Trial · NCT06081283
Antiseizure Medication in Seizure Networks at Early Acute Brain Injury
NCT06081283, Phase 4, Terminated, University of North Carolina, Chapel Hill; results first posted 2025-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Antiseizure Medication in Seizure Networks at Early Acute Brain Injury. Trials, record NCT06081283. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06081283
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antiseizure Medication in Seizure Networks at Early Acute Brain Injury
- NCT number
- NCT06081283
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 5 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Brain Injuries, Acute, Brain Injuries, Traumatic, Brain Ischemia, Brain Hypoxia, Hypoxia-Ischemia, Brain, Heart Arrest, Stroke, Intracranial Hemorrhages, Coma, Persistent Vegetative State
- Interventions
- Phenobarbital Sodium Injection, Levetiracetam, Lacosamide Injectable Product, Valproate Sodium, Fosphenytoin
- First posted
- 2023-10-13
- Last updated
- 2025-11-14
- Results first posted
- 2025-11-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pre and Post-intervention Seizure Networks Power Spectrum Medians | At the time of the second study rs-fMRI scan, which acquisition can be from 3 to 13 days after the intervention start date. | Power spectral analysis identifies differences in Blood Oxygen Level Dependent (BOLD) changes between different cortical areas, cognitive states, or frequency bands that may reflect a pattern of component frequencies. The power spectrum graph shows the BOLD signal's power density over multiple frequencies, measured in Hz/100. Power Spectrum (PS) is the sum of the PS of the SzNET independent components normalized by their spatial volumes. Functional scans were co-registered to the anatomical T1 image, visually inspected, and subjected to independent component analysis (ICA) using the FMRIB Software Library (FSL) tool MELODIC. ICA was applied to separate the BOLD signal into independent components generated by brain networks, which were evaluated for suspected seizure onset zones (SOZs) based on spatial and temporal features. Pre- and post-intervention Rs-fMRI medians were found from the normalized and volume-adjusted area under the curve of the SzNET PS curve above 6.78 Hz/100. |
| Primary | Pre and Post-intervention Seizure Networks Total Volume Medians | At the time of the second study rs-fMRI scan, which acquisition can be from 3 to 13 days after the intervention start date. | Rs-fMRI data is collected as 2 runs of 10-minute data collection on a 3T MRI scanner. One volume from the fMRI is a complete slice of the brain's activity at a specific point of time. Over the 20-minute period that the rs-fMRI is performed, many volumes are collected at different time points continuously throughout the scan. These volume elements are measured in units of voxels which are a 3D unit of the MRI image. SzNET total volume (TV) is the sum of the volumes of the SzNET independent components, collected through ICA where independent components generated by brain networks were evaluated for suspected seizure onset zones. The medians from the normalized volume of the total seizure networks, of both pre and post-intervention rs-fMRI, were collected from this data. |
| Secondary | Presence of Seizure Networks in the First Resting State Functional MRI | At the time of the first study rs-fMRI scan, which acquisition can be from 1 to 3 days after enrollment. | Binary Variable. The total amount of participants for this outcome measure will include only the subjects enrolled until the first sampling quota is completed. Only the two SzNET+ groups have a minimum enrollment goal. Thus, enrollment will stop once each of the two SzNET+ groups enroll ten patients. |
| Secondary | Follow-up Electroencephalogram Improvement | At the time of the follow-up study EEG, which acquisition can be from 3 to 13 days after the intervention start date. | Binary variable categorized as "with improvement" or "without improvement", obtained by expert's overall qualitative assessment comparing the follow-up study EEG and the clinically indicated EEG considered at the enrollment time. The qualitative assessment will be based on the EEG's background and the presence of electrophysiological signs of ictal or interictal activity. These signs are described by the American Clinical Neurophysiology Society as: Epileptiform Discharges Rhythmic and periodic patterns; Electrographic and electroclinical seizures; and Ictal-interictal continuum. |
| Secondary | Connectivity Improvement of Typical Resting State Networks After Intervention | At the time of the second study rs-fMRI scan, which acquisition can be from 3 to 13 days after the intervention start date. | Binary variable obtained by expert's opinion comparison between the typical resting state networks of the pre and post-intervention resting state functional MRIs |
| Secondary | Enrollment Rate | The day of enrollment of each patient, and this will be collected through study completion, a duration of 1 year | Number of participants enrolled divided by the amount of eligible participants screened. |
| Secondary | Dropout Rate | from enrollment to the second rs-fMRI acquisition time limit which means from 0 to 19 days from enrollment. | Number of dropout participants divided by the amount of enrolled participants. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pre and Post-intervention Seizure Networks Power Spectrum Medians | At the time of the second study rs-fMRI scan, which acquisition can be from 3 to 13 days after the intervention start date. | This outcome does not apply to the Seizure Network Negative Subjects; therefore, no data were collected for this group. | Hz/10^2 | MEDIAN |
| PRIMARY | Pre and Post-intervention Seizure Networks Total Volume Medians | At the time of the second study rs-fMRI scan, which acquisition can be from 3 to 13 days after the intervention start date. | This outcome does not apply to the Seizure Network Negative Subjects; therefore, no data were collected for this group. | voxels | MEDIAN |
| SECONDARY | Presence of Seizure Networks in the First Resting State Functional MRI | At the time of the first study rs-fMRI scan, which acquisition can be from 1 to 3 days after enrollment. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Follow-up Electroencephalogram Improvement | At the time of the follow-up study EEG, which acquisition can be from 3 to 13 days after the intervention start date. | Follow-up EEG activity only includes Seizure Network Positive Subjects; therefore, no data were collected for the Seizure Network Negative Subjects arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Connectivity Improvement of Typical Resting State Networks After Intervention | At the time of the second study rs-fMRI scan, which acquisition can be from 3 to 13 days after the intervention start date. | Connectivity of typical resting state networks only includes Seizure Network Positive Subjects; therefore, no data were collected for the Seizure Network Negative Subjects arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Enrollment Rate | The day of enrollment of each patient, and this will be collected through study completion, a duration of 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Dropout Rate | from enrollment to the second rs-fMRI acquisition time limit which means from 0 to 19 days from enrollment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pre and Post-intervention Seizure Networks Power Spectrum Medians | Seizure Network Positive Subjects | Pre-intervention rs-fMRI | 1.66 | Full Range -0.45 to 3.46 | Hz/10^2 |
| Pre and Post-intervention Seizure Networks Power Spectrum Medians | Seizure Network Positive Subjects | Post-intervention rs-fMRI | 0.061 | Full Range 0.049 to 3.43 | Hz/10^2 |
| Pre and Post-intervention Seizure Networks Total Volume Medians | Seizure Network Positive Subjects | Pre-intervention rs-fMRI | 3733.89 | Full Range 3095.17 to 6378.14 | voxels |
| Pre and Post-intervention Seizure Networks Total Volume Medians | Seizure Network Positive Subjects | Post-intervention rs-fMRI | 3734.00 | Full Range 3095.00 to 6378.00 | voxels |
| Presence of Seizure Networks in the First Resting State Functional MRI | Seizure Network Positive Subjects | Seizure networks present | 3 | Participants | |
| Presence of Seizure Networks in the First Resting State Functional MRI | Seizure Network Negative Subjects | Seizure networks present | 0 | Participants | |
| Presence of Seizure Networks in the First Resting State Functional MRI | Seizure Network Positive Subjects | Seizure networks absent | 0 | Participants | |
| Presence of Seizure Networks in the First Resting State Functional MRI | Seizure Network Negative Subjects | Seizure networks absent | 2 | Participants | |
| Follow-up Electroencephalogram Improvement | Seizure Network Positive Subjects | With improvement | 0 | Participants | |
| Follow-up Electroencephalogram Improvement | Seizure Network Positive Subjects | Without improvement | 3 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Seizure Network Positive Subjects | 3 | |
| Overall Study | STARTED | Seizure Network Negative Subjects | 2 | |
| Overall Study | Received Initial Phenobarbital Sodium Followed by Lacosamide | Seizure Network Positive Subjects | 1 | |
| Overall Study | Received Initial Phenobarbital Sodium Followed by Lacosamide | Seizure Network Negative Subjects | 0 | |
| Overall Study | Completed Initial Phenobarbital Sodium Followed by Lacosamide | Seizure Network Positive Subjects | 1 | |
| Overall Study | Completed Initial Phenobarbital Sodium Followed by Lacosamide | Seizure Network Negative Subjects | 0 | |
| Overall Study | Received Initial Levetiracetam Followed by Lacosamide | Seizure Network Positive Subjects | 2 | |
| Overall Study | Received Initial Levetiracetam Followed by Lacosamide | Seizure Network Negative Subjects | 0 | |
| Overall Study | Completed Initial Levetiracetam Followed by Lacosamide | Seizure Network Positive Subjects | 2 | |
| Overall Study | Completed Initial Levetiracetam Followed by Lacosamide | Seizure Network Negative Subjects | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Seizure Network Positive Subjects | 1 | 3 |
| Total, all-cause mortality | Seizure Network Negative Subjects | 2 | 2 |
| Total, other adverse events | Seizure Network Positive Subjects | 0 | 3 |
| Total, other adverse events | Seizure Network Negative Subjects | 0 | 0 |
| Total, serious adverse events | Seizure Network Positive Subjects | 0 | 3 |
| Total, serious adverse events | Seizure Network Negative Subjects | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Seizure Network Positive Subjects vs Seizure Network Negative Subjects: Dropout Rate | Trial comparisons |
| Seizure Network Positive Subjects vs Seizure Network Negative Subjects: deaths from any cause | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06081283
GET https://conductscience.org/api/trials/v1/NCT06081283/registered