Repeated Oscillatory TMS Therapy of the Epileptogenic Cortical Area in Children With Focal CSWS

NCT04034030 | Recruiting FDA Device

• 1 other identifier: STUDY00000245
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are investigating the effectiveness of a wearable multisite transcranial magnetic stimulation (mTMS) device that can deliver stimuli at multiple cortical sites simultaneously or sequentially for the treatment of an epileptic syndrome - focal continuous-spike and wave during sleep.

Conditions

CSWS

Keywords

magnetic brain stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Spike-Wave Index (SWI) on EEG during sleep following one time 10 minutes of TRPMS-ECA (epileptogenic cortical area) stimulation

  The Investigators will assess if treatment had any effect on SWI. SWI is measured on EEG during sleep and is defined as percentage of time during sleep where epileptiform discharges are noted. CSWS is defined as SWI of ≥ 85% during sleep. First 30 minutes of sleep will be scored for comparison of pre and post stimulation.

  After one single 10 minute stimulation

Secondary Outcomes (1)

• Duration of sustainability (hours) of change in SWI achieved post stimulation

  After one single 10 minute stimulation

Study Arms (1)

Treatment Group

EXPERIMENTAL

This study will be conducted over one year in 10 focal CSWS patients ranging in age from 3 to 21 years. The patients will be recruited from the large patient population that is served by the Children's Mercy Comprehensive Epilepsy Monitoring Unit (EMU) in Overland Park, Kansas. Subjects will be identified from these EMU patient population. Those meeting inclusion criteria will be approached for possible enrollment. Inclusion criteria will be defined by patients that were diagnosed with focal CSWS in accordance with the ILAE classification with SWI \>85% during NREM sleep on their previous or most recent EEG. Patients and their parents/guardians will provide assent/consent for participation in the study after being briefed on the nature of the study, by reading and signing assent and assent/consent forms, respectively

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Each patient will receive a 10 minute treatment of one time stimulation of the Epileptogenic Cortical Area (ECA). The TRPMS cap will be worn over the previously fixed scalp EEG electrodes. The procedure during this treatment session will consist of positioning a device microstimulator component centered on an area of focal epileptiform discharges (identified with EEG electrode placement) with the patient relaxing in a chair. The stimulus parameters used will be 120 stimulus trains of 100 ms in duration, each train delivered every 5 s for total session duration of 10 min. . The investigators will measure the subject for adequate placement of the device prior to stimulation. Once the placement of the device is confirmed, the study technician administrating the treatment will turn on the device using the app downloaded on an electronic device connected by Bluetooth to the device.

Also known as: Trancranial Rotating Permanent Magnet Stimulator (TRPMS)

Treatment Group

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between the ages of 3 and 21 years old,
• An electroclinical diagnosis of focal CSWS as defined by ILAE
• SWI of ≥ 85% in sleep on EEG's performed on previous or most recent EEG study.
• No change in antiepileptic drugs (AED) in last 2 week, or patients not on any AED

You may not qualify if:

• Presence of metal implants or metallic devices in the head
• Any history of drug or alcohol abuse
• Presence of cardiac pacemaker
• Generalized CSWS
• All study patients will be enrolled for treatment with TMS to see if this modality of treatment has any effect on SWI on CSWS.
• Adults unable to consent
• Pregnant women
• Prisoners
• Wards of the state
• Non English speaking subjects and families

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• The Methodist Hospital Research Institute: collaborator
• Cornell University: collaborator

Study Sites (1)

Children's Mercy Hospital

Overland Park, Kansas, 66211, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 22426353 RESULT

• 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.

  PMID: 17296913 RESULT

• 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.

  PMID: 18063409 RESULT

• 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 RESULT

• 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

  RESULT

Related Links

• Transcranial Brain Stimulation With Rapidly Spinning High-Field Permanent Magnets

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Lalit Bansal, M.D.

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lalit Bansal, M.D.

CONTACT

816-302-3360; lbansal@cmh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 26, 2019
• Study Start: August 1, 2019
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)