Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy

Launched by XIJING HOSPITAL · Aug 16, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for people with temporal lobe epilepsy that doesn't respond well to standard medications. The treatment involves a method called transcranial electrical stimulation, which sends small electrical currents to the brain's cerebellum, a part that helps with movement and coordination. Researchers want to see if this technique can help reduce seizures and understand how it works by using imaging tools like MRI and EEG.

To be eligible for this study, participants need to be between 18 and 65 years old and have been diagnosed with refractory temporal lobe epilepsy, meaning they have not found relief from seizures despite trying at least two different anti-seizure medications. They should have experienced seizures at least twice in the last month and have been living with epilepsy for at least two years. Participants will continue their current medications during the trial and will need to agree to the study by signing an informed consent form. If someone is interested in joining, they should be aware that certain health conditions, skin issues, or implanted devices may prevent them from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 65 years old;
• • 2. Diagnosed with refractory temporal lobe epilepsy as defined by the International League Against Epilepsy (ILAE) (failure to achieve seizure-free status after adequate trials of two appropriate antiepileptic drugs);
• • 3. Duration of epilepsy is at least 2 years, with a seizure frequency of at least 2 times per 4 weeks in the three months before enrollment;
• • 4. Taking two or more antiepileptic drugs, and continuing the same medication treatment plan during the trial period;
• • 5. Capable of cooperating to complete the treatment and related examination items;
• • 6. The patient and family members fully understand and voluntarily sign the informed consent form.
• Exclusion Criteria:
• • 1. Scalp skin damage (including skin diseases or damage in the area where electrodes are applied);
• • 2. Psychogenic epilepsy or pseudo-epilepsy;
• • 3. Concurrent severe infections, cerebrovascular diseases, malignant tumors, or other diseases with severe dysfunction of major organs such as the heart, liver, and kidneys, or with mental disorders;
• • 4. Presence of any implanted devices or instruments (such as cardiac pacemakers, deep brain stimulators, cochlear implants, and vagus nerve stimulators, etc.);
• • 5. History of head trauma or other brain-related diseases;
• • 6. Pregnant or breastfeeding women;
• • 7. Participation in other clinical trials at the same time;
• • 8. Changes in medication treatment plan during baseline, treatment, or follow-up period;
• • 9. Withdrawal of informed consent by the patient or family members.