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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Alternating Current Stimulation Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Alternating Current Stimulation | Device | Transcranial Alternating Current Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compared to baseline, the reduction rate of epileptic seizure frequency | ((post-treatment - baseline) / baseline). | baseline, 10 weeks,14 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Calculationļ¼ the raw scores for each item on the scale can be converted to a range of 0 to 100ļ¼2.Weighted Scoringļ¼the transformed scores are multiplied by their respective weightsļ¼3.Total Score Calculation:all the weighted scores are added together to obtain the total score. Total Score=(Emotional Symptoms ScoreĆ25+Psychological Function ScoreĆ25+Social Function ScoreĆ20+Life Domains ScoreĆ17+Additional Items ScoreĆ13)/5 In the QOLIE-31 scoring system, a higher score indicates a better quality of life for individuals with epilepsy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guan Xiao, Master | Contact | 18392320919 | guanxiao0223@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Wen | The First Affiliated Hospital of Air Force Medicial University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Air Force Military Medical University | Recruiting | Xi'an | Shannxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29722352 | Background | Devinsky O, Vezzani A, O'Brien TJ, Jette N, Scheffer IE, de Curtis M, Perucca P. Epilepsy. Nat Rev Dis Primers. 2018 May 3;4:18024. doi: 10.1038/nrdp.2018.24. | |
| 29588936 | Background | Zoghi M, O'Brien TJ, Kwan P, Cook MJ, Galea M, Jaberzadeh S. Cathodal transcranial direct-current stimulation for treatment of drug-resistant temporal lobe epilepsy: A pilot randomized controlled trial. Epilepsia Open. 2016 Oct 17;1(3-4):130-135. doi: 10.1002/epi4.12020. eCollection 2016 Dec. |
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| 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. | baselineļ¼2weeksļ¼14weeks 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. | baselineļ¼2weeks 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. | baselineļ¼2weeks after treatment |
| 14747003 | Background | Theodore WH, Fisher RS. Brain stimulation for epilepsy. Lancet Neurol. 2004 Feb;3(2):111-8. doi: 10.1016/s1474-4422(03)00664-1. |
| 10392988 | Background | Tergau F, Naumann U, Paulus W, Steinhoff BJ. Low-frequency repetitive transcranial magnetic stimulation improves intractable epilepsy. Lancet. 1999 Jun 26;353(9171):2209. doi: 10.1016/S0140-6736(99)01301-X. No abstract available. |
| 27513825 | Background | Chen R, Spencer DC, Weston J, Nolan SJ. Transcranial magnetic stimulation for the treatment of epilepsy. Cochrane Database Syst Rev. 2016 Aug 11;(8):CD011025. doi: 10.1002/14651858.CD011025.pub2. |
| 30504921 | Background | Liu A, Voroslakos M, Kronberg G, Henin S, Krause MR, Huang Y, Opitz A, Mehta A, Pack CC, Krekelberg B, Berenyi A, Parra LC, Melloni L, Devinsky O, Buzsaki G. Immediate neurophysiological effects of transcranial electrical stimulation. Nat Commun. 2018 Nov 30;9(1):5092. doi: 10.1038/s41467-018-07233-7. |
| 16499758 | Background | Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x. |
| 20633376 | Background | Antal A, Boros K, Poreisz C, Chaieb L, Terney D, Paulus W. Comparatively weak after-effects of transcranial alternating current stimulation (tACS) on cortical excitability in humans. Brain Stimul. 2008 Apr;1(2):97-105. doi: 10.1016/j.brs.2007.10.001. Epub 2007 Dec 3. |
| 35366528 | Background | San-Juan D, Espinoza-Lopez DA, Vazquez-Gregorio R, Trenado C, Aragon MF, Perez-Perez D, Hernandez-Ruiz A, Anschel DJ. A pilot randomized controlled clinical trial of Transcranial Alternating Current Stimulation in patients with multifocal pharmaco-resistant epilepsy. Epilepsy Behav. 2022 May;130:108676. doi: 10.1016/j.yebeh.2022.108676. Epub 2022 Mar 30. |
| 27965623 | Background | San-Juan D, Sarmiento CI, Hernandez-Ruiz A, Elizondo-Zepeda E, Santos-Vazquez G, Reyes-Acevedo G, Zuniga-Gazcon H, Zamora-Jarquin CM. Transcranial Alternating Current Stimulation: A Potential Risk for Genetic Generalized Epilepsy Patients (Study Case). Front Neurol. 2016 Nov 28;7:213. doi: 10.3389/fneur.2016.00213. eCollection 2016. |
| 25014790 | Background | Mogul DJ, van Drongelen W. Electrical control of epilepsy. Annu Rev Biomed Eng. 2014 Jul 11;16:483-504. doi: 10.1146/annurev-bioeng-071813-104720. |
| 28928634 | Background | Tavakoli AV, Yun K. Transcranial Alternating Current Stimulation (tACS) Mechanisms and Protocols. Front Cell Neurosci. 2017 Sep 1;11:214. doi: 10.3389/fncel.2017.00214. eCollection 2017. |
| 33211157 | Background | Elyamany O, Leicht G, Herrmann CS, Mulert C. Transcranial alternating current stimulation (tACS): from basic mechanisms towards first applications in psychiatry. Eur Arch Psychiatry Clin Neurosci. 2021 Feb;271(1):135-156. doi: 10.1007/s00406-020-01209-9. Epub 2020 Nov 19. |
| 22879515 | Background | Berenyi A, Belluscio M, Mao D, Buzsaki G. Closed-loop control of epilepsy by transcranial electrical stimulation. Science. 2012 Aug 10;337(6095):735-7. doi: 10.1126/science.1223154. |
| 32035793 | Background | Streng ML, Krook-Magnuson E. The cerebellum and epilepsy. Epilepsy Behav. 2021 Aug;121(Pt B):106909. doi: 10.1016/j.yebeh.2020.106909. Epub 2020 Feb 5. |
| ID | Term |
|---|---|
| D004833 | Epilepsy, Temporal Lobe |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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