Wearable magnetic brain stimulation for treating epilepsy in children
Repeated Oscillatory Transcranial Magnetic Stimulation Therapy of the Epileptogenic Cortical Area in Children With Focal Continuous-Spike and Wave During Sleep
This study tests if a new wearable brain stimulation device can help children with a severe form of epilepsy feel better and improve their brain function when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 3 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT04034030 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a wearable multisite transcranial magnetic stimulation (mTMS) device designed to deliver stimuli to multiple cortical sites simultaneously or sequentially. It targets children aged 3 to 21 diagnosed with focal continuous spike and wave during sleep (CSWS), a rare and severe form of childhood epilepsy. The study aims to assess whether this non-invasive treatment can improve brain function and cognitive outcomes in patients resistant to standard drug therapies. Participants will be monitored for changes in their electroencephalogram (EEG) patterns following treatment.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 21 with a confirmed diagnosis of focal CSWS and specific EEG findings.
Not a fit: Patients with generalized CSWS or those with contraindications such as metal implants in the head will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, non-invasive option for improving cognitive function in children suffering from a debilitating form of epilepsy.
How similar studies have performed: While the use of transcranial magnetic stimulation has been explored in various neurological conditions, this specific application in children with focal CSWS is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. Additional exclusions are: * Adults unable to consent * Pregnant women * Prisoners * Wards of the state * Non English speaking subjects and families
Where this trial is running
Overland Park, Kansas
- Children's Mercy Hospital — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Lalit Bansal, M.D. — Children's Mercy Hospital Kansas City
- Study coordinator: Lalit Bansal, M.D.
- Email: lbansal@cmh.edu
- Phone: 816-302-3360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.