The Mechanism of cTBS Targeting Dentate Nucleus for DRE

NCT05809349 | Completed

• 1 other identifier: KY20232104
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcranial Magnetic Stimulation; Drug Resistant Epilepsy; Cerebellum

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

DRE patients

EXPERIMENTAL

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

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

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.

DRE patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Participants who are unable to cooperate with treatment and examinations,
• Participants who are in status epilepticus (SE),
• 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 who are pregnant or breastfeeding,
• 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,
• Participants who are in other clinical trials,
• Participants who withdraw informed consent.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 12, 2023
• Study Start: April 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 23, 2024

Record last verified: 2023-03

Locations

CN (1)