Status EpilepticusSURESTEPNCT03819543
SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus
A study testing Transcranial Direct Current Stimulation in people with Status Epilepticus, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether transcranial direct current stimulation affects super refractory status epilepticus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of super refractory status epilepticus
- admitted to the intensive care unit
- identifiable epileptogenic focus on EEG
Who cannot join
- contraindications to scalp EEG
- lice
- scabies
- other hair/skin infection
- scalp psoriasis
- hypersensitivity
Show all 11Show fewer
- other severe dermatological condition
- previous adverse reaction to collodion
- vagal nerve stimulator
- implantable cardioverter defibrillator
- cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation in SUper REfractory STatus EPilepticus (SURESTEP): Pilot Study of a Novel Therapy in a Common Medical Emergency
The purpose of this study is to determine whether transcranial direct current stimulation affects super refractory status epilepticus.
- Conditions
- Status Epilepticus
- Being tested
- Transcranial Direct Current Stimulation
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Not described Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Epileptiform Activity, Per Patient-based
EEG epileptiform activity as defined in units of spikes per second for a given patient. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.
Measured: Up to 3 hours per EEG recording
Secondary outcomes (1)
Frequency of Epileptiform Activity, Per-session Based
EEG epileptiform activity as defined in units of spikes per second for a given stimulation session. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.
Measured: Up to 3 hours per EEG recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start15 Jul 2019
- Primary completion30 Nov 2020
- Study completion31 Aug 2021
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Status EpilepticusStudies 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
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Responsible party
- Sponsor
- Investigators
- Marcus Ng, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819543
- Sponsor's protocol ID
- B2018:133
- Acronym
- SURESTEP
- Status last verified
- Nov 2020
- First submitted
- 21 Jan 2019
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation in SUper REfractory STatus EPilepticus (SURESTEP): Pilot Study of a Novel Therapy in a Common Medical Emergency
- ClinicalTrials.gov ID
- NCT03819543
- Acronym / sponsor ID
- SURESTEP / B2018:133
- Conditions
- Status Epilepticus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether transcranial direct current stimulation affects super refractory status epilepticus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Device: Transcranial Direct Current Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of super refractory status epilepticus
- admitted to the intensive care unit
- identifiable epileptogenic focus on EEG
Key exclusion criteria (11 listed)
- contraindications to scalp EEG
- lice
- scabies
- other hair/skin infection
- scalp psoriasis
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 Direct Current StimulationApplication of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA. | Device | Transcranial Direct Current Stimulation |
Primary outcome
Frequency of Epileptiform Activity, Per Patient-based
Time frame: Up to 3 hours per EEG recording
EEG epileptiform activity as defined in units of spikes per second for a given patient. Pre-stim compares spike rates during stimulation to before stimulation. Pre-post compares spike rates after stimulation to before stimulation.
1 secondary outcome
Frequency of Epileptiform Activity, Per-session Based
Time frame: Up to 3 hours per EEG recording
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marcus Ng, MD principal investigator
University of Manitoba
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 Direct Current Stimulation in people with Status Epilepticus, run by University of Manitoba at 1 site in Canada.
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 3 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: stopped early, as of the sponsor's last update on 16 Feb 2023. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Epileptiform Activity, Per Patient-based (time frame: Up to 3 hours per EEG recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2023.