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Swiss SOS MoCA - DCI Study
Recruiting
Trial ID: NCT03032471
Purpose
The primary objective of this multicenter observational study is to determine the effect size
of the relationship between DCI and neuropsychological impairment 14-28 days and 3 months
after aSAH.
Secondary objectives are the feasibility to administer and the validity of the MoCA in an
intensive care unit setting, as well as the test/retest reliability of the MoCA in patients
with acute brain damage in absence of aSAH.
Official Title
Impact of Delayed Cerebral Ischemia (DCI) on the Neuropsychological Outcome After Aneurysmal Subarachnoid Hemorrhage - a SWISS SOS Multicentre Observational Study
Eligibility
Inclusion Criteria:
For part 1 of the study:
Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Consent of the patient or consent of patient's next of kin (plus consent of an
independent physician if patient is unable to consent)
- Aneurysmal SAH
- Age: ≥18
- Time of aSAH known (IMPORTANT: at least approximated. Time of aSAH refers to the bleed
that lead to hospital admission; warning leaks in the patient history are not
considered aSAH in this context)
- Complete aneurysm occlusion therapy within 48h after aSAH
- Glasgow coma scale (GCS) ≥ 13 points at time point 48h - 72h after aSAH
- Fluent language skills in either English, German, French, or Italian
For part 2 of the study:
Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Consent of the patient or consent of patient's next of kin (plus consent of an
independent physician if patient is unable to consent)
- Age: ≥18
- Acute brain injury that requires a in-patient treatment, e.g. for (surgical) treatment
of a brain tumor, a cerebral hemorrhage, a hydrocephalus, stroke, or traumatic brain
injury, with stable neurological and general health status
- Glasgow coma scale (GCS) ≥ 13 points
- Fluent language skills in either English, German, French, or Italian
Exclusion Criteria:
For part 1 of the study:
The presence of any one of the following exclusion criteria will lead to exclusion of the
participant:
- SAH due to any other cause than aneurysm or structural abnormality of the brain
(arterio-venous malformation, dural arterio-venous fistula, cavernous malformation,
dissection, tumor, trauma)
- Comatose patients or patients with a reduced vigilance of GCS < 13 at time point 48h -
72h after aSAH
- No aneurysm occlusion therapy within 48h after aSAH
- Clear signs of arterial vasospasm in the initial (CT-)angiography; indicating that
aSAH had occurred already several days prior to admission
- Neurologic or psychiatric diseases other than aSAH that can potentially influence the
test-performance of a patient on the MoCA (e.g., dementia, multiple sclerosis, bipolar
disorder)
- Foreseeable difficulties in follow-up due to geographic reasons (e.g., patients living
abroad)
- Patients who are not fluent in English, German, French, or Italian
- Patients requiring sedative or other medication that would interfere with the
neuropsychological evaluation
For part 2 of the study:
The presence of any one of the following exclusion criteria will lead to exclusion of the
participant:
- Instable neurological or general health-status of the patient, that makes a transport
of the patient on the ICU or the office for neuropsychological testing impossible
- Suspected fluctuation of the neurological condition and the vigilance of the patient
between first and second testing
- Known psychiatric disease that can potentially influence the test-performance on the
MoCA (e.g., dementia, bipolar disorder)
- Patients who are not fluent in English, German, French, or Italian
- Patients requiring sedative or other medication that would interfere with the
neuropsychological evaluation
Intervention(s):
other: There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305