Trial Outcomes & Findings for SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus (NCT NCT03819543)
NCT ID: NCT03819543
Last Updated: 2023-02-16
Results Overview
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.
TERMINATED
NA
10 participants
Up to 3 hours per EEG recording
2023-02-16
Participant Flow
Participant milestones
| Measure |
Transcranial Direct Current Stimulation
Patients receiving transcranial direct current stimulation
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Transcranial Direct Current Stimulation
n=10 Participants
Patients receiving transcranial direct current stimulation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 3 hours per EEG recordingPopulation: Automated and human counting methods found differing numbers of spikes between patients.
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.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=10 Participants
Patients receiving transcranial direct current stimulation
|
|---|---|
|
Frequency of Epileptiform Activity, Per Patient-based
Pre-Stim Change (Automated Counts)
|
-45.9 percentage reduction in spikes/sec
Interval -59.0 to -11.9
|
|
Frequency of Epileptiform Activity, Per Patient-based
Pre-Stim Change (Human Counts)
|
-51.6 percentage reduction in spikes/sec
Interval -70.2 to -17.9
|
|
Frequency of Epileptiform Activity, Per Patient-based
Pre-Post Change (Automated Counts)
|
-18.3 percentage reduction in spikes/sec
Interval -25.4 to -1.4
|
|
Frequency of Epileptiform Activity, Per Patient-based
Pre-Post Change (Human Counts)
|
-25.3 percentage reduction in spikes/sec
Interval -42.6 to -15.5
|
SECONDARY outcome
Timeframe: Up to 3 hours per EEG recordingPopulation: Automated and human counting methods found differing numbers of spikes between patients.
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.
Outcome measures
| Measure |
Transcranial Direct Current Stimulation
n=29 Sessions
Patients receiving transcranial direct current stimulation
|
|---|---|
|
Frequency of Epileptiform Activity, Per-session Based
Pre-Stim Change (Automated Counts)
|
-47.2 percentage reduction in spikes/sec
Interval -76.8 to -16.7
|
|
Frequency of Epileptiform Activity, Per-session Based
Pre-Stim Change (Human Counts)
|
-38.5 percentage reduction in spikes/sec
Interval -79.7 to -4.7
|
|
Frequency of Epileptiform Activity, Per-session Based
Pre-Post Change (Automated Counts)
|
-6.8 percentage reduction in spikes/sec
Interval -48.7 to 21.5
|
|
Frequency of Epileptiform Activity, Per-session Based
Pre-Post Change (Human Counts)
|
-21.8 percentage reduction in spikes/sec
Interval -61.4 to 12.7
|
Adverse Events
Transcranial Direct Current Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place