Status Epilepticus
Conditions
Brief summary
The purpose of this study is to determine whether transcranial direct current stimulation affects super refractory status epilepticus.
Interventions
DEVICETranscranial Direct Current Stimulation
Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA.
Sponsors
Manitoba Medical Service Foundation
University of Manitoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Direct Current Stimulation Patients receiving transcranial direct current stimulation | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Transcranial Direct Current Stimulation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 8 Participants | — |
| Age, Categorical Between 18 and 65 years | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: Up to 3 hours per EEG recording
Population: Automated and human counting methods found differing numbers of spikes between patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Frequency of Epileptiform Activity, Per Patient-based | Pre-Stim Change (Automated Counts) | -45.9 percentage reduction in spikes/sec |
| Transcranial Direct Current Stimulation | Frequency of Epileptiform Activity, Per Patient-based | Pre-Stim Change (Human Counts) | -51.6 percentage reduction in spikes/sec |
| Transcranial Direct Current Stimulation | Frequency of Epileptiform Activity, Per Patient-based | Pre-Post Change (Automated Counts) | -18.3 percentage reduction in spikes/sec |
| Transcranial Direct Current Stimulation | Frequency of Epileptiform Activity, Per Patient-based | Pre-Post Change (Human Counts) | -25.3 percentage reduction in spikes/sec |
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.
Time frame: Up to 3 hours per EEG recording
Population: Automated and human counting methods found differing numbers of spikes between patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Frequency of Epileptiform Activity, Per-session Based | Pre-Stim Change (Automated Counts) | -47.2 percentage reduction in spikes/sec |
| Transcranial Direct Current Stimulation | Frequency of Epileptiform Activity, Per-session Based | Pre-Stim Change (Human Counts) | -38.5 percentage reduction in spikes/sec |
| Transcranial Direct Current Stimulation | Frequency of Epileptiform Activity, Per-session Based | Pre-Post Change (Automated Counts) | -6.8 percentage reduction in spikes/sec |
| Transcranial Direct Current Stimulation | Frequency of Epileptiform Activity, Per-session Based | Pre-Post Change (Human Counts) | -21.8 percentage reduction in spikes/sec |