Ignite Creation Date:
2024-05-06 @ 1:53 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01924780
Status:
UNKNOWN
Last Update Posted:
2013-09-09
First Post:
2013-08-12
Brief Title:
NEMOS in Normal Volunteer and JIA Study
Sponsor:
Karin Palmblad
Organization:
Astrid Lindgren Childrens Hospital
Study Overview
Official Title:
Evaluation of the Anti-inflammatory Potential of NEMOS Transcutaneous Vagus Nerve Stimulation Device in Patients With Juvenile Idiopathic Arthritis
Status:
UNKNOWN
Status Verified Date:
2013-09
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 clincialtrialsgov in order to keep accuracy All details below concerns only Stage A
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 clincialtrialsgov in order to keep accuracy All details below concerns only Stage A
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None