RecruitingNot ApplicableNCT06558890
Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy
A Study on the Efficacy and Mechanism of Targeted Cerebellar Transcranial Electrical Stimulation for the Treatment of Refractory Temporal Lobe Epilepsy: A Single-center, Observational Study.
Sponsor
Xijing Hospital
Enrollment
60 participants
Start Date
Jun 8, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria6
- 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 Criteria9
- 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.
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Interventions
DEVICETranscranial Alternating Current Stimulation
Transcranial Alternating Current Stimulation
Locations(1)
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NCT06558890
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