An interventional study of Clipping and Endovascular embolization in Anxiety Depression, Aneurysm Cerebral and Mental Health Wellness 1, sponsored by Montefiore Medical Center. Suspended at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Prevention
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.
This is a controlled, non-randomized, prospective cohort study with parallel arms of treatment arm with microsurgical and endovascular treatment and comparison control arm with conservative management/observation of UIA. The goal of this study is to investigate the impact of the awareness of an untreated UIA on the psychiatric and mental status of the patients enrolled in the control arm compared to patients with a treated UIA. All patients presenting to the outpatient clinic upon the initiation of the trial and for 2 years ahead with UIA diagnosed on any of the angiographic imaging modalities including Computed Tomography Angiography (CTA), Magnetic Resonance Angiography (MRA), and Digital Subtraction Angiogram (DSA) will be included.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's planned enrollment of 120 is close to the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Montefiore Medical Center is the lead sponsor of 403 studies on the registry; 71 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
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Observation Group: All patients with UIAs that are eligible for conservative management
Exclusion Criteria:
Patients with unruptured intracranial aneurysms, opting for active intervention undergo microsurgical clipping or endovascular therapy to preemptively secure the aneurysm and prevent rupture.
Procedure: Clipping · Procedure: Endovascular embolization
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.
Diagnostic Test: Surveillance imaging
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.
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 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.
Anxiety
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.
Time frame: 6 months
Anxiety
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.
Time frame: 18 months
Depression
The number of participants demonstrating depression 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 depression 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 depression. The number of participants with HADS scores of 8 and above will be considered to demonstrate positive signs of depression.
Time frame: 6 months and 18 months
Aneurysm rupture
The number of participants with any recorded event of aneurysm rupture during the follow-up periods of observed or treated Unruptured Intracranial Aneurysm (UIA) will be determined.
Time frame: 6 months and 18 months
Significant Aneurysm Growth
The number of participants demonstrating significant aneurysm growth during the follow-up periods will be determined. Significant aneurysm growth is defined as any aneurysm growth of \>= 3 millimeters of observed or treated UIA.
Time frame: 6 months and 18 months
Change in Neurologic Status
The number of participants with change in neurologic status will be determined using the National Institute of Health (NIH) Stroke Scale/Score (NIHSS). The NIHSS is a 15-item neurological examination with each item scored on a 3- to 5-point scale, with 0 as normal. Scores range from 0-42 and there is an allowance for untestable items. Progressive increase in NIHSS score by 2 or more points after the procedure and through study completion will be considered as a bad outcome.
Time frame: 6 months and 18 months
Functional Outcome Status
The number of participants demonstrating favorable functional outcome status will be assessed using a modified Rankin Scale (mRS) score. Participants with scores ranging from 0 (no disability) to 2 (slight disability) will be considered to have a favorable functional outcome status. Participants with mRS scores ranging from 3 (Moderate disability) to 5 (severe disability) will be considered to have an unfavorable functional outcome status.
Time frame: 6 months and 18 months
Acute adverse events
The number of acute adverse events during hospital admission will be tabulated. Acute adverse events will encompass management and procedure-related complications. Increased incidence of procedure-related complications portends more unfavorable outcomes.
Time frame: During admission
Delayed adverse events
The number of delayed adverse events will be tabulated. Delayed adverse events will encompass management and procedure-related complications. Increased incidence of procedure-related complications portends more unfavorable outcomes.
Time frame: 3 months
Plan to share: Undecided
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