Repeated Oscillatory Transcranial Magnetic Stimulation Therapy of the Epileptogenic Cortical Area in Children With Focal Continuous-Spike and Wave During Sleep
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 21
Healthy Volunteers: f
View:
• 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
Locations
United States
Kansas
Children's Mercy Hospital
RECRUITING
Overland Park
Contact Information
Primary
Lalit Bansal, M.D.
lbansal@cmh.edu
816-302-3360
Time Frame
Start Date: 2019-08-01
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 10
Treatments
Experimental: Treatment Group
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
Related Therapeutic Areas
Sponsors
Leads: Children's Mercy Hospital Kansas City
Collaborators: The Methodist Hospital Research Institute, Cornell University