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Swiss SOS MoCA - DCI Study

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ClinicalTrials.gov Identifier: NCT03032471
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
Universitätsklinik für Neurochirurgie, Inselspital Bern
Département des Neurosciences cliniques, Service de Neurochirurgie, Hôpitaux Universitaires de Genève
Primario Neurochirurgia, EOC Ospedale Regionale di Lugano - Civico e Italiano
Klinik für Neurochirurgie, Kantonsspital St. Gallen
Klinik für Neurochirurgie, Universitätsspital Zürich
Abteilung für Neuropsychologie, Universitätsklinik für Neurologie, Inselspital Bern
Primario Neurologia, EOC Ospedale Regionale di Lugano - Civico e Italiano
Abteilung für Neuropsychologie, Klinik für Neurologie, Kantonsspital St.Gallen
Abteilung für Neuropsychologie, Klinik für Neurologie, Universitätsspital Zürich
Département des Neurosciences cliniques, Service de Neurochirurgie, CHUV, Lausanne
Département des Neurosciences cliniques, Service de Neurologie, CHUV, Lausanne
Département des Neurosciences cliniques, Service de Neurologie, Hôpitaux Universitaires de Genève
Information provided by (Responsible Party):
Swiss SOS Study Group

Brief 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.

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.


Condition or disease Intervention/treatment
Subarachnoid Hemorrhage Delayed Cerebral Ischemia Stroke Complication Cognitive Impairment Cognitive Deficit Cognitive Deterioration Cognitive Deficits Following Cerebral Infarction Other: There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Delayed Cerebral Ischemia (DCI) on the Neuropsychological Outcome After Aneurysmal Subarachnoid Hemorrhage - a SWISS SOS Multicentre Observational Study
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020

Group/Cohort Intervention/treatment
DCI group

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

non-DCI group
Patients not experiencing DCI as defined above.
Other: There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.
There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.




Primary Outcome Measures :
  1. Neuropsychological deterioration on the MoCA [ Time Frame: 3 months after Subarachnoid Hemorrhage ]
    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).


Secondary Outcome Measures :
  1. Neuropsychological deterioration on the MoCA [ Time Frame: Up to 28 days after Subarachnoid Hemorrhage (directly after the DCI phase) ]
    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)

  2. Neuropsychological outcome [ Time Frame: Up to 3 months after Subarachnoid Hemorrhage ]
    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

  3. Reliability of the MoCA in patients with acute brain injury [ Time Frame: Up to 1 month following 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.

  4. Test-retest reliability of the MoCA in patients with acute brain injury [ Time Frame: Up to 1 month following 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).

  5. Correlation between MoCA and CT-imaging [ Time Frame: Up to 72 hours after Subarachnoid Hemorrhage ]
    Correlation of the MoCA at 48-72h with the ASPECTS score for ischemic lesions on the CT-scan at 24-72h

  6. Correlation between MoCA and CT-imaging [ Time Frame: Up to 28 days after Subarachnoid Hemorrhage (directly after the DCI phase) ]
    Correlation of the MoCA at 14-28 days with the ASPECTS score for ischemic lesions on the CT-scan at 12-21 days

  7. Correlation between MoCA and CT-imaging [ Time Frame: 3 months after Subarachnoid Hemorrhage ]
    Correlation of the MoCA at 3 months with the ASPECTS score for ischemic lesions on the CT-scan between 6 weeks and 3 months

  8. Dependency/Mortality [ Time Frame: 3 months after 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) 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

  9. Health-related quality of life (HRQoL) [ Time Frame: 3 months after 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) using the Euro-Qol (EQ-5D)

  10. Shunt dependency (ventriculo-peritoneal or ventriculo-atrial shunt) [ Time Frame: 3 months after 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)

  11. Home time [ Time Frame: 3 months after Subarachnoid Hemorrhage ]
    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)

  12. Minimum Clinically Important Difference (MCID) of the MoCA [ Time Frame: Up to 3 months after Subarachnoid Hemorrhage ]
    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.


Other Outcome Measures:
  1. Random number generation [ Time Frame: Up to 1 month following acute brain injury ]
    Random number generation, as a test of frontal executive functions in patients with acute brain injury will be assessed using the mental dice task by a neuropsychologist not involved in the treatment of the patient.

  2. Outcomes in patients with hydrocephalus vs. without hydrocephalus [ Time Frame: Up to 3 months after Subarachnoid Hemorrhage ]
    Outcomes 1, 2, 3 and 9-12 will be compared between patients that develop or do not develop hydrocephalus up to 3 months after Subarachnoid Hemorrhage.

  3. Outcomes in patiens treated surgically vs. endovascularly (aneurysm occlusion) [ Time Frame: Up to 3 months after Subarachnoid Hemorrhage ]
    Outcomes 1, 2, 3 and 9-12 will be compared between patients that are treated surgically or endovascularly up to 3 months after Subarachnoid Hemorrhage.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032471


Contacts
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Contact: Martin N. Stienen, PD Dr. med. +41-44-255-1111 mnstienen@gmail.com
Contact: Luca Regli, Prof. Dr. med. +41-44-255-1111 luca.regli@usz.ch

Locations
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Switzerland
Primario Neurochirurgia, EOC Ospedale Regionale di Lugano - Civico e Italiano Recruiting
Lugano, Ticino, Switzerland, 6900
Contact: Thomas Robert, Dr. med.    091 811 64 60    thomas.robert@eoc.ch   
Centre Hospitalier Universitaire Vaudois (CHUV) Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Rodolfo Maduri, MD    021 314 1111    Rodolfo.Maduri@chuv.ch   
Universitätsklinik für Neurochirurgie, Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Christian Fung, PD Dr. med.    031 632 24 09    christian.fung@insel.ch   
Département des Neurosciences cliniques, Service de Neurochirurgie, Hôpitaux Universitaires de Genève Recruiting
Genève, Switzerland, 1211
Contact: Philippe Bijlenga, PD Dr. med.    022 372 52 87    philippe.bijlenga@hcuge.ch   
Klinik für Neurochirurgie, Kantonsspital St. Gallen Recruiting
St.Gallen, Switzerland, 9007
Contact: Martin A Seule, Dr. med.    071 494 18 86    martin.seule@kssg.ch   
Klinik für Neurochirurgie, Universitätsspital Zürich Recruiting
Zürich, Switzerland, 8091
Contact: Martin N Stienen, PD Dr. med.    044 255 93 21    mnstienen@gmail.com   
Sub-Investigator: Oliver Bozinov, PD Dr. med.         
Sub-Investigator: Menno R Germans, MD/PhD         
Sponsors and Collaborators
Swiss SOS Study Group
Universitätsklinik für Neurochirurgie, Inselspital Bern
Département des Neurosciences cliniques, Service de Neurochirurgie, Hôpitaux Universitaires de Genève
Primario Neurochirurgia, EOC Ospedale Regionale di Lugano - Civico e Italiano
Klinik für Neurochirurgie, Kantonsspital St. Gallen
Klinik für Neurochirurgie, Universitätsspital Zürich
Abteilung für Neuropsychologie, Universitätsklinik für Neurologie, Inselspital Bern
Primario Neurologia, EOC Ospedale Regionale di Lugano - Civico e Italiano
Abteilung für Neuropsychologie, Klinik für Neurologie, Kantonsspital St.Gallen
Abteilung für Neuropsychologie, Klinik für Neurologie, Universitätsspital Zürich
Département des Neurosciences cliniques, Service de Neurochirurgie, CHUV, Lausanne
Département des Neurosciences cliniques, Service de Neurologie, CHUV, Lausanne
Département des Neurosciences cliniques, Service de Neurologie, Hôpitaux Universitaires de Genève

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Responsible Party: Swiss SOS Study Group
ClinicalTrials.gov Identifier: NCT03032471     History of Changes
Other Study ID Numbers: 2017_MST_01
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Keywords provided by Swiss SOS Study Group:
Subarachnoid Hemorrhage
Delayed cerebral ischemia
Cognitive Impairment
Montreal Cognitive Assessment
MoCA
Cognitive Deterioration
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Cerebral Infarction
Brain Ischemia
Infarction
Hemorrhage
Ischemia
Cognitive Dysfunction
Cognition Disorders
Pathologic Processes
Necrosis
Neurocognitive Disorders
Mental Disorders
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke