The Mechanism of cTBS Targeting Dentate Nucleus for DRE

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Drug Resistant Epilepsy; Cerebellum; Transcranial Magnetic Stimulation

Treatments: Device: transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05809349

KY20232104

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

DRE patients

Experimental group

Description:

There will be 50 drug-refractory epilepsy (DRE) patients in this study.

Treatment:

Device: transcranial magnetic stimulation