- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01924780
NEMOS in Normal Volunteer and JIA Study
Evaluation of the Anti-inflammatory Potential of NEMOS® Transcutaneous Vagus Nerve Stimulation Device in Patients With Juvenile Idiopathic Arthritis
This will be a two-stage study to test whether t-VNS using the NEMOS device can activate the CAP and reduce markers of systemic inflammation. Stage A (healthy volunteers) stage B (patients with Juvenile Idiopathic Arthritis).
Stage A: healthy human volunteers. A randomized, single blind, three-period crossover design comparing the CAP activation effect of 10 minutes (active) versus 60 minutes (active) versus 10 minutes (sham) stimulation with the NEMOS device. CAP activation will be assessed by reduction in the in vitro release of LPS-inducible cytokines from whole blood.
Analysis of the reduction in whole blood cytokine release assay after 10 versus 60 minutes of stimulation, and the kinetics of the nadir of the whole blood cytokine release assay will inform the selection of dose duration and sampling time for Stage B. Performing this more extensive exploration of dose duration and kinetics in adults will allow one dose, and a single optimal sampling time in the JIA patients, thus minimizing blood drawing and discomfort in these children.
Stage B will be performed in patients with JIA. This will be an open label design examining the effect of the optimal dose duration (either 10 minutes or 60 minutes of stimulation, as determined by results of Stage A). All information regarding Stage B will be registered in a separate registration at clincialtrials.gov. in order to keep accuracy. All details below concerns only Stage A.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Stockholm, Sweden, 17176
- Astrid Lindgren University Hospital
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Solna
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Stockholm, Solna, Sweden, 171 76
- Astrid Lindgrens Childrens Hospital, Karolinska University Hospital,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent
- Males and females ages 18-75, inclusive
- Subjects must be free from any active disease, and must not be on any medication that, in the opinion of the investigator, might compromise the measurement or interpretation of the study biomarkers
- Subjects must be able to attend all study visits
Exclusion criteria:
- Significant psychiatric disease or substance abuse
- Anatomic abnormalities, wounds, significant scars or skin disorders affecting the left pinna or external ear canal which would hinder the safe and proper use of the study device
- History of unilateral or bilateral vagotomy
- History of recurrent vasovagal syncope episodes
- Women who are pregnant or plan to conceive during the study. Women of childbearing potential must be willing to use a reliable form of birth control during the study.
- Known history of cardiac rhythm disturbances, atrioventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block
- Presence of previously implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators), or plans to implant such devices during the course of the study
- Planned use of any other external electrically active medical device during the course of the study (e.g., transcutaneous electrical nerve stimulation [TENS] units)
- Any investigational small molecule drug within 30 days of Day 0, visit investigational monoclonal antibody or soluble receptor within 3 months of Day 0 visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: NEMOS device stimulation 10 minutes
Subject will be stimulated in the cymba concha with a vibro-tactile mechanical device for 10 minutes
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NEMOS transvagal stimuli 10 minutes
NEMOS Device stimulation in 60 minutes
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ACTIVE_COMPARATOR: NEMOS device 60 minutes stimulation
Subjects will be stimulated in the cymba concha with a vibro-tactile mechanical device for 60 minutes
|
NEMOS transvagal stimuli 10 minutes
NEMOS Device stimulation in 60 minutes
|
SHAM_COMPARATOR: Sham 10 minutes
10 minutes of t-VNS stimulation by rotating the NEMOS ear electrode 180 degrees within the pinna, which will position the electrode on the earlobe
|
NEMOS transvagal stimuli 10 minutes
NEMOS Device stimulation in 60 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-inflammatory Pharmacokinetics
Time Frame: 3 months
|
Determine if CAP can be evoked and set the maximum percent change in the in vitro release of LPS-inducible TNF in the whole blood in vitro LPS-inducible cytokine release assay, over the interval from pre-t-VNS to 7 days following t-VNS, comparing sham treatment to each of the two active treatment groups, i.e. 10 minutes and 60 minutes
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-inflammatory response
Time Frame: 3 months
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Determine whether 60 minutes of t-VNS induces greater reduction and/or longer duration of effect than 10 minutes as assessed by the in vitro release of LPS-inducible TNF from whole blood
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3 months
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Anti inflammatory response
Time Frame: 3 months
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-Determine the optimum time point for blood sampling the in vitro release of LPS-inducible TNF from whole blood as assessed by the time of nadir post-stimulation
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3 months
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Anti-inflammatory response
Time Frame: 3 months
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Determine the effect of t-VNS on the in vitro release of LPS-inducible IL-1 and IL-6 from whole blood
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3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ulf Andersson, Professor, Department of Women´s and Children´s Health | Karolinska Institutet
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NEMOS1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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