The Mechanism of cTBS Targeting Dentate Nucleus for DRE

Transcranial Magnetic Stimulation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05809349
• Other study ID #: KY20232104
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebellum
• Drug Resistant Epilepsy
• Epilepsy
• Transcranial Magnetic Stimulation

Intervention

Device:
• transcranial magnetic stimulation
The stimulation intensity will be 80% resting motor threshold (RMT). The theta burst stimulation (cTBS) with a frequency at 50Hz, repeated at 5Hz, are delivered in a duration of 33.2s with the number of stimulation pulses of 600. Two groups of stimulation will be repeated in each cerebellar dentate nucleus with an interval of 5 min in each group. The treatment will last for 2 weeks, with 5 times per week.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TMS evoked potential amplitude change between pre- and post- treatment	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.	8 weeks
Primary	functional magnetic resonance images brain functional connection change between pre- and post- treatment	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.	2 weeks
Primary	diffusion tensor imaging fiber connectivity change between pre- and post- treatment	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.	12 weeks