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NEMOS in Normal Volunteer and JIA Study

NCT ID: NCT01924780

Last Updated: 2013-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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The vagus nerve mediates the "inflammatory reflex"; a mechanism the central nervous system utilizes to regulate innate and adaptive immunity (Andersson, 2012). The afferent arm of the reflex senses inflammation both peripherally and in the central nervous system, and down-regulates the inflammation via efferent neural outflow. The efferent arm of this reflex has been termed the "cholinergic anti-inflammatory pathway" (CAP). The reflex serves as a physiological regulator of inflammation by responding to environmental injury and pathogens with an appropriate degree of immune system activation An increasing body of evidence indicates that the CAP can also be harnessed to reduce pathological inflammation. Electrical neurostimulation of the vagus nerve (VNS) with either a surgically implantable device, or alternatively using a non-invasive device that stimulates the auricular branch of the vagus nerve (ABVN) may be a feasible means of modulating diseases characterized by excessive and dysregulated inflammation.

Conditions

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Inflammatory Response

Keywords

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Dose-Response Relationship, Immunologic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NEMOS device stimulation 10 minutes

Subject will be stimulated in the cymba concha with a vibro-tactile mechanical device for 10 minutes

Group Type ACTIVE_COMPARATOR

Stimulation 10 minutes

Intervention Type DEVICE

NEMOS transvagal stimuli 10 minutes

NEMOS transvagal stimulation 60 minutes

Intervention Type DEVICE

NEMOS Device stimulation in 60 minutes

NEMOS Device sham stimulation 10 minutes

Intervention Type DEVICE

NEMOS device 60 minutes stimulation

Subjects will be stimulated in the cymba concha with a vibro-tactile mechanical device for 60 minutes

Group Type ACTIVE_COMPARATOR

Stimulation 10 minutes

Intervention Type DEVICE

NEMOS transvagal stimuli 10 minutes

NEMOS transvagal stimulation 60 minutes

Intervention Type DEVICE

NEMOS Device stimulation in 60 minutes

NEMOS Device sham stimulation 10 minutes

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

Stimulation 10 minutes

Intervention Type DEVICE

NEMOS transvagal stimuli 10 minutes

NEMOS transvagal stimulation 60 minutes

Intervention Type DEVICE

NEMOS Device stimulation in 60 minutes

NEMOS Device sham stimulation 10 minutes

Intervention Type DEVICE

Interventions

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Stimulation 10 minutes

NEMOS transvagal stimuli 10 minutes

Intervention Type DEVICE

NEMOS transvagal stimulation 60 minutes

NEMOS Device stimulation in 60 minutes

Intervention Type DEVICE

NEMOS Device sham stimulation 10 minutes

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Karin Palmblad

OTHER

Sponsor Role lead

Responsible Party

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Karin Palmblad

M.D. PhD Senior scientist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ulf Andersson, Professor

Role: STUDY_CHAIR

Department of Women´s and Children´s Health | Karolinska Institutet

Locations

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Astrid Lindgrens Childrens Hospital, Karolinska University Hospital,

Stockholm, Solna, Sweden

Site Status

Astrid Lindgren University Hospital

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NEMOS1

Identifier Type: -

Identifier Source: org_study_id