NCT05851391

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
10mo left

Started Aug 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Aug 2023Apr 2027

First Submitted

Initial submission to the registry

February 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 7, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

3.3 years

First QC Date

February 24, 2023

Last Update Submit

May 12, 2025

Conditions

Hypoxia-Ischemia, BrainHeart ArrestStatus EpilepticusRefractory Status EpilepticusSeizuresAnoxic-Ischemic EncephalopathyAnoxia-Ischemia, Cerebral

Outcome Measures

Primary Outcomes (1)

  • 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)

    48 hours

Secondary Outcomes (10)

  • Seizure recurrence incidence and duration (burden)

    24-48 hours

  • Neurological Function at Discharge (CPC: Cerebral Performance Category)

    30 days

  • Neurological Function at Discharge (mRS: modified Ranking Scale)

    30 days

  • Neurological Function 90 days (CPC: Cerebral Performance Category)

    90 days

  • Neurological Function 90 days (mRS: modified Ranking Scale)

    90 days

  • +5 more secondary outcomes

Study Arms (2)

Burst Suppression EEG Target

OTHER

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

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.

Drug: Seizure Suppression EEG Target Intravenous Anesthesia

Interventions

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.

Burst Suppression EEG Target
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.

Seizure Suppression EEG Target

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Acute cerebral hemorrhage or infarction
  • Pregnancy
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, BrainHeart ArrestStatus EpilepticusSeizures

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesNeurologic Manifestations

Study Officials

  • Edilberto Amorim, MD

    Assistant Professor of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edilberto Amorim, MD

CONTACT

628-206-3203restorestudy@ucsf.edu

Kevin Bao

CONTACT

(415)514-2120restorestudy@ucsf.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2023

First Posted

May 9, 2023

Study Start

August 7, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)