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The Mechanism of cTBS Targeting Dentate Nucleus for DRE | Clinical Trials | Clareo Health

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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

NCT05809349•Xijing Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Xijing Hospital

Xi'an, Shaanxi, China

Key Dates

Start Date

April 1, 2023

Primary Completion Date

November 30, 2023

Completion Date

December 31, 2023

Last Updated

April 23, 2024

Enrollment

ACTUAL participants

Conditions

Transcranial Magnetic StimulationDrug Resistant EpilepsyCerebellum

Interventions

transcranial magnetic stimulation

DEVICE

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Mechanism of cTBS Targeting Dentate Nucleus for DRE

Inclusion Criteria

Exclusion Criteria

Examining Lateralized Aspects of Motor Control Using Non-invasive Neural Stimulation

Repetitive Transcranial Magnetic Stimulation Combined With Language Training for Language Disorders in Children With Global Developmental Delay

Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain

Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait

The Myelin Disorders Biorepository Project

The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy