SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus

Status Epilepticus Clinical Trial

— SURESTEP  

Official title:

Transcranial Direct Current Stimulation in SUper REfractory STatus EPilepticus (SURESTEP): Pilot Study of a Novel Therapy in a Common Medical Emergency

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03819543
• Other study ID #: B2018:133
• Status: Terminated
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2020
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 31, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Status Epilepticus

Intervention

Device:
• Transcranial Direct Current Stimulation
Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA.

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Medical Service Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 3 hours per EEG recording