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Not yet recruiting NCT07723131

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

Observational Subarachnoid Aneurysm Hemorrhage Microsurgery Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Subarachnoid Aneurysm Hemorrhage, Microsurgery, Cognitive Impairment. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Montreal Cognitive Assessment (MoCA) score [Time frame: Through study completion, an average of 3 years]
Secondary outcome measures (5)
  • EuroQol 5-Dimension 5-Level (EQ-5D-5L) [Time frame: Through study completion, an average of 3 years]
  • Hospital Anxiety and Depression Scale (HADS) [Time frame: Through study completion, an average of 3 years]
  • Modified Rankin Scale (mRS) [Time frame: Through study completion, an average of 3 years]
  • Return to work [Time frame: Through study completion, an average of 3 years]
  • In-hospital complications [Time frame: Through study completion, an average of 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Brazil · 1 center
  • Clinics Hospital - UNICAMP — Campinas

Identifiers

NCT: NCT07723131 · 8.525.150

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗