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

NCT04034030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

DEVICE

Transcranial Magnetic Stimulation

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.

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Cornell University

    collaborator OTHER

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Lalit Bansal, M.D. · Children's Mercy Hospital Kansas City

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2026-05-06
Completion
2026-05-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04034030 on ClinicalTrials.gov