Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy
NCT Number: NCT06558890
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transcranial Electrical Stimulation|Temporal Lobe Epilepsy|Magnetic Resonance Imaging|Electroencephalogram
Interventions: DEVICE: Transcranial Alternating Current Stimulation
Sponsor: Xijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-08
Completion Date: 2024-12-31
Locations: Xijing Hospital of Air Force Military Medical University, Xi'an, Shannxi, China

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.

Primary Outcome Measures: Compared to baseline, the reduction rate of epileptic seizure frequency, ((post-treatment - baseline) / baseline)., baseline, 10 weeks,14 weeks after treatment
Secondary Outcome Measures: Quality of Life in Epilepsy-31 (QOLIE-31) Questionnaire, 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., baseline, 10 weeks,14 weeks after treatment|MRI measures, 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., baseline，2weeks，14weeks after treatment|electroencephalogram(EEG), 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., baseline，2weeks after treatment|Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging, 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., baseline，2weeks after treatment