Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy

NCT06558890 | Recruiting

• 1 other identifier: KY20232387
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Compared to baseline, the reduction rate of epileptic seizure frequency

  ((post-treatment - baseline) / baseline).

  baseline, 10 weeks,14 weeks after treatment

Secondary Outcomes (4)

• Quality of Life in Epilepsy-31 (QOLIE-31) Questionnaire

  baseline, 10 weeks,14 weeks after treatment

• MRI measures

  baseline，2weeks，14weeks after treatment

• electroencephalogram(EEG)

  baseline，2weeks after treatment

• Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging

  baseline，2weeks after treatment

Study Arms (1)

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.

Device: Transcranial Alternating Current Stimulation

Interventions

Transcranial Alternating Current Stimulation DEVICE

Transcranial Alternating Current Stimulation

Transcranial Alternating Current Stimulation Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital of Air Force Military Medical University

Xi'an, Shannxi, China

RECRUITING

Related Publications (15)

• 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.

  PMID: 29722352 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.

  PMID: 29588936 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.

  PMID: 14747003 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.

  PMID: 10392988 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.

  PMID: 27513825 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.

  PMID: 30504921 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.

  PMID: 16499758 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.

  PMID: 20633376 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.

  PMID: 35366528 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.

  PMID: 27965623 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.

  PMID: 25014790 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.

  PMID: 28928634 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.

  PMID: 33211157 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.

  PMID: 22879515 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.

  PMID: 32035793 BACKGROUND

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jiang Wen

  The First Affiliated Hospital of Air Force Medicial University

  STUDY CHAIR

Central Study Contacts

Guan Xiao, Master

CONTACT

18392320919; guanxiao0223@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 19, 2024
• Study Start: June 8, 2024
• Primary Completion: August 11, 2024
• Study Completion: December 31, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)