Phase
Condition
Joint Injuries
Inflammation
Treatment
Active tcVNS
Active tcVNS or Sham tcVNS
Sham tcVNS
Clinical Study ID
Ages 5-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant is 5 through 18 years of age (inclusive) at screening.
Regarding informed consent and compliance:
If 5 through 6 years of age, the participant's guardian is willing and able tounderstand and provide informed consent and comply with study protocol.
If 7 through 17 years of age, the participant is willing and able to signassent and comply with study protocol, and the participant's guardian iswilling and able to understand and provide informed consent and comply withstudy protocol.
If 18 years of age, the participant is willing and able to understand andprovide informed consent and comply with study protocol.
The participant has a Juvenile Idiopathic Arthritis (JIA) diagnosis meetingInternational League of Associations for Rheumatology (ILAR) classification criteriawith one of the following subtypes:
rheumatoid-factor negative polyarthritis
rheumatoid-factor positive polyarthritis
persistent oligoarthritis
extended oligoarthritis
psoriatic arthritis
enthesitis-related arthritis
systemic arthritis
The participant has >=3 joints with active arthritis at screening
If the participant is receiving therapy for JIA at screening, that therapy is stablefor the time period outlined below and is expected to remain stable for the durationof the study: a. stable dose for at least 1 week prior to screening: i. Oral steroids, <= 0.2 mg/kg/day with a maximum 10 mg/day dose b. stable dose for at least 2 weeks prior to screening: i. NSAIDs c. stable dose for at least 8 weeks prior to screening: i. adalimumab ii. anakinra iii. canakinumab iv. certolizumab pegol v. etanercept vi. golimumab vii. infliximab viii. leflunomide ix. methotrexate x. tocilizumab d. stable dose for at least 12 weeks prior to screening: i. abatacept
If a female of child-bearing potential, the participant has a negative urinepregnancy test at screening
If of reproductive potential, must agree to abstinence or effective methods of birthcontrol for the duration of the study
Exclusion
Exclusion Criteria:
Other than NSAIDs or intra-articular injections, participant has been treated forJIA with lack of efficacy with:
More than 2 different classes of therapies, or
More than 3 medications in total
Participant has received high-dose steroids (>=0.2 mg/kg/day) within the 28 daysprior to screening.
Participant has had active systemic disease (fever, systemic rash) within the 3months prior to screening including any of the following lab manifestations atscreening:
Ferritin >1000 ng/mL
White blood cell (WBC) ≥15,000/mm^3
Participant has had an active acute systemic infection within 2 weeks of screening.involving fever (100.4⁰F or higher) for more than 24 hours, requirement for systemicantibiotics or antivirals, GI symptoms lasting 48 hours or more, or the need to holdsecond line medications for JIA (methotrexate or biologic).
Participant has a history of arrhythmia.
Participant has been diagnosed with postural orthostatic tachycardia syndrome (POTS).
Participant has received an intra-articular cortisone injection within the 28 daysprior to screening.
Participant has received treatment with an investigational drug or device during the 28 days prior to screening or within five half-lives of the investigational drugprior to screening/baseline, whichever is the greater length of time.
Participant has received chronic treatment with an anti-cholinergic medication,including over the counter medications.
Participant has received treatment with rituximab:
Within one year of screening
At any time previously without documented B cell repletion
Participant has a comorbid disease that has required treatment with corticosteroidswithin the past year.
Participant has an implantable electronic device such as a pacemaker, defibrillator,hearing aid, cochlear implant, insulin pump or deep brain stimulator.
Participant has used cutaneous vagus nerve stimulation within 12 weeks prior toscreening.
Participant has received a live attenuated viral vaccine within 28 days prior toscreening or is expected to receive one during the study.
Participant has any condition which, in the opinion of the investigator, wouldjeopardize the participant's safety following exposure to a study intervention.
Participant has any past or current medical problems or findings from a physicalexamination or laboratory testing that are not listed above but which, in theopinion of the investigator, may pose additional risks from participation in thestudy, may interfere with the participant's ability to comply with studyrequirements, or may impact the quality or interpretation of the data obtained fromthe study.
Study Design
Study Description
Connect with a study center
University of California San Francisco
San Francisco, California 94158
United StatesSite Not Available
University of California San Francisco
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available
University of California San Francisco School of Medicine: Department of Pediatrics, Division of Pediatric Rheumatology
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available
Nemours Children's Health: Department of Pediatric Rheumatology
Orlando, Florida 32827
United StatesSite Not Available
Nemours Children's Health: Department of Pediatric Rheumatology
Orlando 4167147, Florida 4155751 32827
United StatesSite Not Available
Emory University, Children's Healthcare of Atlanta- Center for Advanced Pediatrics: Division of Rheumatology
Atlanta, Georgia 30329
United StatesSite Not Available
University of Chicago, Comer Children's Hospital
Chicago, Illinois 60637
United StatesSite Not Available
Indiana University
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana University
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
Indiana University Medical Center: Riley Hospital for Children Department of Pediatric Rheumatology
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
Cohen Children's Medical Center, Northwell Health
Lake Success, New York 11040
United StatesSite Not Available
Hassenfield Children's Hospital at NYU Langone
New York, New York 10016
United StatesSite Not Available
Hospital for Special Surgery
New York, New York 10021
United StatesSite Not Available
Stephen D. Hassenfield Children's Center at NYU Langone Health
New York, New York 10016
United StatesSite Not Available
Cohen Children's Medical Center, Northwell Health
Lake Success 5123853, New York 5128638 11040
United StatesSite Not Available
Feinstein Institutes for Medical Research, Cohen Children's Medical Center: Pediatric Rheumatology
Lake Success 5123853, New York 5128638 11040
United StatesSite Not Available
Stephen D. Hassenfield Children's Center at NYU Langone Health
New York 5128581, New York 5128638 10016
United StatesSite Not Available
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
University of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Division of Pediatric Rheumatology at the University of Utah School of Medicine and Primary Children's Hospital
Salt Lake City, Utah 84132
United StatesSite Not Available
Division of Pediatric Rheumatology at the University of Utah School of Medicine and Primary Children's Hospital
Salt Lake City 5780993, Utah 5549030 84132
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105
United StatesSite Not Available
Seattle Children's Hospital: Rheumatology Clinic
Seattle 5809844, Washington 5815135 98105
United StatesSite Not Available
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