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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Campinas, Brazil

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Non-aneurysmal subarachnoid hemorrhage.

Exclusively endovascular treatment.

Previous diagnosis of dementia.

Severe neurological or psychiatric disorders unrelated to aSAH with significant cognitive impact.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 3 trial groups
Group A: Operated <24h
Group B: Operated 24-72h
Group C: Operated >72h

Trial outcomes

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.

Time frame
Through study completion, an average of 3 years

Secondary outcomes

1

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

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.

Time frame
Through study completion, an average of 3 years
2

Hospital Anxiety and Depression Scale (HADS)

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.

Time frame
Through study completion, an average of 3 years
3

Modified Rankin Scale (mRS)

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).

Time frame
Through study completion, an average of 3 years
4

Return to work

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.

Time frame
Through study completion, an average of 3 years

Other outcomes

Sponsors and contacts

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University of Campinas, Brazil

Lead sponsor

Hospital de Clinicas da Unicamp - SP

Collaborator

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