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Not yet recruiting NCT06832813

Long Term Efficacy and Safety of TMS Targeting Cerebellum to Treat DRE

No phase Interventional Drug-resistant Epilepsy Transcranial Magnetic Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cTBS.
Who it may be relevant to
Registry conditions: Drug-resistant Epilepsy, Transcranial Magnetic Stimulation. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Long Term Efficacy and Safety of Transcranial Magnetic Stimulation Targeting Cerebellum to Treat Drug-resistant Epilepsy During Enhanced and Maintenance Phase

Overview

This study aims to observe the long term efficacy and safety of cerebellar continuous θ burst stimulation (cTBS) for drug-resistant Epilepsy during enhanced and maintenance phase，in order to provide a new treatment for long-term control of drug-resistant epilepsy and improve the quality of life of those patients. A total of 100 patients with DRE will undergo cTBS treatment by precise navigation to bilateral cerebellar dentate nuclei. The frequency and clinical feature of seizures, scalp EEG，clinical score, MOCA，MMSE，and QOLIE-31 were ssessed at baseline, after 2 weeks of enhanced phase，8 weeks of consolidate phase, and 8 weeks of maintenance phase.

Interventions

  • Device cTBS
    Continuous θ-burst stimulation (cTBS) is characterized by plexus stimulation. The stimulation intensity was 80% resting motor threshold (RMT) at 50Hz of intra plexus pulse while the frequency of inter plexus pulse is 5Hz, the duration was 40s, and the number of stimulation pulses was 600. Two groups of stimulation were repeated in each cerebellar dentate nucleus with an interval of 5 min in each group. 1. Enhanced phase：participants received cTBS treatment for a total of 5 times a week for 2 we

Primary outcome measures

  • seizure reduction rate [Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks]
  • responder rate [Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks]
Secondary outcome measures (5)
  • QOLIE-31 scale scores [Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks]
  • scalp electroencephalogram [Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks]
  • MRI [Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks]
  • MoCA [Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks]
  • MMSE [Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks]

Eligibility criteria

Inclusion criteria

  • Age 18-65 years old，
  • Participants who are diagnosed as drug- resistant epilepsy,
  • Participants who has a history of DRE ≥2 years before enrollment，
  • Participants who has a seizure frequency of ≥2 seizures every month within 3 months before enrollment,
  • Participants and their families are aware of this study and sign informed consent.

Exclusion criteria

  • Participants who are in status epilepticus,
  • Participants who are complicated with serious infection, cerebrovascular disease, malignant tumor and other nervous system diseases, with serious dysfunction of heart, liver, kidney and other organs, and with psychiatric disorders,
  • Participants plan invasive therapy, such as operation,
  • Participants who are in pregnancy or lactating,
  • Patients cannot tolerate repeated transcranial magnetic stimulation, or have contraindications of repeated transcranial magnetic stimulation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Xijing Hospital — Xi'an

Identifiers

NCT: NCT06832813 · KY20252042

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗