Neurosurgery: Clinical Studies Open For Enrollment
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Eligibility
- 18 years to 90 years of age
- Pre-morbid Modified Rankin Score less than or equal to 3
- Confirmed diagnosis of subacute or chronic subdural hematoma
- Completed informed consent
- Meets criteria for Surgery or Observation Cohort
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT04402632
Principal Investigator
Justin Santarelli, MD
Contact for Study Screening
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Eligibility
- 18 years to 90 years of age
- Pre-randomization mRS less than or equal to 3
- Confirmed diagnosis of chronic subdural hematoma
- Completed informed consent
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT04816591
Principal Investigator
Fawaz Al-Mufti, MD
Contact for Study Screening
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Eligibility
- Patient is between 21 and 80 years of age
- Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils
- Patient is able and willing to comply with protocol and follow-up requirements
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT03642639
Principal Investigator
Fawaz Al-Mufti, MD
Contact for Study Screening
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Eligibility
Patients eligible for this study have been diagnosed with a malignant brain tumor and, with their doctor, decided to use GammaTiles, a type of radiation treatment, to help treat their brain tumor after surgery.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT04427384
Principal Investigator
Simon Hanft, MD
Contact for Study Screening
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Eligibility
This study is being conducted for adult participants (≥18 – 70 years old) that have a brain tumor called a glioblastoma (GBM). The purpose of the study is to see whether a combination of the investigational drug (IGV-001) plus standard of care (SOC) or placebo plus SOC is more effective in slowing GBM tumor regrowth and to see if IGV-001 is safe.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT04485949
Principal Investigator
Simon Hanft, MD
Contact for Study Screening
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Eligibility
Patients eligible for this study are scheduled to undergo brain surgery (craniotomy) to treat suspected or diagnosed glioblastoma (GBM), a type of brain cancer. Participation in this study includes donation of tumor tissue and a blood sample, and some information from medical records.
Enrollment Status: Actively enrolling
Principal Investigator
Simon Hanft, MD
Contact for Study Screening
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Eligibility
The purpose of this research study is to show whether an investigational device, called the Contour Neurovascular System™, is safe and effective to control brain aneurysms in adult patients (18-75 years old). The Contour Neurovascular System™ is a brain implant intended to stop the growth of brain aneurysms and form a barrier between the aneurysm and the blood flow.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT04852783
Principal Investigator
Fawaz Al-Mufti, MD
Contact for Study Screening
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Eligibility
Patients eligible for this study are at least 18 years old and will have recently been diagnosed with a brain hemorrhage. Eligible patients will have also been diagnosed with an irregular heart rate which is a condition known as atrial fibrillation. This study is being done because survivors of intracerebral hemorrhage (ICH) who have atrial fibrillation (AF) are at high risk for subsequent ischemic stroke. An “ischemic” stroke is an injury to the brain caused by a blocked blood vessel supplying the brain. Atrial fibrillation is a common cause of ischemic stroke. In people with atrial fibrillation, blood clots can form in the heart. These clots can break free, travel to the brain, block a blood vessel, and cause a stroke. Blood thinners are the best way to decrease the risk of ischemic stroke in patients with atrial fibrillation. Apixaban (also known as Eliquis®) and aspirin are two types of blood thinner medications. The purpose of this research study is to compare the effects (good and bad) of apixaban with the effects (good and bad) of aspirin in patients with atrial fibrillation and a recent brain hemorrhage to see which is better at preventing future strokes and death. Apixaban is approved by the U.S. Food and Drug Administration (FDA) for stroke prevention in patients with atrial fibrillation. The FDA does not address the use of apixaban in patients with Atrial Fibrillation who have suffered an ICH because apixaban has not been studied in these patients.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT03907046
Principal Investigator
Stephan A. Mayer, MD
Contact for Study Screening
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Eligibility
- Male or female at least18 years of age
- Participants who have an acute onset of neurological deficit attributed to non-cardioembolic focal brain ischemia; Non-cardioembolic ischemic stroke with NIHSS ≤ 15 at randomization and/or High-risk TIA with complete resolution of symptoms within < 24 hours and an ABCD2 score ≥ 6 with negative neuroimaging (CT or MRI) for acute ischemia.
- Cerebrovascular atherosclerosis defined as vascular imaging (CTA, MRA, ultrasound, DSA) showing atherosclerotic plaque involving intracranial or extracranial cerebral arteries or the aortic arch.
- Plan for secondary prevention of stroke/TIA with single or dual antiplatelet therapy including ASA, clopidogrel, ticagrelor, prasugrel, cilostazol and dipyridamole and in line with local guidelines.
- Exclusion: for matched healthy controls; Recent ischemic stroke within seven days before index stroke event, Dysphagia with inability to safely swallow study medication at time of randomization and History of atrial fibrillation / flutter, left ventricular thrombus, mechanical valve or other cardioembolic source of stroke requiring anticoagulation.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05686070
Principal Investigator
Stephan A. Mayer, MD
Contact for Study Screening
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Eligibility
- Male or female at least 18 years of age
- One to four newly diagnosed brain metastases, identified on the screening MRI, from an extracranial primary tumor.
- One lesion, designated the index lesion, is planned for surgical resection and is to be between 2.5 cm and 5.0 cm on the screening MRI. Index lesions > 2.0 cm but <2.5 cm are also eligible if surgery is deemed clinically necessary and appropriate for an attempted gross total resection by the neurosurgeon.
- Non-index lesions must measure < 4.0 cm in maximal extent on the screening MRI brain scan. The unresected lesions will be treated with SRT as outlined in the treatment section of the concept.
- All metastases must be located > 5 mm from the optic chiasm and outside the brainstem. Dural based metastasis are eligible.
- KPS score of ≥70.
- Adequate renal and hepatic function to undergo surgery, in investigators opinion.
- Ability to complete an MRI of the head with contrast
- Exclusion: for matched healthy controls; KPS<70, Past radiation or surgical therapy to the index lesion or the newly diagnosed, Primary germ cell tumor, small cell carcinoma, or lymphoma.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT04365374
Principal Investigator
Simon Hanft, MD
Contact for Study Screening
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Eligibility
- Male or female, between 18 and 89 years of age at the time of procedure
- Angiographic confirmation of LVO of the internal carotid artery (ICA), middle cerebral artery (MCA; M1 or M2), basilar artery, or vertebral artery
- Used CEREGLIDE™ 71 Intermediate Catheter as the first attempted device for mechanical thrombectomy for the intracranial occlusion in the subject (direct aspiration or co-aspiration) or if a subject had another mechanical thrombectomy device without achieving mTICI 2b or better and continues to have angiographic confirmation of a Large Vessel Occlusion (LVO) in the same vessel.
- Deployment of CEREGLIDE™ 71 Intermediate Catheter
- Exclusion criteria:
- Enrollment in another AIS study with related endpoints
Enrollment Status: Actively enrolling
Principal Investigator
Fawaz Al-Mufti, MD
Contact for Study Screening
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Eligibility
- Male or female, Age 18-75 years
- Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as per the approved indication
- Tigertriever was used as the first line treatment in the target vessel
- No known significant pre-stroke disability (pre-stroke mRS 0 or 1)
- Exclusion criteria:
- Use of any other IA recanalization device prior to the Tigertriever in the target vessel, including aspiration catheter
- Evidence of acute brain hemorrhage on CT and/or MRI at admission
- Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months
- Probable cerebral amyloid angiopathy
- Pre-stroke diagnosed dementia and/or prescribed cholinesterase inhibitors
- Pre-stroke diagnosed and/or currently treated major depression
- Pre-stroke learning or intellectual disability
- Anticipated inability to obtain 6-month follow-up assessments
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05531461
Principal Investigator
Chirag Gandhi, MD
Contact for Study Screening
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Eligibility
- Male or female, Age 40-90 years inclusively.
- Per CT of the head, (one of the following): Unilateral convexity CSDH measuring at least 10 mm in thickness OR Bilateral CSDH if only one side is considered for treatment and the contralateral side is asymptomatic and < 5 mm in thickness.
- CSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying CSDH.
- Qualifying baseline head CT performed within the 7 days prior to randomization.
- Able to undergo assigned treatment within 72 hours after randomization.
- Patient or legally authorized representative agrees to be randomized, and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Exclusion criteria:
- Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor.
- Tentorial or interhemispheric SDH.
- Previous craniotomy for the treatment of CSDH if the craniotomy exceeds 7 cm at the maximal dimension on the baseline CT.
- Secondary to CSDH, MRC of 0, 1, 2, or 3 in any muscle group contralateral to the side of the CSDH 4.
- Pre CSDH mRS of 5 or higher.
- Secondary to CSDH, patient is unable to complete TUG (i.e.,TUG > 120 seconds, unable to walk, or tries TUG but quits in ≤ 120 seconds). Note: This criterion does not apply if the patient does not complete TUG for reason other than CSDH.
- Secondary to CSDH, ASR of 0, 1, or 2.
- Emergent surgical evacuation such as open craniotomy, burr hole drainage, or Subdural Evacuating Port System (SEPS) is required for the patient.
- Unable to withhold all antiplatelet agents or OACs for the first 7 days after randomization.
- Indication that withdrawal of care will be implemented for the qualifying SDH.
- Prior surgical treatment for CSDH if the surgery is less than 30 days prior to randomization.
- On tranexamic acid.
- Platelet count of <100,000 per microliter refractory to transfusion.
- Coagulopathy that cannot be corrected to an INR of ≤1.5.
- Known contraindications to angiography.
- Known intolerance to occlusion procedures.
- Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or embolic agent (Embosphere Microspheres or CONTOUR particles) injection.
- Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization.
- Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses (where study embolization devices could pass directly into the internal carotid artery, vertebral artery, or intracranial vasculature) that cannot be addressed with coil embolization.
- Patient has a known active systemic infection or sepsis.
- Patient is pregnant, planning to become pregnant, or lactating.
- Life expectancy of less than 6 months due to comorbid terminal conditions.
- Concurrent participation in another research protocol for investigation of an experimental therapy.
- No measurable deficit on the Timed Up and Go [TUG]31, Aphasia Severity Rating [ASR]32, or MRC.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06347796
Principal Investigator
Chirag Gandhi, MD
Contact for Study Screening