Back to resultsThe Mechanism of cTBS Targeting Dentate Nucleus for DRE
Primary Purpose
Transcranial Magnetic Stimulation, Drug Resistant Epilepsy, Cerebellum
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional other trial for Transcranial Magnetic Stimulation
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DRE patients
Arm Description
There will be 50 drug-refractory epilepsy (DRE) patients in this study.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05809349
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Magnetic Stimulation, Drug Resistant Epilepsy, Cerebellum
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DRE patients
Arm Type
Experimental
Arm Description
There will be 50 drug-refractory epilepsy (DRE) patients in this study.
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
TMS evoked potential amplitude change between pre- and post- treatment
Description
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.
Time Frame
8 weeks
Title
functional magnetic resonance images brain functional connection change between pre- and post- treatment
Description
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.
Time Frame
2 weeks
Title
diffusion tensor imaging fiber connectivity change between pre- and post- treatment
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Wen, Prof
Phone
+86-029-84773664
Email
jiangwen@fmmu.edu.cn
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Wen, Prof
Phone
+86-029-84773664
Email
jiangwen@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
The Mechanism of cTBS Targeting Dentate Nucleus for DRE
We'll reach out to this number within 24 hrs