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

Launched by XIJING HOSPITAL · Feb 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with drug-resistant epilepsy (DRE), which means their seizures don’t respond well to medications. The researchers will use a technique called Transcranial Magnetic Stimulation (TMS) that targets a specific area in the brain called the cerebellum. The goal is to see how effective and safe this treatment is over a long period of time, with the hope of helping patients have better control over their seizures and improve their quality of life. The trial will involve 100 participants who will receive this treatment and have their seizure frequency and overall health assessed at different stages during the study.

To participate in this trial, individuals need to be between 18 and 65 years old and have been diagnosed with drug-resistant epilepsy for at least two years, experiencing two or more seizures each month in the last three months. Participants and their families must understand the study and agree to take part. However, those who are currently experiencing severe seizures, have certain health issues, are pregnant or breastfeeding, or cannot tolerate the TMS treatment will not be eligible. Throughout the trial, participants can expect regular check-ins and assessments to monitor their progress and safety.

Gender

ALL

Eligibility criteria

• 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.