Structural and Clinical Predictors of Cognitive Impairment After Surgical Treatment for Ruptured Cerebral Aneurysms (SCOPE-aSAH)

July 20, 2026 updated by: Thiago Magalhaes de Souza, University of Campinas, Brazil

Structural and Clinical Predictors of Late Cognitive Impairment After Microsurgical Clipping of Ruptured Cerebral Aneurysms: A Retrospective Cohort With Prospective Assessment

This study investigates the clinical and structural predictors of long-term cognitive impairment in patients who underwent microsurgical clipping for aneurysmal subarachnoid hemorrhage. Using a retrospective cohort with prospective neuropsychological and MRI assessments, it aims to identify factors associated with late cognitive deficits and improve prognostic stratification, rehabilitation planning, and long-term patient care.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Aneurysmal subarachnoid hemorrhage (aSAH) is associated with substantial morbidity, even among patients who remain functionally independent after treatment. Late cognitive deficits, particularly involving memory, attention, and executive function, are common in patients undergoing microsurgical clipping of ruptured cerebral aneurysms; however, the underlying mechanisms remain poorly understood. This study aims to identify clinical, acute radiological, and late structural predictors associated with cognitive impairment in these patients.

Participants will undergo a standardized late postoperative brain magnetic resonance imaging (MRI) evaluation (>1 year after treatment). Structural imaging variables to be analyzed as potential predictors of cognitive impairment include the presence or absence of hippocampal atrophy, frontal lobe atrophy, posterior cerebellar atrophy, pituitary gland atrophy, and deep gray nuclei atrophy, as well as quantitative measurements of white matter hyperintensity volume on FLAIR MRI, residual infarct volume, and cerebral perfusion. These imaging variables will be evaluated in combination with clinical and acute radiological characteristics to identify independent predictors of late cognitive impairment.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients who underwent microsurgical clipping of ruptured cerebral aneurysms following aneurysmal subarachnoid hemorrhage (aSAH), with symptom onset occurring in or after 2020, and who are currently under outpatient follow-up at HC-UNICAMP, will be eligible for inclusion.

Description

Inclusion Criteria:

  • Age ≥18 years at the time of aSAH.
  • Treatment by microsurgical clipping of a ruptured cerebral aneurysm.
  • Survival until study recruitment.
  • Ability to understand and sign informed consent.

Exclusion Criteria:

  • Non-aneurysmal subarachnoid hemorrhage.
  • Exclusively endovascular treatment.
  • Previous diagnosis of dementia.
  • Severe neurological or psychiatric disorders unrelated to aSAH with significant cognitive impact.
  • Absolute contraindication to MRI.
  • Severe aphasia preventing adequate neuropsychological evaluation.
  • Incomplete clinical data.
  • Inability to attend in-person assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Operated <24h
Patients submited to microsurgical clipping <24h after aneurysmal subarachnoid hemorrhage
Operated 24-72h
Patients submited to microsurgical clipping between 24h and 72h after aneurysmal subarachnoid hemorrhage
Operated >72h
Patients submited to microsurgical clipping >72h after aneurysmal subarachnoid hemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA) score
Time Frame: Through study completion, an average of 3 years
The MoCA is a global cognitive screening test with scores ranging from 0 to 30, where higher scores indicate better cognitive function. Cognitive impairment is defined as a MoCA score <25, adjusted for educational level. A secondary analysis will also classify participants with MoCA <23, adjusted for educational level, representing unfavorable functional outcome.
Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time Frame: Through study completion, an average of 3 years
The EQ-5D-5L descriptive system generates a health utility index score ranging from less than 0 (health states considered worse than death) to 1.0 (full health), depending on the country-specific value set. Higher scores indicate better health-related quality of life.
Through study completion, an average of 3 years
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Through study completion, an average of 3 years
proportion of patients with anxiety or depression. The HADS consists of two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each ranging from 0 to 21, with higher scores indicating greater symptom severity. The outcome is defined as the proportion of participants with a score ≥8 on either the HADS-A (anxiety) or HADS-D (depression) subscale, consistent with clinically significant symptoms.
Through study completion, an average of 3 years
Modified Rankin Scale (mRS)
Time Frame: Through study completion, an average of 3 years
proportion of patients with favorable functional outcome. The Modified Rankin Scale ranges from 0 to 6, where 0 indicates no symptoms, 5 indicates severe disability requiring constant care, and 6 indicates death. Higher scores indicate worse functional outcome. The outcome is defined as the proportion of participants with a favorable functional outcome (mRS 0-2) versus an unfavorable functional outcome (mRS 3-6).
Through study completion, an average of 3 years
Return to work
Time Frame: Through study completion, an average of 3 years
proportion of patients returning to work. This outcome is defined as the proportion of participants who returned to paid employment after aneurysmal subarachnoid hemorrhage and microsurgical clipping (yes/no). Among participants who returned to work, the proportion requiring workplace adaptations or modifications (yes/no) will also be assessed.
Through study completion, an average of 3 years
In-hospital complications
Time Frame: Through study completion, an average of 3 years
Proportion of participants experiencing in-hospital complications. Each complication will be recorded as a binary outcome (yes/no) during the index hospitalization for aneurysmal subarachnoid hemorrhage. Complications include aneurysm rebleeding, hydrocephalus, need for surgical revision, infection, and delayed cerebral ischemia.
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Hospital de Clinicas da Unicamp - SP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

July 16, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8.525.150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes. De-identified individual participant data will be made available upon reasonable request to the corresponding author, following publication of the primary results, subject to approval of a data access agreement and institutional/ethical requirements.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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