brain functional connection change between pre- and post- treatment	2 weeks	Functional magnetic resonance images (fMRI) will be recorded pre- and post- treatment within 24h. Brain functional connection will be analyzed through fMRI by technician and the change of brain functional connection will be obtained.
diffusion tensor imaging fiber connectivity change between pre- and post- treatment	12 weeks	Diffusion tensor imaging (DTI) will be recorded pre-treatment and post-treatment in three months. DTI data will be analyzed by technician and the change of fiber connectivity change will be obtained.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China