Clinical trial NCT06558890: Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Electrical Stimulation
Temporal Lobe Epilepsy
Magnetic Resonance Imaging
Electroencephalogram
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 recruited patients with refractory TLE (Temporal Lobe Epilepsy), they will undergo a 6-week treatment with tACS (transcranial alternating current stimulation) protocol (2mA, 10Hz, 20 minutes per side), following a schedule of treatment for 5 days - rest for 2 days - treatment for another 5 days, and then a reinforcement treatment once a week, completing a total of 14 treatments.Before treatment, at week 10, and at week 14, the frequency of epileptic seizures and the QOLIE-31 questionnaire scores will be recorded and assessed for the patients. EEG data and near-infrared spectroscopy (NIRS) brain functional imaging data will be collected before treatment and after two consecutive weeks of treatment. Magnetic resonance imaging (MRI) data will be acquired before treatment, after two consecutive weeks of treatment, and after six weeks of intensified treatment. Appropriate image processing methods and EEG processing methods will be utilized to analyze the changes in brain networks following tACS treatment, in order to explore the impact of tACS on the neural mechanisms of refractory temporal lobe epilepsy (TLE).

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.

Primary outcomes:
measure: Compared to baseline, the reduction rate of epileptic seizure frequency
timeFrame: baseline, 10 weeks,14 weeks after treatment
Secondary outcomes:
measure: Quality of Life in Epilepsy-31 (QOLIE-31) Questionnaire
timeFrame: baseline, 10 weeks,14 weeks after treatment
measure: MRI measures
timeFrame: baseline，2weeks，14weeks after treatment
measure: electroencephalogram(EEG)
timeFrame: baseline，2weeks after treatment
measure: Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging
timeFrame: baseline，2weeks after treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Air Force Military Medical University
state: Shannxi
Study officials:
affiliation: The First Affiliated Hospital of Air Force Medicial University
name: Jiang Wen
role: STUDY_CHAIR
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