Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04034030
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborators:
The Methodist Hospital System
Cornell University
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

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.

Condition or disease Intervention/treatment Phase
CSWS Device: Transcranial Magnetic Stimulation Not Applicable

Detailed Description:

Continuous Spike and Wave during Sleep (CSWS) is a rare neurological disease with an incidence of 0.2 - 0.5% of childhood epilepsy. It is often accompanied by comprehensive damage to brain function and associated neurodevelopmental problems. It is an epileptic syndrome which seriously affects the cognitive function of children. While it can be treated with drugs, other modalities are being sought, especially, in cases that are resistant to standard treatment. One such approach that is being tested is repetitive magnetic stimulation (rTMS). Noninvasive magnet stimulation of the cerebral cortex is an important and useful technique in neuroscience research, as well as in diagnostic and therapeutic clinical investigations. Over the last three decades the magnetic stimulation procedure is being carried out using a device called transcranial magnetic stimulator (TMS), which uses a large hand-held electromagnetic coil passing high amplitude current to induce her rapid changing magnetic field at a single cortical site. TMS has found clinical application several neurological and psychiatric conditions such as stroke, major depression, migraine, movement disorders and Tourette syndrome. One limitation of conventional TMS, besides the bulkiness of the device and large amount of current involved, is that it allows stimulation at only one cortical site at a time.Dr. Santosh Helekar of Houston Methodist Research Institute (HMRI) and Dr. Henning Voss of Weill-Cornell Medical College (WCMC) have developed a compact portable and wearable multisite transcranial magnetic stimulation device called Transcranial Rotating Permanent Magnet Stimulator (TRPMS) that can deliver stimuli at multiple cortical sites simultaneously or sequentially. It uses rapidly rotating small high-strength permanent magnets to induce currents in the brain. As opposed to conventional TMS, the TRPMS device is also ideally suited to conduct double blinded placebo controlled studies because undetectable demagnetized magnets can be intermixed with actual magnet to allow rapid rotation of either type of magnets to be activated and one in the same device in a randomized protocol. Under a previously approved HMRI study protocol this new device has been shown to induce motor-evoked potentials (MEPs) in the thenar muscles by highly focused stimulation of the cortical representation in the precentral gyrus.

In the present study, the investigators would like to conduct a test to see the therapeutic effectiveness of focused TRPMS stimulation of the epileptogenic region found on scalp electroencephalogram (EEG) in patients with focal CSWS. The specific aim of the study are:

  1. To look at the immediate benefit obtained by CSWS patients subjected to 10 minutes of one-time TRPMS-ECA (epileptogenic cortical area) stimulation; evaluated as a reduction in Spike-Wave Index (SWI) on EEG during sleep.
  2. To look at duration of sustainability (hours) of change in SWI achieved post stimulation.
  3. To look at the tolerability of patients in using TRPMS.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repeated Oscillatory Transcranial Magnetic Stimulation Therapy of the Epileptogenic Cortical Area in Children With Focal Continuous-Spike and Wave During Sleep
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 31, 2020


Arm Intervention/treatment
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
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.

Other Name: Trancranial Rotating Permanent Magnet Stimulator (TRPMS)




Primary Outcome Measures :
  1. Change in Spike-Wave Index (SWI) on EEG during sleep following one time 10 minutes of TRPMS-ECA (epileptogenic cortical area) stimulation [ Time Frame: After one single 10 minute 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.


Secondary Outcome Measures :
  1. Duration of sustainability (hours) of change in SWI achieved post stimulation [ Time Frame: After one single 10 minute stimulation ]
    The investigator will assess how long of a change in SWI is achieved post stimulation. This will be monitored on EEG during sleep.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034030


Contacts
Layout table for location contacts
Contact: Lalit Bansal, M.D. 816-302-3360 lbansal@cmh.edu

Locations
Layout table for location information
United States, Kansas
Children's Mercy Hospital Recruiting
Overland Park, Kansas, United States, 66211
Contact: Lalit Bansal, M.D.    816-302-3360    lbansal@cmh.edu   
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
The Methodist Hospital System
Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Lalit Bansal, M.D. Children's Mercy Hospital Kansas City
  Study Documents (Full-Text)

Documents provided by Children's Mercy Hospital Kansas City:
Informed Consent Form  [PDF] June 14, 2019

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT04034030    
Other Study ID Numbers: STUDY00000245
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Children's Mercy Hospital Kansas City:
magnetic brain stimulation