Status:
RECRUITING
Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy
Lead Sponsor:
Xijing Hospital
Conditions:
Transcranial Electrical Stimulation
Temporal Lobe Epilepsy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Study the therapeutic effect and potential neural mechanisms of transcranial electrical stimulation targeting the cerebellum for the treatment of refractory temporal lobe epilepsy through MRI and EEG.
Detailed Description
This study is a single-center, observational study.This study applies transcranial alternating current stimulation to the cerebellum of patients with refractory temporal lobe epilepsy.For the recruite...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years old;
- 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);
- 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;
- Taking two or more antiepileptic drugs, and continuing the same medication treatment plan during the trial period;
- Capable of cooperating to complete the treatment and related examination items;
- The patient and family members fully understand and voluntarily sign the informed consent form.
Exclusion
- Scalp skin damage (including skin diseases or damage in the area where electrodes are applied);
- Psychogenic epilepsy or pseudo-epilepsy;
- 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;
- Presence of any implanted devices or instruments (such as cardiac pacemakers, deep brain stimulators, cochlear implants, and vagus nerve stimulators, etc.);
- History of head trauma or other brain-related diseases;
- Pregnant or breastfeeding women;
- Participation in other clinical trials at the same time;
- Changes in medication treatment plan during baseline, treatment, or follow-up period;
- Withdrawal of informed consent by the patient or family members.
Key Trial Info
Start Date :
June 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06558890
Start Date
June 8 2024
End Date
December 31 2024
Last Update
August 19 2024
Active Locations (1)
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1
Xijing Hospital of Air Force Military Medical University
Xi'an, Shannxi, China