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COVID-19
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| Name | Class |
|---|---|
| Manitoba Medical Service Foundation | OTHER |
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The purpose of this study is to determine whether transcranial direct current stimulation affects super refractory status epilepticus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Direct Current Stimulation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Device | Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Ng, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre | Winnipeg | Manitoba | R3A1R9 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Direct Current Stimulation | Patients receiving transcranial direct current stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Direct Current Stimulation | Patients receiving transcranial direct current stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Automated and human counting methods found differing numbers of spikes between patients. | Posted | Median | Inter-Quartile Range | percentage reduction in spikes/sec | Up to 3 hours per EEG recording |
|
|
through study completion, an average of 251.1 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Direct Current Stimulation | Transcranial Direct Current Stimulation: Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marcus Ng | University of Manitoba | 204-787-2684 | marcus.ng@umanitoba.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2019 | Oct 31, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Participants |
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|
| 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. | Automated and human counting methods found differing numbers of spikes between patients. | Posted | Median | Inter-Quartile Range | percentage reduction in spikes/sec | Up to 3 hours per EEG recording | Sessions | Sessions |
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| 7 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| Pre-Stim Change (Human Counts) |
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| Pre-Post Change (Automated Counts) |
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| Pre-Post Change (Human Counts) |
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