Using electrical stimulation on the cerebellum to treat difficult-to-control 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.

This study is testing if a new type of brain stimulation can help people with hard-to-treat temporal lobe epilepsy have fewer seizures and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shannxi)
• Trial ID: NCT06558890 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of transcranial alternating current stimulation (tACS) on patients with refractory temporal lobe epilepsy (TLE). Participants will receive a series of tACS treatments over six weeks, with their seizure frequency and quality of life assessed before, during, and after the treatment period. The study will also utilize MRI and EEG to analyze changes in brain activity and networks resulting from the stimulation. The goal is to understand the therapeutic effects and underlying neural mechanisms of this approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with refractory temporal lobe epilepsy who have not achieved seizure control with standard medications.

Not a fit: Patients with scalp skin damage, psychogenic epilepsy, or severe concurrent medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce seizure frequency and improve the quality of life for patients with refractory temporal lobe epilepsy.

How similar studies have performed: While the use of transcranial electrical stimulation is gaining interest, this specific approach targeting the cerebellum for refractory TLE is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Xi'an, Shannxi

• Xijing Hospital of Air Force Military Medical University — Xi'an, Shannxi, China (Recruiting)

Study contacts

• Study coordinator: Guan Xiao, Master

Conditions Transcranial Electrical Stimulation; Temporal Lobe Epilepsy; Magnetic Resonance Imaging; Electroencephalogram