Impact of unruptured brain aneurysms on mental health
Impact of Observation Versus Treatment on The Psychiatric and Mental Outcomes of Patients With Unruptured Intracranial Aneurysms
NA · Montefiore Medical Center · NCT06123325
This study looks at how knowing you have an untreated brain aneurysm affects anxiety and depression in patients, comparing those who get treatment with those who don’t.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center (other) |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06123325 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how the awareness of untreated unruptured intracranial aneurysms (UIAs) affects the mental health of patients, particularly focusing on anxiety and depression. It involves a controlled, non-randomized, prospective cohort design with two arms: one receiving treatment for UIAs and the other undergoing conservative management. The study will utilize the Hospital Anxiety and Depression Scale (HADS) to assess the psychiatric outcomes of patients over a two-year period. Participants will be recruited from an outpatient clinic and will include those diagnosed with UIAs through various imaging modalities.
Who should consider this trial
Good fit: Ideal candidates are patients with unruptured intracranial aneurysms who have a modified Rankin Scale (mRS) score between 0-1.
Not a fit: Patients with a prior history of intracranial hemorrhage or severe psychiatric diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mental health outcomes for patients diagnosed with unruptured intracranial aneurysms.
How similar studies have performed: While the specific impact of UIAs on mental health is not well-studied, similar approaches in assessing the psychological effects of chronic health conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (RECRUITING)
Study contacts
- Principal investigator: David J Altschul, MD — Associate Professor at The Leo M. Davidoff Department of Neurological Surgery at Montefiore
- Study coordinator: Muhammed Amir Essibayi, MD
- Email: muhammedamir.essibayi@einsteinmed.edu
- Phone: 718-920-7498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anxiety Depression, Aneurysm Cerebral, Mental Health Wellness 1, Cerebral aneurysm, Anxiety, Depression, Endovascular, Clipping