Recruiting
Phase 2

buRst-supprESsion

Sponsor:

UCLA

Code:

NCT05851391

Conditions

Hypoxia-Ischemia, Brain

Heart Arrest

Status Epilepticus

Refractory Status Epilepticus

Seizures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Burst Suppression EEG Target Intravenous Anesthesia

Seizure Suppression EEG Target Intravenous Anesthesia

Study Details

Brief 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.

Conditions

Hypoxia-Ischemia, Brain

Heart Arrest

Status Epilepticus

Refractory Status Epilepticus

Seizures

Study ID

NCT05851391

Start date

Aug 7, 2023

Status verified date

Jul, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥18 years old
2. Non-traumatic, out-of-hospital cardiac arrest
3. Comatose on admission - defined as not following commands
4. Return of spontaneous circulation (ROSC) within less than 45 minutes
5. Admission to the intensive care unit
6. Diagnosis of post-cardiac arrest refractory status epilepticus confirmed with continuous

EEG monitoring within 7 days from ROSC

Exclusion Criteria:

1. Acute cerebral hemorrhage or infarction
2. Pregnancy
3. Prisoners

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Burst Suppression EEG Target

Anesthetic will be titrated to achieve burst suppression on continuous EEG (50-99% attenuation/suppression) for 24 hours.

other: Seizure Suppression EEG Target

Anesthetic will be titrated to achieve seizure suppression on continuous EEG for 24 hours.

Interventions

Burst Suppression EEG Target Intravenous Anesthesia

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 Anesthesia

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.

Primary outcome measure

  • Post-cardiac arrest refractory status epilepticus control [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Edilberto Amorim, MD

628-206-3203restorestudy@ucsf.edu

Kevin Bao

(415)514-2120restorestudy@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-29.