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Device

TMS Therapy for Epilepsy

N/A

Recruiting

Led By Lalit Bansal, M.D.

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients between the ages of 3 and 21 years old

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after one single 10 minute stimulation

Awards & highlights

Study Summary

This trial is testing whether a wearable device that sends magnetic pulses to the brain can help treat epilepsy.

Who is the study for?

This trial is for children and young adults aged 3 to 21 with a specific type of epilepsy called focal CSWS. They must have stable medication use for the last two weeks or not be on any epilepsy drugs, and their recent EEG should show a SWI of ≥ 85% during sleep.Check my eligibility

What is being tested?

The study tests a wearable device that uses transcranial magnetic stimulation (TMS) to target multiple areas of the brain either at once or in sequence, aiming to treat seizures associated with focal CSWS.See study design

What are the potential side effects?

TMS may cause discomfort at the stimulation site, headache, lightheadedness, or twitching facial muscles. In rare cases, it could lead to seizures but this is uncommon especially in a controlled clinical setting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 3 and 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after one single 10 minute stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after one single 10 minute stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and after one single 10 minute stimulation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation

2017

Completed Phase 4

~730

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cornell UniversityOTHER

166 Previous Clinical Trials

14,089,850 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

274 Previous Clinical Trials

80,525 Total Patients Enrolled

Children's Mercy Hospital Kansas CityLead Sponsor

245 Previous Clinical Trials

935,789 Total Patients Enrolled

Media Library

Multisite Transcranial Magnetic Stimulation (mTMS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04034030 — N/A

Subcortical White Matter Disease Research Study Groups: Treatment Group

Subcortical White Matter Disease Clinical Trial 2023: Multisite Transcranial Magnetic Stimulation (mTMS) Highlights & Side Effects. Trial Name: NCT04034030 — N/A

Multisite Transcranial Magnetic Stimulation (mTMS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04034030 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to become a participant in this research endeavor?

"Eligible patients must have csws and fall between the age range of 3 to 21. A total of 10 participants are needed for this investigation."

Answered by AI

How many subjects are benefitting from this clinical research?

"Yes, the clinicaltrials.gov website confirms that this experiment is presently in search of participants. First posted on August 1st 2019 and last updated June 3rd 2022, it seeks to recruit 10 patients from a single location."

Answered by AI

Is there space available in this research protocol for more participants?

"Indeed, the information hosted on clinicaltrials.gov indicates that this research is still recruiting participants. This trial was first published in August 2019 and has been updated as recently as June 2022; it seeks to enrol 10 patients through a single medical centre."

Answered by AI