Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03919279
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2019-04-15
Brief Title:
Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Transcutaneous Auricular Vagus Nerve Stimulation in Erosive Hand Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
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:
ADEPT
Brief Summary:
Erosive hand osteoarthritis EHOA is a subtype of had osteoarthritis characterized by inflammation and pain with subsequent burden Few symptomatic treatments are available in EHOA while this population with EHOA has frequently comorbidities
Stimulation of the vagus nerve VN belonging to parasympathetic system dampens pro-inflammatory cytokines production by splenic macrophages through to the binding of acetylcholine neurotransmitter to α7nicotinic receptor on macrophages this is the cholinergic anti-inflammatory pathway CAP Beyond its anti-inflammatory effects VNS is analgesic in chronic pain disorders headache fibromyalgia Beside implantable devices VNS may be performed using transcutaneous stimulation of the ascendant auricular branch of the VN tVNS at the left ear localized on the cymba conchae tVNS is well-tolerated therapy avoiding invasive neurosurgery
The investigator do the hypothesis that auricular tVNS using a transcutaneous electrical nerve stimulation TENS device could be a novel simple and well-tolerated analgesic and anti-inflammatory treatment of symptomatic EHOA
Stimulation of the vagus nerve VN belonging to parasympathetic system dampens pro-inflammatory cytokines production by splenic macrophages through to the binding of acetylcholine neurotransmitter to α7nicotinic receptor on macrophages this is the cholinergic anti-inflammatory pathway CAP Beyond its anti-inflammatory effects VNS is analgesic in chronic pain disorders headache fibromyalgia Beside implantable devices VNS may be performed using transcutaneous stimulation of the ascendant auricular branch of the VN tVNS at the left ear localized on the cymba conchae tVNS is well-tolerated therapy avoiding invasive neurosurgery
The investigator do the hypothesis that auricular tVNS using a transcutaneous electrical nerve stimulation TENS device could be a novel simple and well-tolerated analgesic and anti-inflammatory treatment of symptomatic EHOA
Detailed Description:
In symptomatic and inflammatory EHOA patients we will apply tNVNS using device from Schwa-Medico TENSeco2 auricular electrode conductive gel 25 Hz stimulation will be applied intensity escalated up to 15 mA or below if tingling sensation
tVNS will be performed 1 hour daily for 1 month and we will assess EHOA symptoms pain and function at 1 month end of the study
tVNS will be performed 1 hour daily for 1 month and we will assess EHOA symptoms pain and function at 1 month end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None