Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04520516
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2020-08-17
Brief Title:
Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Trial of Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
ESTIVAL
Brief Summary:
Erosive hand osteoarthritis EHOA is a difficult-to-treat subtype of HOA characterized by local and systemic low-grade inflammation as well as by high level of pain and of disability
Auricular transcutaneous vagus nerve stimulation tVNS is a promising therapeutic strategy that may reduce inflammation and pain level
ESTIVAL is a 12 weeks randomized sham-controlled trial investigating the symptomatic efficacy and safety of tVNS in patients with symptomatic and inflammatory EHOA
tVNS will be performed using a transcutaneous electrical nerve stimulation TENS device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve
The active and sham devices will display similar appearance but the sham one will not give electric signal
Auricular transcutaneous vagus nerve stimulation tVNS is a promising therapeutic strategy that may reduce inflammation and pain level
ESTIVAL is a 12 weeks randomized sham-controlled trial investigating the symptomatic efficacy and safety of tVNS in patients with symptomatic and inflammatory EHOA
tVNS will be performed using a transcutaneous electrical nerve stimulation TENS device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve
The active and sham devices will display similar appearance but the sham one will not give electric signal
Detailed Description:
Symptomatic hand osteoarthritis HOA affects 8-16 of the general population above 50 years and involves interphalangeal IP joints HOA symptoms include pain stiffness and are responsible for disability and substantial burden Erosive HOA EHOA 10 prevalence among symptomatic HOA from the general population and 40-50 prevalence in tertiary centers is the most severe HOA phenotype characterized by inflammatory flares more IP joint destruction pain soft swelling joints ie synovitis and more disability similar to rheumatoid arthritis RA than its non-erosive counterpart
Current symptomatic pharmacological treatments of HOA or EHOA have a poor efficacy on pain ie paracetamol or safety issues ie non-steroidal anti-inflammatory drugs NSAIDs in this aging population with frequent comorbidities Systemic and joint inflammation contribute to EHOA but 4 studies using TNF inhibitors 2 using hydroxychloroquine 1 using methotrexate and 1 using a new anti-IL1αβ failed to show any efficacy on pain in HOA or in EHOA Therefore innovative therapeutic approaches are awaited
Stimulation of the vagus nerve VNS 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 VN stimulation VNS by cervical implantable device activating CAP has given promising results in refractory RA patients Beyond its anti-inflammatory effects VNS is analgesic in chronic pain disorders headache fibromyalgia However the use of such implantable device is limited by the need of cervical surgery and subsequent potential side effects
Besides implantable devices VNS may be also performed using transcutaneous VNS tVNS of the ascendant auricular branch of the VN that selectively innervates the cutaneous zone of cymba conchae at the left ear Auricular tVNS avoids invasive neurosurgery and its potential side effects and is less expensive than implantable VNS making it an attractive candidate for neurostimulation Auricular tVNS has given positive results in chronic migraine and is currently tested in RA Crohns disease widespread pain irritable bowel syndrome and musculoskeletal pain related to systemic lupus
We hypothesize 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 ie painful and inflammatory EHOA
ESTIVAL is a 12 weeks randomized sham-controlled trial investigating the symptomatic efficacy and the safety of tVNS in patients with symptomatic and inflammatory EHOA
tVNS will be performed using an active or sham transcutaneous electrical nerve stimulation TENS device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve
Exploratory and ancillary studies will include i changes of serum biomarkers of inflammation and of cartilage degradation that will be assess at inclusion and at week 12 ii hand MRI at W0 and W12 of the most symptomatic joint at inclusion for HOAMRIS socring at W0 and W12 for the center of Saint Antoine
A phone call at D7 3 days by the clinical research technician or the clinical nurse or the doctor who has performed the education during the D0 visit to check the proper use of the device
Current symptomatic pharmacological treatments of HOA or EHOA have a poor efficacy on pain ie paracetamol or safety issues ie non-steroidal anti-inflammatory drugs NSAIDs in this aging population with frequent comorbidities Systemic and joint inflammation contribute to EHOA but 4 studies using TNF inhibitors 2 using hydroxychloroquine 1 using methotrexate and 1 using a new anti-IL1αβ failed to show any efficacy on pain in HOA or in EHOA Therefore innovative therapeutic approaches are awaited
Stimulation of the vagus nerve VNS 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 VN stimulation VNS by cervical implantable device activating CAP has given promising results in refractory RA patients Beyond its anti-inflammatory effects VNS is analgesic in chronic pain disorders headache fibromyalgia However the use of such implantable device is limited by the need of cervical surgery and subsequent potential side effects
Besides implantable devices VNS may be also performed using transcutaneous VNS tVNS of the ascendant auricular branch of the VN that selectively innervates the cutaneous zone of cymba conchae at the left ear Auricular tVNS avoids invasive neurosurgery and its potential side effects and is less expensive than implantable VNS making it an attractive candidate for neurostimulation Auricular tVNS has given positive results in chronic migraine and is currently tested in RA Crohns disease widespread pain irritable bowel syndrome and musculoskeletal pain related to systemic lupus
We hypothesize 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 ie painful and inflammatory EHOA
ESTIVAL is a 12 weeks randomized sham-controlled trial investigating the symptomatic efficacy and the safety of tVNS in patients with symptomatic and inflammatory EHOA
tVNS will be performed using an active or sham transcutaneous electrical nerve stimulation TENS device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve
Exploratory and ancillary studies will include i changes of serum biomarkers of inflammation and of cartilage degradation that will be assess at inclusion and at week 12 ii hand MRI at W0 and W12 of the most symptomatic joint at inclusion for HOAMRIS socring at W0 and W12 for the center of Saint Antoine
A phone call at D7 3 days by the clinical research technician or the clinical nurse or the doctor who has performed the education during the D0 visit to check the proper use of the device
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