Study Stopped
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SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus
SURESTEP
Transcranial Direct Current Stimulation in SUper REfractory STatus EPilepticus (SURESTEP): Pilot Study of a Novel Therapy in a Common Medical Emergency
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to determine whether transcranial direct current stimulation affects super refractory status epilepticus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2019
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedStudy Start
First participant enrolled
July 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedResults Posted
Study results publicly available
February 16, 2023
CompletedFebruary 16, 2023
November 1, 2020
1.4 years
January 21, 2019
November 1, 2022
January 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 3 hours per EEG recording
Secondary Outcomes (1)
Frequency of Epileptiform Activity, Per-session Based
Up to 3 hours per EEG recording
Study Arms (1)
Transcranial Direct Current Stimulation
EXPERIMENTALInterventions
Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA.
Eligibility Criteria
You may qualify if:
- diagnosis of super refractory status epilepticus
- admitted to the intensive care unit
- identifiable epileptogenic focus on EEG
You may not qualify if:
- contraindications to scalp EEG
- lice
- scabies
- other hair/skin infection
- scalp psoriasis
- hypersensitivity
- other severe dermatological condition
- previous adverse reaction to collodion
- vagal nerve stimulator
- implantable cardioverter defibrillator
- cardiac pacemaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Manitoba Medical Service Foundationcollaborator
Study Sites (1)
Health Sciences Centre
Winnipeg, Manitoba, R3A1R9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Marcus Ng
- Organization
- University of Manitoba
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus Ng, MD
University of Manitoba
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2019
First Posted
January 28, 2019
Study Start
July 15, 2019
Primary Completion
November 30, 2020
Study Completion
August 31, 2021
Last Updated
February 16, 2023
Results First Posted
February 16, 2023
Record last verified: 2020-11