Scientists at the medical school are conducting hundreds of clinical trials daily. Learn more about all Feinberg trials via the Feinberg Office of Research Clinical Trials page. The Department of Neurological Surgery has numerous active clinical trials.
Learn more about our work via the Robert H. Lurie Comprehensive Cancer Center Clinical Trials page.
Neurological Surgery Trials
Below are listed a selected list of our active, recruiting protocols. Search or browse to find studies applicable to your needs.
RELIEF: A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (A7007)
The purpose of this study is to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practic…
The purpose of this study is to compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use and to evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice.
Key Inclusion Criteria:
-Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
-Signed a valid, IRB/EC-approved informed consent form
-18 years of age or older
Key Exclusion Criteria:
-Contraindicated for Boston Scientific neurostimulation system
-Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III
A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).
-Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging (CT, CTA, etc.), with a GCS ≤ 14 or a NIHSS ≥ 6.
-Six-hour clot size equal to the most previous clot size (within 5 mL) as determined by additional CT scans at least 6 hours apart using the ABC/2 method.
-Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of onset is exclusionary).
-Ability to randomize between 12 and 72 hours after dCT.
-SBP < 180 mmHg sustained for six hours recorded closest to the time of randomization.
-Historical Rankin score of 0 or 1.
-Age ≥ 18 and older.
-Intraventricular hemorrhage requiring treatment for IVH-related (casting) mass effect or shift due to trapped ventricle. EVD to treat ICP is allowed.
-Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions. Note: Patients with a posterior fossa ICH or cerebellar hematomas are ineligible.
-Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4.
-Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (< 1 year) hemorrhage diagnosed with radiographic imaging. Patients with unstable mass or evolving intracranial compartment syndrome.
-Platelet count < 100,000, INR > 1.4, or an elevated prothrombin time (PT) or activated partial thromboplastin time (aPTT).
-Any irreversible coagulopathy or known clotting disorder.
-Inability to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as but not limited to NovoSeven, FFP, and/or vitamin K).
-Subjects requiring long-term anti-coagulation are excluded. Reversal of anti-coagulation is permitted for medically stable patients who can realistically tolerate the short term risk of reversal. Patient must not require Coumadin (anticoagulation) during the first 30 days, and normalized coagulation parameters must be demonstrated, monitored closely and maintained during the period of brain instrumentation.
-Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
-Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
-Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures, etc.) or site of recent surgical intervention.
-Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization.
-Allergy/sensitivity to rt-PA.
-Prior enrollment in the study.
-Participation in a concurrent interventional medical investigation or clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving an intervention are eligible.
-Not expected to survive to the day 365 visit due to co-morbidities and/or are DNR/DNI status prior to randomization.
-Any concurrent serious illness that would interfere with safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
-Patients with mechanical} heart valve. Presence of bio-prosthetic valve(s) is permitted.
-Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis.
-Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
-Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
-In the investigator's opinion, the patient is unstable and would benefit from a specific intervention rather than supportive care plus or minus MIS+rt-PA removal of the ICH.
-Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Precision Retrospective Outcomes (PRO)
This study will evaluate deidentified (anonymous) data in subject medical charts to review the clinical outcomes of spinal cord stimulation.
-Previously treated with or eligible for implantation with a spinal cord stimulation system
-18 years of age or older at the start of Baseline
Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced,levodopa-responsive bilateral Parkinson's dise…
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced,levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.
22-75 years old; Diagnosis of bilateral, idiopathic Parkinson's disease
Radiographic Markers of Clinical Function in Cervical Spondylotic Myelopathy (CSM)
Cervical spondylotic myelopathy (CSM), also called “spinal stenosis,” is a common cause of injury to the cervical spinal cord (the neck). CSM can cause pain in the neck and arms, as well as weakness and loss of coo…
Cervical spondylotic myelopathy (CSM), also called “spinal stenosis,” is a common cause of injury to the cervical spinal cord (the neck). CSM can cause pain in the neck and arms, as well as weakness and loss of coordination in the neck, arms, hands, legs, and feet. Although CSM is common, there is still a question of how findings on imaging such as x-rays or magnetic resonance imaging (MRI) relate to a person’s symptoms. The purpose of this study is to see how the images and symptoms of people with CSM compare to images of healthy people without CSM. We are looking for healthy volunteers to help us gain valuable insight into how medical imaging can help us diagnose CSM.
Participants must be 21 years of age or older, preferably 40 years of age or older. Participants may not have any previous spine surgeries or chronic neck pain.
rTMS: A Treatment to Restore Function After Severe TBI
The purpose of this study is to address the need for targeted treatments that induce functional and structural changes in the brain, ultimately improving neurobehavioral functioning, the investigators propose examining the therapeutic effectiven…
The purpose of this study is to address the need for targeted treatments that induce functional and structural changes in the brain, ultimately improving neurobehavioral functioning, the investigators propose examining the therapeutic effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS). The objective is to improve functional recovery for persons remaining in vegetative (VS) and minimally conscious (MCS) states 3 to 12 months after severe TBI. The approach is to determine the neurobehavioral effect of rTMS, the relationship between neurobehavioral changes and net neural effects, and to identify and define the neural mechanisms related to neurobehavioral improvements by providing 30 active or placebo rTMS sessions.
-Veteran of any combat era
-History of Post Traumatic Amnesia < 1 day for mild TBI; 1 day> x < 7days for moderate TBI))
-Ability to obtain a Motor Threshold (MT) will be determined during the screening process.
-If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and patient will be willing to remain on a stable regimen during the acute treatment phase.
-Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
-For female participants, agrees to use one of the following acceptable methods of birth control: abstinence, oral contraceptive; Norplant
-Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.
-Pregnant or lactating female.
-Unable to be safely withdraw, at least two-weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures
-Have a cardiac pacemaker or a cochlear implant
-Have an implanted device (deep brain stimulation) or metal in the brain (see standard MRI exclusion criteria including metal screening section in telephone screen, Appendix A).
-Have a mass lesion, cerebral infarct or other active central nervous system (CNS) disease, including a seizure disorder.
-Known current psychosis as determined by DSM-IV coding in chart (Axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder.
-Diagnosis of Bipolar Affective Disorder (as determined by chart review and intake interview)
-Current amnesic disorders, dementia, mini mental state examination (MMSE) 24 or delirium.
-Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by history via AUDIT, within 3 months prior to screening
-Prior history of seizures
-Severe TBI or open head injury
-TBI within last two months or in acute stage
-Participation in another concurrent clinical trial
-Patients with prior exposure to rTMS/ECT
-Active current suicidal intent or plan. Patient at risk for suicide will be required to establish a written safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial
Prospective Multicenter Cohort Study Comparing Extent of Tumor Resection Between Microscopic Transsphenoidal Surgery and Fully Endoscopic Transsphenoidal Surgery for Nonfunctioning Pituitary Adenomas [Transsphenoidal Extent of Resection Study – TRANSSPHER Study]
Endonasal transsphenoidal removal of…
Endonasal transsphenoidal removal of a pituitary tumor is a unique procedure and there is little information comparing the surgical techniques. The purpose of this research is to compare surgical techniques in patients with nonfunctioning pituitary adenomas (tumors that do not change hormone levels in patients). This is an observational, data collection study, which means there will be no experimental procedures or experimental medicines. Your participation in this study has no effect on the type of surgery you will have.
Adult patients with suspected nonfunctional pituitary macroadenomas who have planned transsphenoidal surgery.
-Patients with suspected nonfunctioning pituitary macroadenomas (≥ 1 cm) with planned transsphenoidal surgery
-Adults (age 18-80 years)
-Medically stable for surgery
-Reasonable expectation that patient will complete study and be available for follow-up assessments
*Patients who have had prior surgery are eligible for the study.
-Patients with suspected functioning pituitary adenoma
-Unable to obtain MRI of the pituitary
STING (Study of Immunotherapy in Newly Diagnosed Glioblastoma): A Phase III randomized double-blind, controlled study of ICT-107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy
ICT-107 consists of dendritic cells, prepared …
ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.
1.Subjects must understand and sign the study specific informed consent
2.Subjects must be in primary remission
3.Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks (by central read)
4.Subjects must be HLA-A2 positive by central lab
5.Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
a.Hemoglobin (Hgb) > 8 g/dL
b.Absolute Neutrophil Count (ANC) > 1000/mm3
c.Platelet count > 100,000/mm3
d.Blood Urea Nitrogen (BUN) < 30 mg/dL
e.Creatinine < 2 mg/dL
f.Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
g.Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x unless therapeutically warranted
6.Subjects must use effective contraceptive methods during the study and for three months following the last dose of study product, if of reproductive age and still retain fertility potential.
7.Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.
1.Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia).
2.Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
3.Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
4.Subjects with a history of chronic or acute hepatitis C or B infection.
5.Subjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility.
6.Subjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
7.Subjects with active other malignancy diagnosed in the past 3 years (excepting in situ tumors)
8.Subjects known to be pregnant or nursing.
The INSPIRE Study: In Vivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury
To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12/L1 spinal…
To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12/L1 spinal cord injury.
Key Inclusion Criteria:
Aged 16 - 70 years
AIS A traumatic spinal cord injury at neurological spinal cord level T2-T12/L1
Recent injury (must receive Scaffold within 96 hours from injury)
Non-penetrating contusion injury no less than approximately 4 mm diameter by MRI
Key Exclusion Criteria:
Incomplete spinal cord injury (AIS B, C, D, E)
Spinal cord injury associated with traumatic brain injury
Subject on long term mechanical ventilation
Radiographic or visual evidence of parenchymal dissociation or anatomic transection where the contusion completely bridges a full cross-section of the spinal cord
A Randomized, Double-Blinded, Placebo-Controlled, Multicenter Pilot Study of the SPRINT Peripheral Nerve Stimulation (PNS) System for the Treatment of Post-Amputation Pain
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively redu…
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
Key Inclusion Criteria:
-At least 18 years old
-Traumatic lower extremity amputation(s)
-Healed amputation and healthy residual limb based upon the investigator's evaluation
Key Exclusion Criteria:
-Change of prescribed medications affecting pain within the past 4 weeks
-Compromised immune system based on medical history
-Implanted electronic device
-History of valvular heart disease
-Confounding central nervous system injuries and disorders
-History of recurrent skin infections
A Phase 2b/3, Double-Blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical …
The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific evaluation of the effects of VX-210 on neurological recovery and daily function after spinal cord injury.
Acute traumatic cervical spinal cord injury (SCI), motor level of C4, C5, or C6 on each side (C4 subjects must have at least 1 point of motor activity between C5 and T1 on each side).
American Spinal Injury Association Impairment Scale (AIS) grade A or AIS grade B.
Scheduled and planned to undergo a spinal decompression/stabilization surgery that commences within 72 hours after the initial injury.
Computed tomography (CT) scan or magnetic resonance imaging (MRI) is consistent with the subject's neurological deficit.
Participation in any other clinical study for acute SCI.
Inability to undergo decompression/stabilization surgery that commences within 72 hours after injury.
One or more upper extremity muscle groups untestable during baseline American Spinal Injury Association (ASIA) examination.
Acute SCI from gunshot or penetrating/stab wound; non-traumatic SCI (e.g., transverse myelitis, acute disc herniation); brachial plexus injury; complete spinal cord transection; or multifocal SCI.
Females who are breastfeeding or have a positive serum pregnancy test.
Body mass index (BMI) of ≥40 kg/m2 at screening.
History of an adverse reaction to a fibrin sealant or its components.
Unconsciousness or other mental impairment that precludes reliable International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) examination.
Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs.
Any significant medical or psychiatric comorbidities that would significantly increase the risk of study enrollment and/or significantly interfere with study outcomes or assessments, in the judgement of the investigator.
A PHASE I STUDY OF NEURAL STEM CELL BASED VIROTHERAPY IN COMBINATION WITH STANDARD RADIATION AND CHEMOTHERAPY FOR MALIGNANT GLIOMA
Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Bas…
Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem cell line in combination with radiation and chemotherapy is well-suited for evaluation in newly diganosed malignant gliomas. The standard-of-care allows application of virotherapy as neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy without altering the standard treatment.
•Patients must have presumed malignant glioma based on clinical and radiologic evaluation (pathologic confirmation of malignant glioma must be made at the time of stereotactic biopsy or resection prior to NSC-CRAd-S-pk7 injection; if this is not possible, the injection will not be performed and the subject will no longer be eligible for the study).
•Tumor must be accessible for injection and must not be located in the brainstem, or contained within the ventricular system.
•Planning to undergo standard radiation/chemotherapy
•18 years of age or older.
•Performance status must be KPS ≥ 70
•SGOT (AST) < 3x upper limit of normal
•Serum creatinine < 2mg/dl
•Platelets > 100,000/mm3 and WBC > 3000/mm3
•Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection.
•Immunosuppressive drugs (with exception of corticosteroid).
•Known HIV+ patients.
•Acute infections (viral, bacterial or fungal infections requiring therapy).
•Pregnant or breast-feeding patients.
•Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers).
•Prior radiation therapy to the brain or prior treatment for brain tumor Other serious co-morbid illness or compromised organ function