Swiss SOS MoCA - DCI Study

Swiss SOS Study Group

Status: Terminated

Conditions: Subarachnoid Hemorrhage; Cognitive Impairment; Complication; Stroke; Cognitive Deterioration; Cognitive Deficits Following Cerebral Infarction; Delayed Cerebral Ischemia; Cognitive Deficit

Treatments: Other: There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.

Study type: Observational

Funder types: Other

Identifiers

NCT03032471

2017_MST_01

Details and patient eligibility

About

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.

Full description

Background and rationale:

Delayed cerebral ischemia (DCI) is the independent most important predictor of neurological disability in survivors following aneurysmal subarachnoid hemorrhage (aSAH). DCI could also be identified as the most important predictor of moderate to severe neuropsychological impairment following aSAH. Only few prospective studies so far specifically analyzed the effect size of the relationship between DCI and neuropsychological impairment, and all studies had a methodological weakness: lack of a baseline neuropsychological assessment before the onset of DCI.

In studies analyzing the neuropsychological outcome after aSAH, the Montreal Cognitive Assessment (MoCA) is the most comprehensive, sensitive and specific instrument among the short tests. The MoCA is increasingly used in the aSAH population, while its validity and reliability has only been demonstrated in the normal population or patients suffering from diseases different from aSAH, such as e.g. Parkinson's disease or dementia. Today, neuropsychological examinations find entry into clinical routine for aSAH patients to estimate the need for inpatient rehabilitation. However, the MoCA is often applied to aSAH patients in a busy intensive or intermediate care unit, while it remains largely unknown whether the distraction in such an environment represents a bias to the obtained results.

This study therefore evaluates aSAH patients before and after the phase of DCI, as well as three months after aSAH, in order to estimate the impact of DCI on neuropsychological impairment. In addition, the extent and location of cerebral ischemia, as measured with the Alberta Stroke Program Early CT Score (ASPECTS) is correlated with the neuropsychological outcome.

Furthermore, the study measures the test/retest reliability of the MoCA, as well as the influence of the intensive care environment on the MoCA results in a randomized fashion in subjects with acute brain damage (and no aSAH).

Objectives:

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.

Outcomes:

The primary endpoint is the proportion of patients with or without DCI that show worsening on the MoCA 3 months after the ictus as compared to before the DCI phase by at least two points.

Key secondary endpoints for part 1 of the study are:

• The proportion of patients with or without DCI that show worsening on the MoCA 14-28 days after the ictus as compared to before the DCI phase by at least two points.
• The absolute difference of the MoCA before and after the active phase of DCI in patients with versus without DCI.
• The absolute difference of the MoCA before the active phase of DCI and 3 months after aSAH in patients with versus without DCI
• The rate of patients with versus without DCI that show cognitive impairment at 14-28 days and 3 months (defined as MoCA < 26 points)
• The correlation of neuropsychological outcome with the extent and location of ischemic lesions on brain CT-scan 12-21 days post-SAH, graded by the semi-quantitative ASPECT-grading
• Health-related quality of life at 3 months in patients with versus without DCI
• Home-time at 3 months in patients with versus without DCI
• Death and dependency at 3 months in patients with versus without DCI
• The absolute MoCA result, health-related quality of life and home-time at 3 months in patients with versus without hydrocephalus requiring shunting
• The absolute MoCA result, health-related quality of life and home-time at 3 months in patients with surgical versus endovascular aneurysm occlusion

Key secondary endpoints for part 2 of the study are:

• The test/retest reliability of the MoCA in patients with acute brain damage
• The influence of the intensive care environment on the MoCA in patients with acute brain damage

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

128 participants in 2 patient groups

DCI group

Description:

Patients that experience DCI, defined as 1. Cerebral infarction identified on imaging or proven at autopsy, after exclusion of procedure-related infarctions; and 2. Clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration will be assigned to the DCI group.

Treatment:

Other: There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.

non-DCI group

Description:

Patients not experiencing DCI as defined above.

Treatment:

Other: There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.