RecruitingNot ApplicableNCT06123325

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

Impact of Observation Versus Treatment on The Psychiatric and Mental Outcomes of Patients With Unruptured Intracranial Aneurysms

Sponsor

Montefiore Medical Center

Enrollment

120 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Anxiety Depression Aneurysm Cerebral Mental Health Wellness 1

Summary

The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. Unruptured Intracranial aneurysms (UIAs) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. Despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. Nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of UIA diagnosis has been found to result in worse outcomes of health-related quality of life. This study aims to investigate the impact of awareness of untreated UIA on the patients' mental health utilizing the Hospital Anxiety and Depression Scale (HADS) tool.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tracks the mental health and quality of life of people who have been found to have an unruptured brain aneurysm (a bulge in a blood vessel in the brain that has not yet burst). Researchers want to understand how the diagnosis and treatment decision — whether to treat or just monitor the aneurysm — affects anxiety, depression, and wellbeing. **You may be eligible if...** - You have been diagnosed with an unruptured brain aneurysm - Your level of disability is minimal (mRS score of 0 or 1) - You are either being monitored without treatment OR having treatment (endovascular or surgical) **You may NOT be eligible if...** - You have a history of a previous brain bleed (subarachnoid hemorrhage) or prior aneurysm - You have severe psychiatric illness or a terminal medical condition - Your aneurysm is of a special type (traumatic, infectious, dissecting, or fusiform) - You have communication difficulties (other than language barriers), developmental disability, or a physical handicap Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREClipping

Microsurgical clipping of intracranial aneurysms involves craniotomy to access the brain, locating the aneurysm, and placing a small metal clip across its neck, thereby isolating it from normal blood circulation to prevent rupture.

PROCEDUREEndovascular embolization

Any endovascular embolization of intracranial aneurysms that involves navigating microcatheters through the vascular system to the site of the aneurysm and deploying materials like coils, flow-diverting stents, or endosaccular flow disruptors to occlude the aneurysm and reduce the risk of rupture.

DIAGNOSTIC_TESTSurveillance imaging

Surveillance imaging for brain aneurysms is a diagnostic approach that uses imaging techniques such as MRI, MRA, CTA, or DSA to regularly monitor the status of detected brain aneurysms. The goal is to track changes in the aneurysm's size, shape, or structure over time, which may indicate an increased risk of rupture. This ongoing assessment helps healthcare providers decide whether to continue monitoring or to consider treatment options, such as surgical clipping or endovascular coiling, based on the aneurysm's characteristics and the patient's risk factors.