Trial Summary
What is the purpose of this trial?The purpose of the study is to see that in addition to existing therapy, how well an additional procedure named spinal cord stimulation might reduce blood vessel spasm from aneurysm rupture.
Eligibility Criteria
This trial is for adults who've had a specific type of brain bleed (Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage) and can have endovascular treatment. They must consent to all study procedures, be available throughout the study, and women must not be pregnant. It's not for those with posterior circulation bleeds, treated after day 1 of bleeding, unwilling to consent, or too ill for the procedure.Inclusion Criteria
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
I have been diagnosed with a severe brain hemorrhage.
+3 more
Exclusion Criteria
I had a bleeding in the brain from an aneurysm in the back part of my brain.
My aneurysm treatment started after the first day of bleeding.
Does not provide consent for the procedure
+1 more
Participant Groups
The trial tests if spinal cord stimulation (Vectris leads and stimulation), along with standard care, helps reduce blood vessel spasms in the brain following an aneurysm rupture compared to a sham (fake) procedure.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Spinal Cord StimulationExperimental Treatment1 Intervention
Participants randomized to receive temporary electrode inserted through the skin into the epidural space of participants upper back/lower neck.
Group II: Sham ComparatorPlacebo Group1 Intervention
Participants randomized to not receive temporary electrode.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor