cTBS Targeting Cerebellum for Drug-refractory Epilepsy

NCT05042726 | Completed

• 1 other identifier: XijingSN
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to observe the effect and safety of cerebellar continuous θ burst stimulation (cTBS) for drug-refractory epilepsy(DRE), in order to provide a new treatment for DRE and improve the quality of life of those patients. A total of 44 patients with DRE will have cTBS via accurate navigation to bilateral cerebellar dentate nuclei. Patients will be randomised into 2 groups in a crossover trial design to have 2 week periods of cTBS separated by 8 week washout periods, following which the patient will cross over to have the opposite condition for a further 2 week. Frequency and symptoms of seizures, scalp EEG, clinical scores, and QOLIE-31 were assessed at baseline and after 1 and 2 month of treatment.

Conditions

Drug Refractory Epilepsy

Keywords

Drug Refractory Epilepsy; Continuous θ Burst Stimulation; Cerebellar Dentate Nucleus

Outcome Measures

Primary Outcomes (2)

• seizure reduction rate in pre- and post-treatment

  A 28-day baseline for seizure frequency will be recorded by the patients themselves or their relatives before therapy and then compare to the frequency at 4-week and 8-week after treatment, finally, the rate of reduction in seizure frequency was obtained

  8 weeks

• responder rate

  proportion of people with a 50% or greater reduction in seizure frequency following the treatment period

  8 weeks

Secondary Outcomes (9)

• QOLIE-31 scale scores

  8 weeks

• scalp electroencephalogram

  8 weeks

• IQ

  8 weeks

• MQ

  8 weeks

• MoCA

  8 weeks

Study Arms (2)

cTBS First

EXPERIMENTAL

The first stage, participants received cTBS treatment for a total of 10 times during two weeks, then followed up for eight weeks; the second stage, participants are treated with pseudo-stimulation for a total of 10 times during two weeks, then followed up for 8 weeks similarly.

Device: cTBS First

Pseudo-stimulation First

EXPERIMENTAL

The first stage, participants received pseudo-stimulation treatment for a total of 10 times during two weeks, then followed up for eight weeks; the second stage, participants are treated with cTBS for a total of 10 times during two weeks, then followed up for 8 weeks similarly.

Device: Pseudo-stimulation First

Interventions

cTBS First DEVICE

Continuous θ-burst stimulation (cTBS) is characterized by plexus stimulation. The stimulation intensity was 80% resting motor threshold (RMT) at 50Hz of intra plexus pulse while the frequency of inter plexus pulse is 5Hz, the duration was 33.2s, and the number of stimulation pulses was 600. Two groups of stimulation were repeated in each cerebellar dentate nucleus with an interval of 5 min in each group.

cTBS First

Pseudo-stimulation First DEVICE

The transcranial magnetic stimulator operating system has a built-in control group option, in which the stimulation parameters are set consistent with the research group, which can realize the operation of only sound without stimulation.

Pseudo-stimulation First

Eligibility Criteria

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

You may qualify if:

• a) Participants who are in line with the diagnostic criteria for epilepsy,
• b) Participants who are diagnosed as drug-refractory epilepsy,
• c) Participants who has duration of epilepsy ≥2 years and seizure frequency ≥2 times per month,
• d) The type and dosage of anti-epileptic drugs do not change during the experiment,
• e) Participants or their families reject invasive therapy, such as operation,
• f) Participants and their families are aware of this study and sign informed consent.

You may not qualify if:

• a) Participants who are in status epilepticus,
• b) Participants who are complicated with serious infection, cerebrovascular disease, malignant tumor and other nervous system diseases, with serious dysfunction of heart, liver, kidney and other organs, and with psychiatric disorders,
• c) Participants who are diagnosed as syncope, hysteria or other non-epileptic attacks,
• d) Participants who are in pregnancy or lactating,
• e) Participants who have incomplete clinical data,
• f) Patients have contraindications of repeated transcranial magnetic stimulation.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (10)

• Theodore WH, Spencer SS, Wiebe S, Langfitt JT, Ali A, Shafer PO, Berg AT, Vickrey BG. Epilepsy in North America: a report prepared under the auspices of the global campaign against epilepsy, the International Bureau for Epilepsy, the International League Against Epilepsy, and the World Health Organization. Epilepsia. 2006 Oct;47(10):1700-22. doi: 10.1111/j.1528-1167.2006.00633.x.

  PMID: 17054693 BACKGROUND

• Forsgren L, Beghi E, Oun A, Sillanpaa M. The epidemiology of epilepsy in Europe - a systematic review. Eur J Neurol. 2005 Apr;12(4):245-53. doi: 10.1111/j.1468-1331.2004.00992.x.

  PMID: 15804240 BACKGROUND

• Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

  PMID: 10660394 BACKGROUND

• George MS, Aston-Jones G. Noninvasive techniques for probing neurocircuitry and treating illness: vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). Neuropsychopharmacology. 2010 Jan;35(1):301-16. doi: 10.1038/npp.2009.87.

  PMID: 19693003 BACKGROUND

• Hsu WY, Cheng CH, Lin MW, Shih YH, Liao KK, Lin YY. Antiepileptic effects of low frequency repetitive transcranial magnetic stimulation: A meta-analysis. Epilepsy Res. 2011 Oct;96(3):231-40. doi: 10.1016/j.eplepsyres.2011.06.002. Epub 2011 Jun 29.

  PMID: 21715144 BACKGROUND

• Cooper YA, Pianka ST, Alotaibi NM, Babayan D, Salavati B, Weil AG, Ibrahim GM, Wang AC, Fallah A. Repetitive transcranial magnetic stimulation for the treatment of drug-resistant epilepsy: A systematic review and individual participant data meta-analysis of real-world evidence. Epilepsia Open. 2017 Dec 27;3(1):55-65. doi: 10.1002/epi4.12092. eCollection 2018 Mar.

  PMID: 29588988 BACKGROUND

• Chung SW, Hill AT, Rogasch NC, Hoy KE, Fitzgerald PB. Use of theta-burst stimulation in changing excitability of motor cortex: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2016 Apr;63:43-64. doi: 10.1016/j.neubiorev.2016.01.008. Epub 2016 Feb 3.

  PMID: 26850210 BACKGROUND

• Koc G, Gokcil Z, Bek S, Kasikci T, Eroglu E, Odabasi Z. Effects of continuous theta burst transcranial magnetic stimulation on cortical excitability in patients with idiopathic generalized epilepsy. Epilepsy Behav. 2017 Dec;77:26-29. doi: 10.1016/j.yebeh.2017.09.011. Epub 2017 Oct 23.

  PMID: 29073474 BACKGROUND

• Brighina F, Daniele O, Piazza A, Giglia G, Fierro B. Hemispheric cerebellar rTMS to treat drug-resistant epilepsy: case reports. Neurosci Lett. 2006 Apr 24;397(3):229-33. doi: 10.1016/j.neulet.2005.12.050. Epub 2006 Jan 19.

  PMID: 16426754 BACKGROUND

• Krook-Magnuson E, Szabo GG, Armstrong C, Oijala M, Soltesz I. Cerebellar Directed Optogenetic Intervention Inhibits Spontaneous Hippocampal Seizures in a Mouse Model of Temporal Lobe Epilepsy. eNeuro. 2014 Dec;1(1):ENEURO.0005-14.2014. doi: 10.1523/ENEURO.0005-14.2014.

  PMID: 25599088 BACKGROUND

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 13, 2021
• Study Start: August 2, 2021
• Primary Completion: August 24, 2022
• Study Completion: August 26, 2022
• Last Updated: January 5, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)