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SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus (SURESTEP)

Primary Purpose

Status Epilepticus

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Epilepticus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of super refractory status epilepticus
  • admitted to the intensive care unit
  • identifiable epileptogenic focus on EEG

Exclusion Criteria:

  • 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

Sites / Locations

  • Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Direct Current Stimulation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 21, 2019
Last Updated
January 19, 2023
Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03819543
Brief Title
SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus
Acronym
SURESTEP
Official Title
Transcranial Direct Current Stimulation in SUper REfractory STatus EPilepticus (SURESTEP): Pilot Study of a Novel Therapy in a Common Medical Emergency
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether transcranial direct current stimulation affects super refractory status epilepticus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA.
Primary Outcome Measure Information:
Title
Frequency of Epileptiform Activity, Per Patient-based
Description
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.
Time Frame
Up to 3 hours per EEG recording
Secondary Outcome Measure Information:
Title
Frequency of Epileptiform Activity, Per-session Based
Description
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.
Time Frame
Up to 3 hours per EEG recording

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of super refractory status epilepticus admitted to the intensive care unit identifiable epileptogenic focus on EEG Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Ng, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A1R9
Country
Canada

12. IPD Sharing Statement

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SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus

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