Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy
- Conditions
- Temporal Lobe EpilepsyElectroencephalogramTranscranial Electrical StimulationMagnetic Resonance Imaging
- Interventions
- Device: Transcranial Alternating Current Stimulation
- Registration Number
- NCT06558890
- Lead Sponsor
- Xijing Hospital
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transcranial Alternating Current Stimulation Intervention Transcranial Alternating Current Stimulation Patients with refractory TLE recruited for the study will undergo a 6-week treatment with the tACS (transcranial alternating current stimulation) protocol, which involves a 2mA current at 10Hz for 20 minutes on both sides. The treatment schedule is 5 days of treatment followed by 2 days of rest, and then another 5 days of treatment, with a weekly reinforcement treatment, for a total of 14 sessions.
- Primary Outcome Measures
Name Time Method Compared to baseline, the reduction rate of epileptic seizure frequency baseline, 10 weeks,14 weeks after treatment ((post-treatment - baseline) / baseline).
- Secondary Outcome Measures
Name Time Method Quality of Life in Epilepsy-31 (QOLIE-31) Questionnaire baseline, 10 weeks,14 weeks after treatment The scoring method for the QOLIE-31 Questionnaire involves several key steps, as follows:1.Initial Score Calculation： the raw scores for each item on the scale can be converted to a range of 0 to 100；2.Weighted Scoring：the transformed scores are multiplied by their respective weights；3.Total Score Calculation:all the weighted scores are added together to obtain the total score. Total Score=(Emotional Symptoms Score×25+Psychological Function Score×25+Social Function Score×20+Life Domains Score×17+Additional Items Score×13)/5 In the QOLIE-31 scoring system, a higher score indicates a better quality of life for individuals with epilepsy.
Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging baseline，2weeks after treatment Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging can assess the changes in brain function of patients before and after transcranial electrical stimulation (TES) treatment.Changes in brain functional connectivity as measured by near-infrared spectroscopy (fNIRS) imaging before and after transcranial electrical stimulation treatment.
MRI measures baseline，2weeks，14weeks after treatment This study primarily applied resting-state blood oxygen level dependent functional magnetic resonance imaging (BOLD) and magnetic resonance diffusion tensor imaging (DTI) techniques to evaluate the changes in functional connectivity of the cerebellum in healthy subjects and patients before and after two weeks of transcranial electrical stimulation (TES) treatment, as well as the changes in the cerebellar cortical white matter fiber bundles two months after treatment. ALFF and ReHo analyses can reveal the characteristics of local neural activity in the brain during the resting state, and abnormal brain regions can serve as regions of interest (ROIs) for subsequent functional connectivity analysis. Additionally, the flow of cerebrospinal fluid (CSF) can be measured to reflect the functional state of the glymphatic system, which can be used to assess the therapeutic effects and the impact on lymphatic drainage function.
electroencephalogram(EEG) baseline，2weeks after treatment The changes in EEG will constitute secondary research outcomes. EEG can evaluate the changes in brain functional connectivity in patients before and after transcranial electrical stimulation (TES) treatment. In addition, the alterations in the power spectrum of each frequency band, including delta, alpha, beta, theta, low gamma, and high gamma, will also be measured before and after TES treatment.
Trial Locations
- Locations (1)
Xijing Hospital of Air Force Military Medical University
🇨🇳Xi'an, Shannxi, China