NCT03032471

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

July 20, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

4.8 years

First QC Date

January 20, 2017

Last Update Submit

May 6, 2022

Conditions

Subarachnoid HemorrhageDelayed Cerebral IschemiaStrokeComplicationCognitive ImpairmentCognitive DeficitCognitive DeteriorationCognitive Deficits Following Cerebral Infarction

Keywords

Subarachnoid HemorrhageDelayed cerebral ischemiaCognitive ImpairmentMontreal Cognitive AssessmentMoCACognitive Deterioration

Outcome Measures

Primary Outcomes (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).

    3 months after Subarachnoid Hemorrhage

Secondary Outcomes (12)

  • Neuropsychological deterioration on the MoCA

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

  • Neuropsychological outcome

    Up to 3 months after Subarachnoid Hemorrhage

  • Reliability of the MoCA in patients with acute brain injury

    Up to 1 month following acute brain injury

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

    Up to 1 month following acute brain injury

  • Correlation between MoCA and CT-imaging

    Up to 72 hours after Subarachnoid Hemorrhage

  • +7 more secondary outcomes

Other Outcomes (3)

  • Random number generation

    Up to 1 month following acute brain injury

  • Outcomes in patients with hydrocephalus vs. without hydrocephalus

    Up to 3 months after Subarachnoid Hemorrhage

  • Outcomes in patiens treated surgically vs. endovascularly (aneurysm occlusion)

    Up to 3 months after Subarachnoid Hemorrhage

Study Arms (2)

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.

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.

Interventions

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.

DCI groupnon-DCI group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • For part 1 of 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:
  • 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

You may not qualify if:

  • For part 1 of the study:
  • 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:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

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

Lugano, Canton Ticino, 6900, Switzerland

Location

Universitätsklinik für Neurochirurgie, Inselspital Bern

Bern, 3010, Switzerland

Location

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

Geneva, 1211, Switzerland

Location

Klinik für Neurochirurgie, Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Klinik für Neurochirurgie, Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 40458420DERIVED

  • 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.

    PMID: 40457131DERIVED

  • 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.

    PMID: 35535839DERIVED

MeSH Terms

Conditions

Subarachnoid HemorrhageStrokeCognitive DysfunctionCognition Disorders

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 26, 2017

Study Start

July 20, 2017

Primary Completion

May 6, 2022

Study Completion

May 6, 2022

Last Updated

May 12, 2022

Record last verified: 2022-05

Locations

CH(6)