CSWSNCT04034030
Repeated Oscillatory TMS Therapy of the Epileptogenic Cortical Area in Children With Focal CSWS
A study testing Transcranial Magnetic Stimulation in people with CSWS, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- CSWS
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 11Show fewer
- Adults unable to consent
- Pregnant women
- Prisoners
- Wards of the state
- Non English speaking subjects and families
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Overland Park, Kansas, 66211
About this study
Official title: Repeated Oscillatory Transcranial Magnetic Stimulation Therapy of the Epileptogenic Cortical Area in Children With Focal Continuous-Spike and Wave During Sleep
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.
Read the 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:
- 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.
- To look at duration of sustainability (hours) of change in SWI achieved post stimulation.
- To look at the tolerability of patients in using TRPMS.
- Conditions
- CSWS
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- magnetic brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called Trancranial Rotating Permanent Magnet Stimulator (TRPMS)
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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 Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spike-Wave Index (SWI) on EEG during sleep following one time 10 minutes of TRPMS-ECA (epileptogenic cortical area) 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.
Measured: After one single 10 minute stimulation
Secondary outcomes (1)
Duration of sustainability (hours) of change in SWI achieved post stimulation
The investigator will assess how long of a change in SWI is achieved post stimulation. This will be monitored on EEG during sleep.
Measured: After one single 10 minute stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Aug 2019
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CSWSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Cornell University
- Responsible party
- Principal investigator, Lalit Bansal, Children's Mercy Hospital Kansas City
- Investigators
- Lalit Bansal, M.D., Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034030
- Sponsor's protocol ID
- STUDY00000245
- Status last verified
- May 2026
- First submitted
- 22 Jul 2019
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Veggiotti P, Pera MC, Teutonico F, Brazzo D, Balottin U, Tassinari CA. Therapy of encephalopathy with status epilepticus during sleep (ESES/CSWS syndrome): an update. Epileptic Disord. 2012 Mar;14(1):1-11. doi: 10.1684/epd.2012.0482.
PubMed 22426353Rossini PM, Rossi S. Transcranial magnetic stimulation: diagnostic, therapeutic, and research potential. Neurology. 2007 Feb 13;68(7):484-8. doi: 10.1212/01.wnl.0000250268.13789.b2.
PubMed 17296913Chen R, Cros D, Curra A, Di Lazzaro V, Lefaucheur JP, Magistris MR, Mills K, Rosler KM, Triggs WJ, Ugawa Y, Ziemann U. The clinical diagnostic utility of transcranial magnetic stimulation: report of an IFCN committee. Clin Neurophysiol. 2008 Mar;119(3):504-532. doi: 10.1016/j.clinph.2007.10.014. Epub 2007 Dec 11.
PubMed 18063409Chen R, Spencer DC, Weston J, Nolan SJ. Transcranial magnetic stimulation for the treatment of epilepsy. Cochrane Database Syst Rev. 2016 Aug 11;(8):CD011025. doi: 10.1002/14651858.CD011025.pub2.
PubMed 27513825P41 - 1877 Low-frequency repetitive transcranial magnetic stimulation (r-TMS) treatment in children with refractory focal epilepsy: two case reports Thordstein, M et al. European Journal of Paediatric Neurology 2013, Volume 17 , S65
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Oscillatory Transcranial Magnetic Stimulation Therapy of the Epileptogenic Cortical Area in Children With Focal Continuous-Spike and Wave During Sleep
- ClinicalTrials.gov ID
- NCT04034030
- Acronym / sponsor ID
- STUDY00000245
- Conditions
- CSWS
- Keywords
- magnetic brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Cornell University
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- To look at duration of sustainability (hours) of change in SWI achieved post stimulation.
- To look at the tolerability of patients in using TRPMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Transcranial Magnetic StimulationThis 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 |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationAlso: Trancranial Rotating Permanent Magnet Stimulator (TRPMS)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. | Device | Treatment Group |
Primary outcome
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.
1 secondary outcome
Duration of sustainability (hours) of change in SWI achieved post stimulation
Time frame: After one single 10 minute stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 22426353Veggiotti P, Pera MC, Teutonico F, Brazzo D, Balottin U, Tassinari CA. Therapy of encephalopathy with status epilepticus during sleep (ESES/CSWS syndrome): an update. Epileptic Disord. 2012 Mar;14(1):1-11. doi: 10.1684/epd.2012.0482.
- Results publication: PubMed 17296913Rossini PM, Rossi S. Transcranial magnetic stimulation: diagnostic, therapeutic, and research potential. Neurology. 2007 Feb 13;68(7):484-8. doi: 10.1212/01.wnl.0000250268.13789.b2.
- Results publication: PubMed 18063409Chen R, Cros D, Curra A, Di Lazzaro V, Lefaucheur JP, Magistris MR, Mills K, Rosler KM, Triggs WJ, Ugawa Y, Ziemann U. The clinical diagnostic utility of transcranial magnetic stimulation: report of an IFCN committee. Clin Neurophysiol. 2008 Mar;119(3):504-532. doi: 10.1016/j.clinph.2007.10.014. Epub 2007 Dec 11.
- Results publication: PubMed 27513825Chen R, Spencer DC, Weston J, Nolan SJ. Transcranial magnetic stimulation for the treatment of epilepsy. Cochrane Database Syst Rev. 2016 Aug 11;(8):CD011025. doi: 10.1002/14651858.CD011025.pub2.
- Results publicationP41 - 1877 Low-frequency repetitive transcranial magnetic stimulation (r-TMS) treatment in children with refractory focal epilepsy: two case reports Thordstein, M et al. European Journal of Paediatric Neurology 2013, Volume 17 , S65
- Transcranial Brain Stimulation With Rapidly Spinning High-Field Permanent MagnetsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for CSWS
Not yet recruitingPhase 2
Melatonin for the Treatment of DEE-SWAS
CSWS, Developmental and/or Epileptic Encephalopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lalit Bansal, M.D. principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with CSWS, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04034030, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.