Recruiting

Observational Study

Sponsor:

Montefiore Medical Center

Code:

NCT06123325

Conditions

Anxiety Depression

Aneurysm Cerebral

Mental Health Wellness 1

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Clipping

Endovascular embolization

Surveillance imaging

Study Details

Brief 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.

Conditions

Anxiety Depression

Aneurysm Cerebral

Mental Health Wellness 1

Study ID

NCT06123325

Start date

Dec 1, 2023

Status verified date

Nov, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Unruptured intracranial aneurysms (UIA)
  • mRS scores between 0-1
  • Observation Group: All patients with UIAs that are eligible for conservative management

1. Specific locations that are not good candidates for interventional treatment, such as cavernous internal carotid artery and very distally located aneurysms
2. Aneurysm size (largest dimension) is less than 4 mm
  • 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 Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment group

Patients with unruptured intracranial aneurysms, opting for active intervention undergo microsurgical clipping or endovascular therapy to preemptively secure the aneurysm and prevent rupture.

other: Observation group

Patients with unruptured intracranial aneurysms, opting for conservative management undergo regular monitoring with serial imaging to track aneurysm stability, deferring interventional treatment unless changes indicate an increased risk of rupture.

Interventions

Clipping

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.

Endovascular 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.

Surveillance 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.

Primary outcome measure

  • Anxiety [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Muhammed Amir Essibayi, MD

718-920-7498muhammedamir.essibayi@einsteinmed.edu

Genesis Liriano, MD

718-920-2469gliriano@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

David J Altschul, MD

718-920-7498daltschu@montefiore.org

Principal Investigator:

David J Altschul, MD

More Information

Sponsor

Montefiore Medical Center

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

  • Cerebral aneurysm
  • Anxiety
  • Depression
  • Endovascular
  • Clipping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2025-11-19.