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NCT Number: NCT06832813

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

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.

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Key information

Conditions

Drug-resistant Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases Transcranial Magnetic Stimulation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cTBS

Device

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.

  • Enhanced phase：participants received cTBS treatment for a total of 5 times a week for 2 weeks；
  • Consolidation phase：participants received cTBS treatment for a total of twice a week (at least 24 hours apart) for 8 weeks；
  • Maintenance phase：participants received cTBS treatment for a total of once a week for 8 weeks.

Primary outcomes

  1. seizure reduction rate

    Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks

    A 28-day baseline for seizure frequency will be recorded by the patients themselves or their guardian before therapy and then compare to the frequency after enhanced phase /consolidation/maintenance treatment / 8 weeks after the end of all treatment

  2. responder rate

    Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks

    proportion of people with a 50% or greater reduction in seizure frequency following enhanced phase /consolidation/maintenance treatment / 8 weeks after the end of all treatment

Secondary outcomes

  1. QOLIE-31 scale scores

    Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks

    Quality of Life in Epilepsy-31. Scores range from 0 to 100, with higher scores indicating better quality of life.

  2. scalp electroencephalogram

    Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks

    Routine scalp electroencephalogram at 40 min

  3. MRI

    Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks

    Diffusion tensor imaging，Functional MRI

  4. MoCA

    Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks

    Montreal Cognitive Assessment. A max score is 30 points, and a score ≥ 26 is considered normal.

  5. MMSE

    Time frame: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks

    Mini-Mental State Examination. The normal values are defined as: illiterates >17, primary school >20, junior high school or above >24.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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