Northwestern University Feinberg School of Medicine

Department of Neurological Surgery

Clinical Trials

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.

Neuro-Oncology

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.

Trials
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
Rosenow, Joshua MRosenow, Joshua M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01719055 STU00083506
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Amidei, Christina 312 695 9124
Precision Retrospective Outcomes (PRO)
This study will evaluate deidentified (anonymous) data in subject medical charts to review the clinical outcomes of spinal cord stimulation.
Inclusion Criteria:
-Previously treated with or eligible for implantation with a spinal cord stimulation system
-18 years of age or older at the start of Baseline
Rosenow, Joshua MRosenow, Joshua M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01550575 STU00094644
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Amidei, Christina 312 695 9124
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
Rosenow, Joshua MRosenow, Joshua M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01839396 STU00094646
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Amidei, Christina 312 695 9124
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.
Smith, ZacharySmith, Zachary
  • Map it 201 E. Huron St.
    Chicago, IL
STU00099367
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Amidei, Christina 312 695 9124
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.
Inclusion Criteria:
-Veteran of any combat era
-Both Genders
-20-65 years
-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.

Exclusion Criteria:
-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
Pape, Theresa L Bender LPape, Theresa L Bender L
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02366754 STU00103966
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Amidei, Christina 312 695 9124
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.
Inclusion Criteria:
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.

Exclusion Criteria:
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.
Chandler, James PChandler, James P
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02546102 STU00202704
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Amidei, Christina 312 695 9124
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
-Bleeding disorder
-History of valvular heart disease
-Confounding central nervous system injuries and disorders
-History of recurrent skin infections
Rosenow, Joshua MRosenow, Joshua M
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01996254 STU00202359
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Amidei, Christina 312 695 9124
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.
Inclusion Criteria:

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.
Exclusion Criteria:

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.
Cybulski, George RCybulski, George R
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02669849 STU00203754
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Amidei, Christina 312 695 9124
A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Traumatic Brain Injury (TBI)
The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on p…
The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of intracranial administration of SB623 cells on disability parameters and 2) to evaluate the safety and tolerability of intracranial administration of SB623 cells. Patients with stable, chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.
Inclusion Criteria:
•Documented history of TBI, with correlated MRI or CT
•At least 12 months post-TBI
•Focal cerebral injury able to be identified on MRI (+/- concomitant diffuse axonal injury)
•Neurological motor deficit substantially due to focal cerebral injury observed on MRI
•GOS-E score of 3-6 (i.e. moderate or severe disability)
•Require Motricity Index 10-81 (UE Scale) and/or 10-78 (LE Scale)
•Able and willing to undergo computed tomography (CT) and magnetic resonance imaging (MRI)
•Subjects must be willing to participate in study related exercises to the extent possible
•Able to undergo all planned neurological assessments
Exclusion Criteria:
•History or presence of any other major neurological disease
•Any seizures in the prior 3 months
•The presence of contracture at any joints that would interfere with interpretation of any of the neurological assessments (e.g. contracture preventing the detection of any increase in the range of motion or ability to perform a task)
•Other neurologic, neuromuscular or orthopedic disease that limits motor function
•Clincially significant finding on MRI of brain not related to TBI
•Known presence of any malignancy except squamous or basal cell carcinoma of the skin
•History of CNS malignancy
•Positive findings on tests for occult malignancy, unless a non-malignant etiology is confirmed
•Uncontrolled systemic illness, including, but not limited to: hypertension (systolic >150 mm Hg or diastolic >95 mm Hg); diabetes; renal, hepatic, or cardiac failure
•Uncontrolled major psychiatric illness, including depression symptoms (CESD-R Scale of ≥16)
•Unexplained abnormal preoperative test values (blood tests, electrocardiogram [ECG], chest X-ray); x-ray evidence of infection; uncontrolled atrial fibrillation or uncontrolled congestive heart failure
•Presence of craniectomy (without bone flap replacement) or other contraindication to stereotactic surgery
•Participation in any other investigational trial within 4 weeks of initial screening or within 7 weeks of study entry
•Botulinum toxin injection, phenol injection, intrathecal baclofen, or any other interventional treatments for spasticity (except bracing and splinting) 16 weeks priot to the Baseline visit.
•Ongoing use of other non-traditional drugs
•Substance use disorder (per DSM-V criteria, including drug or alcohol)
•Contraindications to head CT or MRI
•Pregnant or lactating
•Female patients of childbearing potential unwilling to use an adequate birth control method during the 12 months of the stu
Rosenow, Joshua MRosenow, Joshua M
NCT02416492 STU00202886
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Amidei, Christina 312 695 9124
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.
Inclusion Criteria:
•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

Exclusion Criteria:
•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
Lesniak, MaciejLesniak, Maciej
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03072134 STU00203933
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Amidei, Christina 312 695 9124