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NCT03819543: SURESTEP

SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus

Terminated NA Results posted Last updated 16 February 2023
What this trial tests

NA trial testing Transcranial Direct Current Stimulation in Status Epilepticus in 10 participants. Terminated before completion.

Timeline
15 July 2019
Primary endpoint
30 November 2020
31 August 2021

Quick facts

Lead sponsorUniversity of Manitoba
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date15 July 2019
Primary completion30 November 2020
Estimated completion31 August 2021
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Manitoba

Who can join

18 and older, any sex, with Status Epilepticus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Epileptiform Activity, Per Patient-based Primary · 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.

Pre-Stim Change (Automated Counts)
GroupValue95% CI
Transcranial Direct Current Stimulation-45.9-59 – -11.9
Pre-Stim Change (Human Counts)
GroupValue95% CI
Transcranial Direct Current Stimulation-51.6-70.2 – -17.9
Pre-Post Change (Automated Counts)
GroupValue95% CI
Transcranial Direct Current Stimulation-18.3-25.4 – -1.4
Pre-Post Change (Human Counts)
GroupValue95% CI
Transcranial Direct Current Stimulation-25.3-42.6 – -15.5
Frequency of Epileptiform Activity, Per-session Based Secondary · 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.

Pre-Stim Change (Automated Counts)
GroupValue95% CI
Transcranial Direct Current Stimulation-47.2-76.8 – -16.7
Pre-Stim Change (Human Counts)
GroupValue95% CI
Transcranial Direct Current Stimulation-38.5-79.7 – -4.7
Pre-Post Change (Automated Counts)
GroupValue95% CI
Transcranial Direct Current Stimulation-6.8-48.7 – 21.5
Pre-Post Change (Human Counts)
GroupValue95% CI
Transcranial Direct Current Stimulation-21.8-61.4 – 12.7

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Transcranial Direct Current Stimulation

Trials testing the same drug.

Other recruiting trials for Status Epilepticus

Currently open trials in the same condition.

Other University of Manitoba trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03819543.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing