Subarachnoid Aneurysm HemorrhageSCOPE-aSAHNCT07723131
Structural and Clinical Predictors of Cognitive Impairment After Surgical Treatment for Ruptured Cerebral Aneurysms
An observational study of Subarachnoid Aneurysm Hemorrhage and Microsurgery, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
This study investigates the clinical and structural predictors of long-term cognitive impairment in patients who underwent microsurgical clipping for aneurysmal subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Aneurysm Hemorrhage, Microsurgery, Cognitive Impairment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2026to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Clinics Hospital - UNICAMP
Campinas, São Paulo, 13083888
Thiago M de Souza, MD, 005541999764051, souza.tmagalhaes@gmail.com
About this study
Official title: 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.
Read the 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.
- Keywords
- Aneurysmal Subarachnoid Hemorrhage, Aneurysm Clipping, Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 3 years
Secondary outcomes (5)
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.
Measured: Through study completion, an average of 3 years
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.
Measured: Through study completion, an average of 3 years
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).
Measured: Through study completion, an average of 3 years
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.
Measured: Through study completion, an average of 3 years
In-hospital complications
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.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Aneurysm HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas da Unicamp - SP
- Responsible party
- Principal investigator, Thiago Magalhaes de Souza, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723131
- Sponsor's protocol ID
- 8.525.150
- Acronym
- SCOPE-aSAH
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Clinical Predictors of Late Cognitive Impairment After Microsurgical Clipping of Ruptured Cerebral Aneurysms: A Retrospective Cohort With Prospective Assessment
- ClinicalTrials.gov ID
- NCT07723131
- Acronym / sponsor ID
- SCOPE-aSAH / 8.525.150
- Keywords
- Aneurysmal Subarachnoid Hemorrhage, Aneurysm Clipping, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Hospital de Clinicas da Unicamp - SP
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Aneurysm Hemorrhage and Microsurgery, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) score (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.