Northwestern University Feinberg School of Medicine
Department of Neurological Surgery
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Clinical Trials

Scientists at the medical school are conducting hundreds of clinical trials daily. Learn more about our work via the Feinberg Office of Research Clinical Trials page, and find specific trials by searching for a disease or condition below.

For pediatric clinical trials, visit the Ann & Robert H. Lurie Children's Hospital of Chicago website.

For more information on neuro-oncology clinical trials, visit the Robert H. Lurie Comprehensive Cancer Center of Northwestern University website.

Chris Amidei, Director of Clinical Research 312-695-9124Please contact Chris Amidei, Director of Clinical Research at 312-695-9124 or christina.amidei@nm.org for more information on trials.

 
Trials

A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage (MIND)

This study addresses a type of bleeding in the brain called an intracerebral hemorrhage (ICH). This is a serious medical condition and the rate of death resulting from it is very high. Many of those who survive are disabled. The amount of brain injury seems to be related to the …
This study addresses a type of bleeding in the brain called an intracerebral hemorrhage (ICH). This is a serious medical condition and the rate of death resulting from it is very high. Many of those who survive are disabled. The amount of brain injury seems to be related to the size of the blood clot that forms in the head from the bleeding. The purpose of this study is to better understand how well and how safely the Artemis Neuro Evacuation Device (Artemis Device) impacts patients that have bleeding in their brain and compare that with patients who are not treated with the Artemis Device. The Artemis Device, used with the Penumbra Aspiration Pump, is designed to help remove blood and blood clots from the brain. This study will help to determine if more patients survive and have a better recovery after removing an ICH than if it wasn’t done.

The Artemis Device is a medical device that has been cleared by the United States Food and Drug Administration (FDA) for controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in combination with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration System. The device is commercially available in the United States.

Patients with bleeding in the brain causing a type of stroke (intracerebral hemorrhage or ICH) may be eligible for this study.

Jahromi, Babak SJahromi, Babak S
  • Map it 259 E. Erie St. Nineteenth Floor
    Chicago, IL
  • Map it 251 E. Huron St. Fifth Floor, Suite 704
    Chicago, IL
  • Map it 25 N. Winfield Road Suites 424 and 431
    Winfield, IL
  • Map it 25 N. Winfield Road
    Winfield, IL
NCT03342664 STU00209486
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(xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain Metastases

The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients such as you. Researchers have looked at the DNA material (genes) that can be affected in brain metastases and have found several genes that are altered, or mutated. There are medications that target these genes.

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your metastatic cancer. The usual approach is defined as care most people get for your metastatic cancer.

  • Participantsmust be 18 years or older

  • Participants must have a confirmed diagnosis of cancermetastasized to the brain
Kumthekar, Priya UKumthekar, Priya U
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03994796 STU00211229
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Phase 1/2 trial of blood-brain barrier opening with the SonoCloud-9 implantable ultrasound device and treatment with albumin-bound paclitaxel in patients with recurrent glioblastoma

Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be …

Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be implanted at the end of the procedure. In phase 1, about two weeks after surgery, patients will undergo sonication and albumin-bound paclitaxel administration with MRI to quantify extent of blood brain barrier opening. Sonication and administration of albumin-bound paclitaxel will continue every 3 weeks until disease progression. The planned albumin-bound paclitaxel starting dose is 40 mg/m2, to be escalated in the absence of significant toxicity up to 260 mg/m2. Blood samples for circulating tumor DNA will also be collected before and after each sonication. In phase 2, pre-sonication carboplatin at AUC 5 will be added to the regimen, with a safety run-in for the first 6 patients.

Inclusion Criteria:

  • Confirmed diagnosis of Isocitrate Dehydrogenase 1 (IDH1) wild-type glioblastoma on pathology from initial surgery (e.g. IDH R132H neg); morphologic or molecular determination of grade 4
  • Ability to undergo contrast-enhanced MRI
  • Radiographic evidence of tumor recurrence/progression after failure of 1 - 2 lines of prior therapy
  • Measurable or evaluable disease

  • Measurable: contrast-enhancement (bidirectional diameters ≥ 1cm) on MRI
  • Non-measurable/evaluable: contrast-enhancement diameters < 1 cm
  • Maximal tumor diameter pre-surgery ≤ 70 mm on T1wMRI
  • Candidate for at least partial surgical resection
  • Greater 12 weeks from completion of radiation therapy
  • Age ≥ 18 years
  • If receiving dexamethasone for mass effect, a stable daily dose of dexamethasone at < 6 mg within 7 days of registration, or if dexamethasone dose is decreasing, average daily dose of < 6 mg in the 7 days prior to registration. Patients on dexamethasone for reasons other than mass effect may still be enrolled.
  • WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) of ≥70)
  • Adequate hepatic, renal and bone marrow function, documented with normal laboratory values or no more than grade 1 outside the norm performed within 14 days prior to registration
  • For patients with a childbearing potential

  • Negative pregnancy test within 14 days prior to registration
  • Agreement to use adequate contraception for the duration of study participation, and for 3 and 6 months after the last dose of albumin-bound paclitaxel for men and women of childbearing potential, respectively.
  • Have the ability to understand and the willingness to sign a written informed consent prior to registration on study
  • Be willing and able to comply with the protocol for the duration of the study
  • Provide written, signed and dated informed consent prior to study registration. NOTE: no study-specific screening procedures may be performed until written consent has been obtained
  • Exclusion Criteria:

  • Have multifocal disease that cannot be encompassed in the ultrasound fields:

  • e.g. > 70-mm apart
  • tumor located in the posterior fossa
  • Patients at risk of cranial wound dehiscence
  • Have uncontrolled epilepsy or require treatment with enzyme-inducing antiepileptics
  • Have clinical evidence of peripheral neuropathy on examination
  • Have received any other investigational agents within 4 weeks of registration
  • Have received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin
  • Medical contraindications to Abraxane® or carboplatin
  • Have an uncontrolled intercurrent illness
  • Are pregnant or nursing
  • Have a history of active malignancy within 3 years prior to registration.
  • Have a known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Definity® (the FDA-approved ultrasound contrast agent to be used in this study)
  • Patients with coils, clips, shunts, intravascular stents, and/or non-removable wafer, non resorbable dura substitute, or reservoirs.
  • Patients with medical need to continue antiplatelet therapy.
  • Patients with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome (patient at risk for microbubble reaction).
  • Patients with impaired thermo-regulation or temperature sensation (due to device)
  • Sonabend Worthalter, Adam MendelSonabend Worthalter, Adam Mendel
    • Map it 675 N. Saint Clair St. Twentieth Floor
      Chicago, IL
    NCT04528680 STU00212298
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    NU MSK20C04: PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy with Clindamycin and Triamcinolone in Glioblastoma Patients Treated with Tumor Treating Fields

    Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion …

    Studyparticipants are being treated with Tumor Treating Fields (TTFields) formalignant glioma. The TTFields device uses low-intensity electrical fields totreat cancer, and this type of therapy can cause skin side effects, such asitching, sores, or infections. Researchers want to know if using clindamycingel and triamcinolone topical (on the skin) lotion before these side effectsoccur may be able to prevent their appearance, so that TTFields can be usedwith less need for interruptions

    Key eligibility criteria include:

    • Diagnosis of newly diagnosed GBM or any malignant glioma with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution
    • Able to self-administer topical interventions or has available another person who can apply the topical agents
    • Treatment with TTF should be initiated within 7 days of planned initiation in this trial
    • Age of at least 18 years old

    All prospective patients will undergo screening tests to determine if they are eligible to take part in the study.

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 201 E. Huron St.
      Chicago, IL
    NCT04469075 STU00213944
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    NU NCI 20C06: Phase II Trial of the Immune Checkpoint Inhibitor Nivolumab in Patients with Recurrent Select Rare CNS Cancers

    Background:More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an …

    Background:

    More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an effective treatment for people with rare CNS tumors.

    Objectives:

    To learn if stimulating the immune system using the drug nivolumab can shrink tumors in people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors to grow or spread.

    Eligibility:

    Adults whose rare CNS tumor has returned.

    Design:

    Participants will be screened:

    • Heart and blood tests
    • Physical and neurological exam
    • Hepatitis tests
    • Pregnancy test
    • MRI. They will lay in a machine that takes pictures.
    • Tumor tissue sample. This can be from a previous procedure.

    At the start of the study, participants will have blood tests. They will answer questions about their symptoms and their quality of life.

    Participants will get nivolumab in a vein every 2 weeks for up to 64 weeks.

    Participants will have monthly blood tests. Every other month they will have an MRI and a neurologic function test. They will also answer questions about their quality of life.

    Genetic tests will be done on participants' tumor tissue. Participants will be contacted if any clinically important results are found.

    After treatment ends, participants will be monitored for up to 5 years. They will have a series of MRIs and neurological function tests. They will be asked to report any symptoms they experience....

    • INCLUSION CRITERIA:

    • Histopathologically proven diagnosis of Ependymoma, Medulloblastoma, Parenchymal Pineal Region Tumors (Pineoblastoma, Pineocytoma, Pineal Tumor of Intermediate Differentiation, Papillary Tumor of the Pineal Region), Choroid Plexus Tumors (Carcinoma, Papilloma, Atypical Papilloma), Histone Mutated Gliomas, Gliomatosis Cerebri, ATRT, Malignant/Atypical Meningioma*, Gliosarcoma or Primary CNS Sarcoma, Pleomorphic Xanthoastrocytoma (PXA) and Anaplastic Pleomorphic Xanthoastrocytoma (APXA), and tumors formerly known as Primitive Neuro-Ectodermal Tumors (Embryonal Tumor with Multilayered Rosettes, Medulloepithelioma, CNS Neuroblastoma, CNS Ganglioneuroblastoma, CNS Embryonal Tumor NOS; and tumor entities emerging from methylation profiling of CNS-PNETs: CNS neuroblastoma with FOXR2 activation, CNS Ewing sarcoma family tumor with CIC alteration, CNS high-grade neuroepithelial tumor with MN1 alterations, and CNS high-grade neuroepithelial tumor with BCOR alteration) prior to registration.

      *Patient with extra CNS metastases from meningioma will be eligible even if pathology review fails to demonstrate high grade features on available tumor samples.

    • The tumor tissue (e.g. block or 20 unstained slides) must be available to be sent for immunophenotyping.
    • Participants must have progressive tumor growth after having received established standard of care and/or other experimental treatments for their newly diagnosed or recurrent disease. Participants will be enrolled into 2 different cohorts (cohort 1 or heavily pretreated; cohort 2 or not heavily pretreated
    • Age greater than or equal to 18;
    • Karnofsky performance status (Bullet) 70 within 14 days prior to Step 2 registration; Participants with severe paraparesis/paraplegia who need minimal assistance for selfcare due to their motor deficit but are otherwise functionally independent will be considered eligible.
    • Adequate hematologic function based on CBC/differential within 14 days prior to Step 2 registration defined as follows:

      • Absolute neutrophil count greater than or equal to 1,500 cells/mm3;
      • Platelet count greater than or equal to 100,000 cells/mm3
      • Hemoglobin > 9.0 g/dl (may be transfused to achieve this level)
    • Adequate renal function within 14 days prior to Step 2 registration defined as follows:

      • BUN less than or equal to 30 mg/dl and
      • Serum creatinine less than or equal to 1.7 mg/dl

      Note: If the serum creatinine is greater than 1.7 mg/dl, a 24-hour urine creatinine clearance will be obtained and if the result of this study is within normal limits*, the patient would be eligible to enroll onto study. (*Normal Creatinine Clearance Range: Male: 90 - 130 ml/min; Female: 80 - 125 ml/min)

    • Adequate hepatic function within 14 days prior to Step 2 registration defined as follows:

      • Total bilirubin (except patients with Gilbert s Syndrome, who are eligible for the study but exempt from the total bilirubin eligibility criterion) less than or equal to 2.0 mg/dl and
      • ALT and AST less than or equal to 2.5x ULN
      • No active or chronic hepatitis infection. HCV antibody (for Hepatitis C) and Hepatitis B Surface antigen and Hepatitis B core antibody must be negative. This has been routinely incorporated into immunotherapy trials with checkpoint inhibitors because of concerns that the risk of treatment-induced hepatic injury is increased in the setting of active viral hepatitis.
    • The patient must not be on a corticosteroid dose greater than physiologic replacement dosing defined as 30 mg of cortisone per day or its equivalent.
    • The patient must provide study-specific informed consent prior to study entry. No Durable Power of Attorney or Next of Kin can provide initial consent.

      2.1.1.10 Participants must meet the below requirements regarding COVID-19 Status:

      2.1.1.10.1 Participants must be fully vaccinated for coronavirus disease 2019 (COVID-19) as defined by the Center for Disease Control guidance for patients who are immunocompromised. Participants must have received required vaccination(s) by the time of Step 2 registration and be considered fully immunized (typically 2 weeks after final vaccination) by the time of the initiation of treatment.

      2.1.1.10.2 Participants must have a negative COVID-19 test within 72 hours of the first dose of study drug. Patients who had documented COVID-19 infection within 90 days of treatment but are more than 20 days from infection do not need to be tested and are eligible if they fulfill the eligibility requirement regarding adequate vaccination.

      2.1.1.10.3 Vaccinated participants must agree to follow current guidance to protect themselves from exposure to COVID-19, such as wearing masks, social distancing, and maintaining good hand hygiene even after vaccination.

    • The effects of nivolumab on the developing human fetus are unknown. For this reason, women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.

    NOTE: Based on the evidence cited in Nivolumab IB ver. 20, given that nivolumab is not a genotoxic agent, and that relevant systemic concentrations sufficient to produce a risk of fetal toxicity are not expected in WOCBP partners from exposure to a male participant s seminal fluid, male study participants will not be required to use contraceptive measures and/or a latex or other synthetic condom during sexual activity with a WOCBP partner.

    EXCLUSION CRITERIA:

  • Patients who are receiving any other investigational agents.
  • Prior use of an immunotherapy such as (but not limited to) a vaccine therapy, dendritic cell vaccine, other checkpoint inhibitors, or intracavitary or convectional enhanced delivery of chemotherapy.
  • Prior or concurrent malignancy unless its natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Severe, active co-morbidity defined as follows:

    Unstable angina within the last 6 months prior to Step 2 registration.

    Transmural myocardial infarction within the last 6 months prior to Step 2 registration

    Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of (Bullet) 2 mm using the analysis of an EKG performed within 14 days prior to Step 2 registration.

    New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to Step 2 registration.

    History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months prior to Step 2 registration, with the exception of pericavitary ischemia due to tumor resection.

    Serious and inadequately controlled cardiac arrhythmia.

    Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.

    Evidence of bleeding diathesis or coagulopathy.

    Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Step 2 registration, with the exception of the craniotomy for tumor resection.

    Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.

    Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.

    Known acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude participants with AIDS is based on the lack of information regarding the safety of nivolumab in patients with active HIV infection.

    Active connective tissue disorders, such as lupus or scleroderma, which in the opinion of the treating physician may put the patient at high risk for immunologic toxicity.

  • Participants with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to participants with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome or CIDP, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn s, ulcerative colitis, hepatitis; and participants with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease.

    --Of note, participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Participants with rheumatoid arthritis and other arthropathies, Sj(SqrRoot)(Delta)gren s syndrome and

    psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. However, patients with vitiligo, diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolled.

  • Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
  • Allergies and Adverse Drug Reaction: History of allergy to study drug components
  • Pregnancy or lactating females due to possible adverse effects on the developing fetus or infant due to study drug. Women of childbearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to Step 2 registration.
  • History of severe hypersensitivity reaction to any monoclonal antibody.
  • 10. Participants with contraindications to COVID-19 vaccination will not be eligible.

    11. Participants unable to have MRIs.

    Kumthekar, Priya UKumthekar, Priya U
    • Map it 420 E. Superior St.
      Chicago, IL
    NCT03173950 STU00214301
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    NRG BN012

    This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in …

    This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Some of the eligibility criteria include:

    · Radiographic confirmation of 1-4 brain metastases

    · Participants must be 18 or older

    · Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years cancer based on documented pathologic diagnosis within the past 3 years

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Magill, Stephen T.Magill, Stephen T.
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    NCT05438212 STU00218228
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    RESET-RA

    This study will evaluate the safety and effectiveness of the SetPoint Medical System (study device) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA), who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).…

    This study will evaluate the safety and effectiveness of the SetPoint Medical System (study device) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA), who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).

    Inclusion Criteria:

    • 22-75 years of age at screening
    • Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints
    • Demonstrated an inadequate response, loss of response, or intolerance to 1 or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors (JAKi)
    • Receiving treatment with at least 1 conventional synthetic DMARD for at least 12 weeks and on a continuous non-changing dose and route of administration for at least 4 weeks prior to Screening and able to continue the same stable dose through Week 12

    Exclusion Criteria:

    • Untreated or poorly controlled psychiatric illness or history of substance abuse
    • Significant immunodeficiency due to underlying illness
    • History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia
    • Clinically significant cardiovascular disease
    • Neurological syndromes, including multiple sclerosis, Alzheimer's disease, or Parkinson's disease
    • Uncontrolled fibromyalgia
    • History of left or right carotid surgery
    • History of unilateral or bilateral vagotomy, partial or complete splenectomy
    • Recurrent vasovagal syncope episodes
    • Current, regular use of tobacco products
    Ruderman, Eric MRuderman, Eric M
    • Map it 259 E. Erie St. Nineteenth Floor
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    NCT04539964 STU00213547
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