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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Transcranial Magnetic Stimulation; Drug-resistant Epilepsy
• Intervention / Treatment: Device: cTBS

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Participants who are in status epilepticus,
2. 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,
3. Participants plan invasive therapy, such as operation,
4. Participants who are in pregnancy or lactating,
5. Patients cannot tolerate repeated transcranial magnetic stimulation, or have contraindications of repeated transcranial magnetic stimulation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participant Group; 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.

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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seizure reduction rate	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	Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
responder rate	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	Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOLIE-31 scale scores	Quality of Life in Epilepsy-31. Scores range from 0 to 100, with higher scores indicating better quality of life.	Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
scalp electroencephalogram	Routine scalp electroencephalogram at 40 min	Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
MRI	Diffusion tensor imaging，Functional MRI	Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
MoCA	Montreal Cognitive Assessment. A max score is 30 points, and a score ≥ 26 is considered normal.	Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
MMSE	Mini-Mental State Examination. The normal values are defined as: illiterates >17, primary school >20, junior high school or above >24.	Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 28, 2025
• Primary Completion (Estimated): March 27, 2027
• Study Completion (Estimated): March 27, 2027

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 16, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy
• Other Study ID Numbers: KY20252042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No