Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA) Study

This study, called POUIA, is looking at the mental health impact of unruptured brain aneurysms. Researchers want to understand how knowing you have an aneurysm, and whether it's treated, affects anxiety and depression. They will compare people who have their aneurysm treated with either "clipping" (surgery to place a small metal clip) or "endovascular embolization" (a procedure using coils or other materials to block the aneurysm) to those who are simply monitored with "surveillance imaging" (regular scans like MRI or CTA). The study aims to see if there's a difference in anxiety levels after 6 months. You might be able to join if you are between 18 and 75 years old, have an unruptured brain aneurysm, and have good functional ability (mRS scores 0-1). The current recruitment status is unclear.

Study design: This is a controlled, non-randomized study comparing two groups: one receiving treatment (clipping or endovascular embolization) and another receiving observation. It aims to enroll 120 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants' anxiety levels will be measured at 6 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

Recruiting

NAAges 18–75InterventionalPrevention

Montefiore Medical Center

~120 participants

Updated 2025-11-19 on ClinicalTrials.gov

What's tested:ClippingEndovascular embolizationSurveillance imaging

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Anxiety

Measured over 6 months

Conditions

Anxiety Depression

Aneurysm Cerebral

Mental Health Wellness 1

NCT06123325

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Montefiore Medical Center
The Bronx, New Yorkstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

David J Altschul, MD · PRINCIPAL_INVESTIGATOR · Associate Professor at The Leo M. Davidoff Department of Neurological Surgery at Montefiore

Who to contact

Muhammed Amir Essibayi, MD

[email protected]

718-920-7498

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Unruptured intracranial aneurysms (UIA)

mRS scores between 0-1

Observation Group: All patients with UIAs that are eligible for conservative management

Treatment Group: All patients with UIAs that are decided to be treated either with endovascular or microsurgical treatments due to several reasons, such as aneurysm size above 4 mm, patient's decision

Exclusion

Prior history of Subarachnoid Hemorrhage (SAH)

Prior history of intracranial aneurysm

Severe comorbidities that impact the mental health of the patients, such severe psychiatric disease, and chronic end stage diseases

Traumatic, mycotic, dissecting, or fusiform aneurysms

Patients with communication barriers (does not include foreign language), developmental disability, or psychiatric illness that prevent understanding of the questions required to complete assessments

Patients with any physical disabilities or handicaps

What this trial measures

Anxiety6 months
The number of participants demonstrating anxiety will be determined using the Hospital Anxiety and Depression Scale (HADS) assessment tool. HADS is a widely used tool to evaluate anxiety and depression levels and is composed of 14 items in total, 7 items for anxiety and 7 for depression. The 7 anxiety subscale items are to be answered subjectively by patients using a four-point Likert scale (0-3) with a possible scoring range of 0-21 for anxiety. The number of participants with HADS scores of 8 and above will be considered to demonstrate positive signs of anxiety.

Trialytics