Clinical trial NCT05809349: The Mechanism of cTBS Targeting Dentate Nucleus for DRE
Official title: The Mechanism of Theta Burst Stimulation (cTBS) in the Treatment of Drug-refractory Epilepsy Targeting the Dentate Nucleus of Cerebellum: An Exploratory Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Drug Resistant Epilepsy
Cerebellum
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: TMS evoked potential amplitude change between pre- and post- treatment
timeFrame: 8 weeks
measure: functional magnetic resonance images brain functional connection change between pre- and post- treatment
timeFrame: 2 weeks
measure: diffusion tensor imaging fiber connectivity change between pre- and post- treatment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References: