Study Summary
This trial is testing whether a wearable device that sends magnetic pulses to the brain can help treat epilepsy.
Treatment Effectiveness
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: After one single 10 minute stimulation
After one single 10 minute stimulation
Change in Spike-Wave Index (SWI) on EEG during sleep following one time 10 minutes of TRPMS-ECA (epileptogenic cortical area) stimulation
Duration of sustainability (hours) of change in SWI achieved post stimulation
Trial Safety
Trial Design
1 Treatment Group
Treatment Group
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: Transcranial Magnetic Stimulation · No Placebo Group · N/A
Treatment Group
Device
Experimental Group · 1 Intervention: Transcranial Magnetic Stimulation · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2011
Completed Phase 4
~580
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after one single 10 minute stimulation
Who is running the clinical trial?
Cornell UniversityOTHER
149 Previous Clinical Trials
100,840 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
239 Previous Clinical Trials
35,578 Total Patients Enrolled
Children's Mercy Hospital Kansas CityLead Sponsor
226 Previous Clinical Trials
1,269,608 Total Patients Enrolled
Lalit Bansal, M.D.Principal InvestigatorChildren's Mercy Hospital Kansas City
Eligibility Criteria
Age 3 - 21 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a minimum age of 3 years old.
You have focal CSWS as defined by ILAE.
You have a SWI of at least 85% in sleep on EEG's performed on previous or most recent EEG study.
No change in AED in last 2 weeks, or patients not on any AED.
References
- Veggiotti, Pierangelo, Maria Carmela Pera, Federica Teutonico, Daniela Brazzo, Umberto Balottin, and Carlo Alberto Tassinari. 2012. “Therapy of Encephalopathy with Status Epilepticus During Sleep (ESES/CSWS Syndrome): An Update”. Epileptic Disorders. John Libbey Eurotext. doi:10.1684/epd.2012.0482.
- Rossini, P. M., and S. Rossi. 2007. “Transcranial Magnetic Stimulation: Diagnostic, Therapeutic, and Research Potential”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/01.wnl.0000250268.13789.b2.
- 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. Review. Update in: Cochrane Database Syst Rev. 2021 Apr 15;4:CD011025.
- Chen, Robert, Didier Cros, Antonio Curra, Vincenzo Di Lazzaro, Jean-Pascal Lefaucheur, Michel R. Magistris, Kerry Mills, et al.. 2008. “The Clinical Diagnostic Utility of Transcranial Magnetic Stimulation: Report of an IFCN Committee”. Clinical Neurophysiology. Elsevier BV. doi:10.1016/j.clinph.2007.10.014.
- Rossini, P. M., and S. Rossi. 2007. “Transcranial Magnetic Stimulation: Diagnostic, Therapeutic, and Research Potential”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/01.wnl.0000250268.13789.b2.
- P41 - 1877 Low-frequency repetitive transcranial magnetic stimulation (r-TMS) treatment in children with refractory focal epilepsy: two case reports Thordstein, M et al. European Journal of Paediatric Neurology 2013, Volume 17 , S65
- 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.
- Veggiotti P, Pera MC, Teutonico F, Brazzo D, Balottin U, Tassinari CA. Therapy of encephalopathy with status epilepticus during sleep (ESES/CSWS syndrome): an update. Epileptic Disord. 2012 Mar;14(1):1-11. doi: 10.1684/epd.2012.0482.
- Chen R, Cros D, Curra A, Di Lazzaro V, Lefaucheur JP, Magistris MR, Mills K, Rosler KM, Triggs WJ, Ugawa Y, Ziemann U. The clinical diagnostic utility of transcranial magnetic stimulation: report of an IFCN committee. Clin Neurophysiol. 2008 Mar;119(3):504-532. doi: 10.1016/j.clinph.2007.10.014. Epub 2007 Dec 11.
- Rossini PM, Rossi S. Transcranial magnetic stimulation: diagnostic, therapeutic, and research potential. Neurology. 2007 Feb 13;68(7):484-8. doi: 10.1212/01.wnl.0000250268.13789.b2.
- 2019. "Repeated Oscillatory TMS Therapy of the Epileptogenic Cortical Area in Children With Focal CSWS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04034030.
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