Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT05150002
Eligibility Criteria:
Inclusion Criteria:
* Fisher 3 grade subarachnoid hemorrhage at presentation
* Secured aneurysm by clipping or coiling
* Is 18-75 years of age at the time of enrollment
* Cerebral vasospasm:
* Cerebral angiography
o Narrowing of vessel lumen \> 66%
* Transcranial Doppler ultrasound
* Mean flow velocity \> 150 cm/s or
* Lindegaard Index \> 3 or
* increase \> 50 cm/s within 24 hours
* Intracranial CT angiography
o Narrowing of vessel lumen \> 66%
* Intracranial CT perfusion o Time To Drain (TTD) \> 4.7 seconds
* Is willing and capable of providing informed consent or existence of the presumed will of the patient by a relative or a legal representative
* Written confirmation by a study independent physician to guarantee patient interest
* Is willing and capable of complying with the study related requirements, procedures, and visits
* No findings on spinal imaging preventing SCS lead implantation
* Negative pregnancy test
* No breast feeding
Exclusion Criteria:
* Untreated ruptured aneurysm
* Cerebral infarction in the territory of the spastic arteries or massive disseminated infarction
* Signs of cerebral herniation
* Uncontrollable intracranial pressure
* Infection
* Coagulation disorder
* Is participating in another interventional trial
* Circulatory instability
* Severe congestive heart failure
* Patients with an elevated risk of bleeding
* Known allergy to implanted materials (Silicon, Titanium)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05150002
Study Brief:
Protocol Section:
NCT05150002