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

NCT07723131 | Not Yet Recruiting

• 1 other identifier: 8.525.150
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subarachnoid Aneurysm Hemorrhage; Microsurgery; Cognitive Impairment

Keywords

Aneurysmal Subarachnoid Hemorrhage; Aneurysm Clipping; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MoCA) score

  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 Outcomes (5)

• EuroQol 5-Dimension 5-Level (EQ-5D-5L)

  Through study completion, an average of 3 years

• Hospital Anxiety and Depression Scale (HADS)

  Through study completion, an average of 3 years

• Modified Rankin Scale (mRS)

  Through study completion, an average of 3 years

• Return to work

  Through study completion, an average of 3 years

• In-hospital complications

  Through study completion, an average of 3 years

Study Arms (3)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Hospital de Clinicas da Unicamp - SP: collaborator

Study Sites (1)

Clinics Hospital - UNICAMP

Campinas, São Paulo, 13083888, Brazil

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

BR (1)