NCT05809349Completed
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
Source: ClinicalTrials.gov · Last updated 23 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 29 Mar 2023
- Start date
- 1 Apr 2023
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Xijing Hospital
- Diseases
- Epilepsy
- NCT number
- NCT05809349
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 1 Apr 2023 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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,
- 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,
Other
- Participants who are unable to cooperate with treatment and examinations,
- Participants who are in status epilepticus (SE),
- Participants who are pregnant or breastfeeding,
- Participants who are in other clinical trials,
- Participants who withdraw informed consent.
Who the study is looking for
- Participants aged between 18 and 60,
- Participants who are in line with the diagnostic criteria for epilepsy and drug-refractory epilepsy (DRE),
- Participants who have duration of epilepsy ≥ 2 years and seizure frequency ≥ 2 seizures per month,
- The type and dosage of anti-seizure medications (ASMs) keep unchanged during the experiment,
- Participants and their families are aware of this study and sign informed consent.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.