SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus

Not Applicable

Terminated

• Conditions: Status Epilepticus
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT03819543
• Lead Sponsor: University of Manitoba

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-28
• Study Start: 2019-07-15
• Status Verified: 2020-11
• Primary Completion: 2020-11-30
• Study Completion: 2021-08-31
• Results First Submitted: 2022-11-01
• Results First Submitted QC: 2023-01-19
• Last Update Submitted: 2023-01-19
• Results First Posted: 2023-02-16
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcranial Direct Current Stimulation	Transcranial Direct Current Stimulation	-

Primary Outcome Measures

Name	Time	Method
Frequency of Epileptiform Activity, Per Patient-based	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of Epileptiform Activity, Per-session Based	Up to 3 hours per EEG recording	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.

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada