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Subarachnoid HemorrhageNCT03032471

Swiss SOS MoCA - DCI Study

An observational study of Subarachnoid Hemorrhage and Delayed Cerebral Ischemia, run by Swiss SOS Study Group at 6 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
128 participants
Where
6 sitesSwitzerland
Study dates
20 Jul 2017to 6 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: For part 1 of the study, patients with aneurysmal subarachnoid hemorrhage are recruited. For part 2 of the study, patients with acute brain injury are recruited.

Who may be able to join

  • 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)
Show all 16Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

Switzerland6 sites

  • Universitätsklinik für Neurochirurgie, Inselspital Bern

    Bern, 3010

  • Département des Neurosciences cliniques, Service de Neurochirurgie, Hôpitaux Universitaires de Genève

    Geneva, 1211

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Canton of Vaud, 1011

  • Primario Neurochirurgia, EOC Ospedale Regionale di Lugano - Civico e Italiano

    Lugano, Canton Ticino, 6900

  • Klinik für Neurochirurgie, Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Klinik für Neurochirurgie, Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Impact of Delayed Cerebral Ischemia (DCI) on the Neuropsychological Outcome After Aneurysmal Subarachnoid Hemorrhage - a SWISS SOS Multicentre Observational Study

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.

Read the detailed 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
Being tested
There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.
Keywords
Subarachnoid Hemorrhage, Delayed cerebral ischemia, Cognitive Impairment, Montreal Cognitive Assessment, MoCA, Cognitive Deterioration
Medical subject headings
Subarachnoid Hemorrhage, Stroke, Cognitive Dysfunction, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT03032471
Study groupRoleWhat they receive
DCI groupPatients 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.
Receives: Other: There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.
non-DCI groupPatients not experiencing DCI as defined above.
Receives: Other: There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuropsychological deterioration on the MoCA

    The primary endpoint is the in-subject difference of the MoCA before (48-72h after aSAH) and after the active phase of DCI (3 months after aSAH) between patients with and without DCI. The MoCA scores will be assessed by a neuropsychologist, not involved in the treatment of the patient and unaware of the patient's study group assignment (DCI vs. non-DCI).

    Measured: 3 months after Subarachnoid Hemorrhage

Secondary outcomes (12)

  1. Neuropsychological deterioration on the MoCA

    As for the primary outcome, the MoCA at 14-28 days after aSAH will be assessed by a neuropsychologist, not involved in the treatment of the patient and unaware of the patient's study group assignment (DCI vs. non-DCI)

    Measured: Up to 28 days after Subarachnoid Hemorrhage (directly after the DCI phase)

  2. Neuropsychological outcome

    Absolute results of the MoCA at 48-72h, 14-28 days and 3 months in patients that develop and those that do not develop DCI

    Measured: Up to 3 months after Subarachnoid Hemorrhage

  3. Reliability of the MoCA in patients with acute brain injury

    Reliability of the MoCA when tested in a (busy) intermediate care (IMC)/intensive care unit (ICU), as compared to the testing in a (quiet) setting in patients with acute brain injury.

    Measured: Up to 1 month following acute brain injury

  4. Test-retest reliability of the MoCA in patients with acute brain injury

    Test-retest reliability of the MoCA in patients with acute brain injury, tested two consecutive times with the MoCA (within 36 hours).

    Measured: Up to 1 month following acute brain injury

  5. Correlation between MoCA and CT-imaging

    Correlation of the MoCA at 48-72h with the ASPECTS score for ischemic lesions on the CT-scan at 24-72h

    Measured: Up to 72 hours after Subarachnoid Hemorrhage

  6. Correlation between MoCA and CT-imaging

    Correlation of the MoCA at 14-28 days with the ASPECTS score for ischemic lesions on the CT-scan at 12-21 days

    Measured: Up to 28 days after Subarachnoid Hemorrhage (directly after the DCI phase)

  7. Correlation between MoCA and CT-imaging

    Correlation of the MoCA at 3 months with the ASPECTS score for ischemic lesions on the CT-scan between 6 weeks and 3 months

    Measured: 3 months after Subarachnoid Hemorrhage

  8. Dependency/Mortality

    Will be assessed by a neuropsychologist, not involved in the treatment of the patient and unaware of the patient's study group assignment (DCI vs. non-DCI) based on the mRS at 3 months, where modified Rankin Scale (mRS) 4 and 5 is considered as dependency, and mRS 6 is considered dead

    Measured: 3 months after Subarachnoid Hemorrhage

  9. Health-related quality of life (HRQoL)

    Will be assessed by a neuropsychologist, not involved in the treatment of the patient and unaware of the patient's study group assignment (DCI vs. non-DCI) using the Euro-Qol (EQ-5D)

    Measured: 3 months after Subarachnoid Hemorrhage

  10. Shunt dependency (ventriculo-peritoneal or ventriculo-atrial shunt)

    Will be assessed by a neuropsychologist, not involved in the treatment of the patient and unaware of the patient's study group assignment (DCI vs. non-DCI)

    Measured: 3 months after Subarachnoid Hemorrhage

  11. Home time

    Length of time (in days) spent in own home or relative's home since Subarachnoid Hemorrhage. Will be assessed by a neuropsychologist, not involved in the treatment of the patient and unaware of the patient's study group assignment (DCI vs. non-DCI)

    Measured: 3 months after Subarachnoid Hemorrhage

  12. Minimum Clinically Important Difference (MCID) of the MoCA

    The MCID in patients with aneurysmal Subarachnoid Hemorrhage is determined using three different anchor-based approaches (using the GCS and NIHSS as anchors), namely the average change approach, minimum detectable change approach, and the change difference approach.

    Measured: Up to 3 months after Subarachnoid Hemorrhage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study start20 Jul 2017
  3. Primary completion6 May 2022
  4. Study completion6 May 2022

Why it stopped: COVID-restrictions on clinical research in Switzerland

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03032471
Sponsor's protocol ID
2017_MST_01
Status last verified
May 2022
First submitted
20 Jan 2017
Last updated
12 May 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Kalin V, Stienen MN, Zindel-Geisseler O, Dannecker N, Rothacher Y, Schlosser L, Velz J, Sebok M, Eggenberger N, May A, Bijlenga P, Guerra-Lopez U, Maduri R, Starnoni D, Beaud V, Chiappini A, Robert T, Bonasia S, Rossi S, Goldberg J, Fung C, Bervini D, Gutbrod K, Maldaner N, Fruh S, Schwind M, Zeitlberger AM, Hostettler IC, Bozinov O, Brugger P, Germans MR, Regli L; MoCA-DCI study group. Multidimensional outcome after endovascular or microsurgical occlusion of ruptured intracranial aneurysms - Comparative analysis of a prospective Swiss multicenter study. Brain Spine. 2025 Apr 29;5:104262. doi: 10.1016/j.bas.2025.104262. eCollection 2025.

    PubMed 40458420

  • Kalin V, Maschke S, Germans MR, Bijlenga P, Maduri R, Daniel RT, Robert T, Goldberg J, Bervini D, Zeitlberger AM, Bozinov O, Keller E, Regli L, Stienen MN, Hostettler IC. Impact of acute hydrocephalus after aneurysmal SAH on longitudinal cognitive outcome- post-hoc analysis of the MoCA-DCI study. Neurosurg Rev. 2025 Jun 3;48(1):476. doi: 10.1007/s10143-025-03635-6.

    PubMed 40457131

  • Stienen MN, Germans MR, Zindel-Geisseler O, Dannecker N, Rothacher Y, Schlosser L, Velz J, Sebok M, Eggenberger N, May A, Haemmerli J, Bijlenga P, Schaller K, Guerra-Lopez U, Maduri R, Beaud V, Al-Taha K, Daniel RT, Chiappini A, Rossi S, Robert T, Bonasia S, Goldberg J, Fung C, Bervini D, Maradan-Gachet ME, Gutbrod K, Maldaner N, Neidert MC, Fruh S, Schwind M, Bozinov O, Brugger P, Keller E, Marr A, Roux S, Regli L; MoCA-DCI Study Group; MoCA-DCI Study Group Contributors. Longitudinal neuropsychological assessment after aneurysmal subarachnoid hemorrhage and its relationship with delayed cerebral ischemia: a prospective Swiss multicenter study. J Neurosurg. 2022 Apr 29;137(6):1742-1750. doi: 10.3171/2022.2.JNS212595. Print 2022 Dec 1.

    PubMed 35535839

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage and Delayed Cerebral Ischemia, run by Swiss SOS Study Group at 6 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: COVID-restrictions on clinical research in Switzerland). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuropsychological deterioration on the MoCA (time frame: 3 months after Subarachnoid Hemorrhage). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03032471, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.

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