Hypoxia-Ischemia, BrainPhase 2RESTORENCT05851391
buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest
A Phase 2 study testing Burst Suppression EEG Target Intravenous Anesthesia and Seizure Suppression EEG Target Intravenous Anesthesia in people with Hypoxia-Ischemia, Brain and Heart Arrest, run by University of California, San Francisco at 1 site in United States.
Trial summary
RESTORE is a randomized clinical trial investigating the safety and feasibility of using EEG treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia-Ischemia, Brain, Heart Arrest, Status Epilepticus
- What is being tested?
- Burst Suppression EEG Target Intravenous Anesthesia and Seizure Suppression EEG Target Intravenous Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 30 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Non-traumatic, out-of-hospital cardiac arrest
- Comatose on admission - defined as not following commands
- Return of spontaneous circulation (ROSC) within less than 45 minutes
- Admission to the intensive care unit
- Diagnosis of post-cardiac arrest refractory status epilepticus confirmed with continuous
- EEG monitoring within 7 days from ROSC
Who cannot join
- Acute cerebral hemorrhage or infarction
- Pregnancy
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Edilberto Amorim, MD
About this study
Official title: buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest (RESTORE)
RESTORE is a randomized clinical trial investigating the safety and feasibility of using EEG treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment.
Read the detailed description
Rationale: Seizures emerge as a complication of hypoxic-ischemic brain injury in near a third of patients successfully resuscitated from cardiac arrest. Seizures post-cardiac arrest can be refractory to treatment with anti-seizure medications and anesthetics may be used for refractory status epilepticus control. Anesthetic treatment guided by continuous EEG can target burst suppression or seizure suppression, however it is not known which strategy is superior for achieving PCARSE control.
Objective: determine the safety and feasibility of post-cardiac arrest refractory status epilepticus (PCARSE) treatment using EEG goals for intravenous anesthetic titration (burst suppression vs. seizure suppression).
Clinical Trial Phase: II
Study Design: prospective, randomized, open-label, blinded end-point, concurrently-controlled, parallel arms design clinical trial.
Study Period: two years
Study Population: unconscious cardiac arrest survivors with return of spontaneous circulation who develop post-cardiac arrest refractory status epilepticus (PCARSE).
Interventions: anesthetic use targeting burst suppression vs. seizure suppression on EEG for 24 hours. Intervention maybe repeated using the dame EEG target once in case of PCARSE recurrence.
Sample Size: 30 subjects randomized in a 1:1 ratio to either burst suppression or seizure suppression EEG targets.
Primary Endpoints: Safety and feasibility of seizure control using burst suppression or seizure suppression EEG targets for PCARSE treatment.
Secondary Endpoints: Seizure recurrence incidence, time to seizure recurrence, number and dose of anti-seizure medication and anesthetic needed for PCARSE control, Death or disability according to the Cerebral Performance Category at Discharge (30 days), and Death or disability according to the modified Rankin Scale at Discharge (30 days).
Risks: Participants receiving anesthetics for PCARSE treatment will be monitored for hypotension, propofol infusion syndrome, and hypertriglyceridemia. Patients with PCARSE are at high risk for death and prolonged hospital stays.
- Conditions
- Hypoxia-Ischemia, Brain, Heart Arrest, Status Epilepticus, Refractory Status Epilepticus, Seizures, Anoxic-Ischemic Encephalopathy
- Being tested
- Burst Suppression EEG Target Intravenous Anesthesia, Seizure Suppression EEG Target Intravenous Anesthesia
- Medical subject headings
- Hypoxia-Ischemia, Brain, Heart Arrest, Status Epilepticus, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burst Suppression EEG Target Intravenous AnesthesiaDrug
The objective of the burst suppression EEG target is to stop seizures by titrating the anesthetic infusion to suppress most of the EEG background (>50% suppressed/attenuated). After this 24-hour period, this target would be continued for 24 hours. The anesthetic will then be tapered under EEG monitoring. In case of PCARSE recurrence, the intervention with the same target will be re-initiated for another cycle of 24 hours.
Seizure Suppression EEG Target Intravenous AnesthesiaDrug
is to stop seizures by titrating the anesthetic infusion without suppressing most of the EEG background. This target would be continued for 24 hours. After this 24-hours period, this target would be continued for 24 hours. The anesthetic will then be tapered under EEG monitoring. In case of PCARSE recurrence, the intervention with the same target will be re-initiated for another cycle of 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Burst Suppression EEG Target | Other | Anesthetic will be titrated to achieve burst suppression on continuous EEG (50-99% attenuation/suppression) for 24 hours. Receives: Drug: Burst Suppression EEG Target Intravenous Anesthesia |
| Seizure Suppression EEG Target | Other | Anesthetic will be titrated to achieve seizure suppression on continuous EEG for 24 hours. Receives: Drug: Seizure Suppression EEG Target Intravenous Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-cardiac arrest refractory status epilepticus control
Continuous EEG will be monitored to determine time to PCARSE recurrence during the anesthetic maintenance and anesthetic weaning phase (combined)
Measured: 48 hours
Secondary outcomes (10)
Seizure recurrence incidence and duration (burden)
Presence of seizures on EEG after initiation of anesthetic maintenance phase
Measured: 24-48 hours
Neurological Function at Discharge (CPC: Cerebral Performance Category)
Cerebral Performance Category score at Discharge
Measured: 30 days
Neurological Function at Discharge (mRS: modified Ranking Scale)
modified Rankin Scale score at Discharge
Measured: 30 days
Neurological Function 90 days (CPC: Cerebral Performance Category)
Cerebral Performance Category score at 90 days
Measured: 90 days
Neurological Function 90 days (mRS: modified Ranking Scale)
modified Rankin Scale score at Discharge
Measured: 90 days
Neurological Function 180 days (mRS: modified Ranking Scale)
modified Rankin Scale score at Discharge
Measured: 180 days
Neurological Function180 days (mRS: modified Ranking Scale)
modified Rankin Scale score at Discharge
Measured: 180 days
PCARSE Treatment Intensity
Number of anti-seizure medications and anesthetics used for PCARSE control after initiation of anesthetic maintenance phase and prior to weaning
Measured: 24-48 hours
Seizure recurrence incidence and duration (burden)
Presence of seizures on EEG after initiation of anesthetic weaning phase
Measured: 24-48 hours
PCARSE Treatment Intensity
Dose of anti-seizure medications and anesthetics used for PCARSE control after initiation of anesthetic maintenance phase and prior to weaning
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start7 Aug 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia-Ischemia, BrainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- The ZOLL Foundation
- Responsible party
- Sponsor
- Investigators
- Edilberto Amorim, MD, Principal investigator, Assistant Professor of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851391
- Sponsor's protocol ID
- 21-34336
- Acronym
- RESTORE
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest (RESTORE)
- ClinicalTrials.gov ID
- NCT05851391
- Acronym / sponsor ID
- RESTORE / 21-34336
- Conditions
- Hypoxia-Ischemia, Brain, Heart Arrest, Status Epilepticus, Refractory Status Epilepticus, Seizures, Anoxic-Ischemic Encephalopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- The ZOLL Foundation
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RESTORE is a randomized clinical trial investigating the safety and feasibility of using EEG treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment.
Detailed description
Rationale: Seizures emerge as a complication of hypoxic-ischemic brain injury in near a third of patients successfully resuscitated from cardiac arrest. Seizures post-cardiac arrest can be refractory to treatment with anti-seizure medications and anesthetics may be used for refractory status epilepticus control. Anesthetic treatment guided by continuous EEG can target burst suppression or seizure suppression, however it is not known which strategy is superior for achieving PCARSE control.
Objective: determine the safety and feasibility of post-cardiac arrest refractory status epilepticus (PCARSE) treatment using EEG goals for intravenous anesthetic titration (burst suppression vs. seizure suppression).
Clinical Trial Phase: II
Study Design: prospective, randomized, open-label, blinded end-point, concurrently-controlled, parallel arms design clinical trial.
Study Period: two years
Study Population: unconscious cardiac arrest survivors with return of spontaneous circulation who develop post-cardiac arrest refractory status epilepticus (PCARSE).
Interventions: anesthetic use targeting burst suppression vs. seizure suppression on EEG for 24 hours. Intervention maybe repeated using the dame EEG target once in case of PCARSE recurrence.
Sample Size: 30 subjects randomized in a 1:1 ratio to either burst suppression or seizure suppression EEG targets.
Primary Endpoints: Safety and feasibility of seizure control using burst suppression or seizure suppression EEG targets for PCARSE treatment.
Secondary Endpoints: Seizure recurrence incidence, time to seizure recurrence, number and dose of anti-seizure medication and anesthetic needed for PCARSE control, Death or disability according to the Cerebral Performance Category at Discharge (30 days), and Death or disability according to the modified Rankin Scale at Discharge (30 days).
Risks: Participants receiving anesthetics for PCARSE treatment will be monitored for hypotension, propofol infusion syndrome, and hypertriglyceridemia. Patients with PCARSE are at high risk for death and prolonged hospital stays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burst Suppression EEG Target | Other | Drug: Burst Suppression EEG Target Intravenous AnesthesiaAnesthetic will be titrated to achieve burst suppression on continuous EEG (50-99% attenuation/suppression) for 24 hours. |
| Seizure Suppression EEG Target | Other | Drug: Seizure Suppression EEG Target Intravenous AnesthesiaAnesthetic will be titrated to achieve seizure suppression on continuous EEG for 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years old
- Non-traumatic, out-of-hospital cardiac arrest
- Comatose on admission - defined as not following commands
- Return of spontaneous circulation (ROSC) within less than 45 minutes
- Admission to the intensive care unit
Key exclusion criteria (3 listed)
- Acute cerebral hemorrhage or infarction
- Pregnancy
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Burst Suppression EEG Target Intravenous AnesthesiaThe objective of the burst suppression EEG target is to stop seizures by titrating the anesthetic infusion to suppress most of the EEG background (>50% suppressed/attenuated). After this 24-hour period, this target would be continued for 24 hours. The anesthetic will then be tapered under EEG monitoring. In case of PCARSE recurrence, the intervention with the same target will be re-initiated for another cycle of 24 hours. | Drug | Burst Suppression EEG Target |
| Seizure Suppression EEG Target Intravenous Anesthesiais to stop seizures by titrating the anesthetic infusion without suppressing most of the EEG background. This target would be continued for 24 hours. After this 24-hours period, this target would be continued for 24 hours. The anesthetic will then be tapered under EEG monitoring. In case of PCARSE recurrence, the intervention with the same target will be re-initiated for another cycle of 24 hours. | Drug | Seizure Suppression EEG Target |
Primary outcome
Post-cardiac arrest refractory status epilepticus control
Time frame: 48 hours
Continuous EEG will be monitored to determine time to PCARSE recurrence during the anesthetic maintenance and anesthetic weaning phase (combined)
10 secondary outcomes
Seizure recurrence incidence and duration (burden)
Time frame: 24-48 hours
Neurological Function at Discharge (CPC: Cerebral Performance Category)
Time frame: 30 days
Neurological Function at Discharge (mRS: modified Ranking Scale)
Time frame: 30 days
Neurological Function 90 days (CPC: Cerebral Performance Category)
Time frame: 90 days
Neurological Function 90 days (mRS: modified Ranking Scale)
Time frame: 90 days
Neurological Function 180 days (mRS: modified Ranking Scale)
Time frame: 180 days
Neurological Function180 days (mRS: modified Ranking Scale)
Time frame: 180 days
PCARSE Treatment Intensity
Time frame: 24-48 hours
Seizure recurrence incidence and duration (burden)
Time frame: 24-48 hours
PCARSE Treatment Intensity
Time frame: 24-48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edilberto Amorim, MD principal investigator
Assistant Professor of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Burst Suppression EEG Target Intravenous Anesthesia and Seizure Suppression EEG Target Intravenous Anesthesia in people with Hypoxia-Ischemia, Brain and Heart Arrest, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edilberto Amorim, MD (628-206-3203, restorestudy@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-cardiac arrest refractory status epilepticus control (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.