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NCT Number: NCT07723131

Structural and Clinical Predictors of Cognitive Impairment After Surgical Treatment for Ruptured Cerebral Aneurysms

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.

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Key information

Conditions

Subarachnoid Aneurysm Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Hemorrhage Intracranial Hemorrhages Mental Disorders Microsurgery Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Hospital de Clinicas da Unicamp - SP

Registry information

Official study title

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

Acronym: SCOPE-aSAH

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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