Transcranial Magnetic StimulationNCT05809349
The Mechanism of cTBS Targeting Dentate Nucleus for DRE
A study testing transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation and Drug Resistant Epilepsy, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Magnetic Stimulation, Drug Resistant Epilepsy, Cerebellum
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- transcranial magnetic stimulation
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DRE patients | Experimental | There will be 50 drug-refractory epilepsy (DRE) patients in this study. Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Apr 2023
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809349
- Sponsor's protocol ID
- KY20232104
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05809349
- Acronym / sponsor ID
- KY20232104
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRE patients | Experimental | Device: transcranial magnetic stimulationThere will be 50 drug-refractory epilepsy (DRE) patients in this study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulationThe 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. | Device | DRE patients |
Primary outcome
TMS evoked potential amplitude change between pre- and post- treatment
Time frame: 8 weeks
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
Time frame: 2 weeks
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
Time frame: 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation and Drug Resistant Epilepsy, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMS evoked potential amplitude change between pre- and post- treatment (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.