Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415591
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-08
Brief Title:
Auricular Neuromodulation in Veterans With Fibromyalgia
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Auricular Neuromodulation in Veterans With Fibromyalgia A Randomized Sham-Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
PENFS percutaneous electrical nerve field stimulation is an FDA-cleared acupuncture-like therapy applied to the external ear targeting several cranial nerve branches including the auricular branch of the vagus nerve to improve pain physical function and reduce symptoms of opioid withdrawal PENFS has been previously shown to provide improvements in fibromyalgia a difficult to treat chronic pain syndrome which correlate with changes observed using a special kind of MRI called resting state functional connectivity MRI rs-fcMRI that evaluates brain activity at rest The goals of this study are to rigorously test the initial promising results of PENFS in a much larger group of Veterans suffering from fibromyalgia and to identify potential mechanisms of PENFS effects Further developing non-pharmacologic therapies for pain can help to improve quality of life and function for those suffering from fibromyalgia and decrease reliance on opioids and other drugs that have numerous side effects for individuals suffering from chronic pain
Detailed Description:
BACKGROUND In the setting of the opioid epidemic it is crucial to develop and assess non-pharmacologic treatments for pain and understand underlying mechanisms In the present investigation the investigators assess a novel non-pharmacologic approach to chronic pain treatment in Veterans suffering from fibromyalgia a notoriously difficult to treat pain syndrome that affects 5-10 million Americans and disproportionately affects those returning from the Gulf War utilizing brain imaging as a biomarker and heart rate variability HRV to assess a vagal mechanism Preliminary results from prior VA-funded feasibility study reveal a trend towards improved pain and function with a FDA-approved non-pharmacologic therapy - auricular percutaneous electrical nerve field stimulation PENFS - over standard therapy control for Veterans suffering from fibromyalgia correlating to altered network connectivity on rs-fcMRI resting state functional connectivity MRI PENFS-related improvements continued through 12 weeks following the completion of treatment and correlated to changes in cross-network connectivity which differed between groups Based on the preliminary data the investigators now intend to rigorously assess the treatment effects of PENFS in a large double-blind randomized sham-controlled study
OBJECTIVE The proposed Merit a randomized sham-controlled trial of auricular PENFS evaluates the clinical utility of PENFS for fibromyalgia as compared to sham placebo control acute and longitudinal PENFS-related neural changes visualized on rs-fcMRI and effects of PENFS on HRV as a potential vagal mechanism of pain relief
HYPOTHESIS True PENFS results in non-placebo-related short-and long-term pain and physical function improvements that can be correlated with altered connectivity and HRV
METHODS For Aim 1 240 total participants meeting 2016 diagnostic criteria for fibromyalgia male and female age 18-60 years old will be randomized to either true n120 or sham n120 auricular PENFS
Neuroimaging data self-reported pain and physical function will be assessed at baseline and at 1- and 12- weeks post-treatment to evaluate neural correlates of PENFS-related treatment Participants who meet study criteria will be randomized to either true or sham PENFS series of 4 weekly treatments and assessed for rsfcMRI and functional changes at 1- and 12-weeks post-treatment Baseline and follow-up rs-fcMRI will be utilized to identify biomarkers of fibromyalgia and PENFS treatment effects for Aim 2 in a subset of 62 participants from Aim 1 who qualify for MRI procedures Cardiopulmonary data will be simultaneously collected during rs-fcMRI and utilized for the exploratory Aim 3 to evaluate potential PENFS effects on HRV as an outcome measure for vagal effects In the initial phase preliminary analytical validation will be accomplished in the first 30 participants following IRB approval hiring and training of staff and establishment of an image processing pipeline If initial milestones are met the rigorous double-blind sham-controlled study in a larger group of Veterans will continue Veterans who are initially assigned to sham placebo PENFS and are not identified as placebo-responders will be offered the opportunity to test the true PENFS device This study addresses the critical need to clinically evaluate non-pharmacologic therapies for chronic pain
OBJECTIVE The proposed Merit a randomized sham-controlled trial of auricular PENFS evaluates the clinical utility of PENFS for fibromyalgia as compared to sham placebo control acute and longitudinal PENFS-related neural changes visualized on rs-fcMRI and effects of PENFS on HRV as a potential vagal mechanism of pain relief
HYPOTHESIS True PENFS results in non-placebo-related short-and long-term pain and physical function improvements that can be correlated with altered connectivity and HRV
METHODS For Aim 1 240 total participants meeting 2016 diagnostic criteria for fibromyalgia male and female age 18-60 years old will be randomized to either true n120 or sham n120 auricular PENFS
Neuroimaging data self-reported pain and physical function will be assessed at baseline and at 1- and 12- weeks post-treatment to evaluate neural correlates of PENFS-related treatment Participants who meet study criteria will be randomized to either true or sham PENFS series of 4 weekly treatments and assessed for rsfcMRI and functional changes at 1- and 12-weeks post-treatment Baseline and follow-up rs-fcMRI will be utilized to identify biomarkers of fibromyalgia and PENFS treatment effects for Aim 2 in a subset of 62 participants from Aim 1 who qualify for MRI procedures Cardiopulmonary data will be simultaneously collected during rs-fcMRI and utilized for the exploratory Aim 3 to evaluate potential PENFS effects on HRV as an outcome measure for vagal effects In the initial phase preliminary analytical validation will be accomplished in the first 30 participants following IRB approval hiring and training of staff and establishment of an image processing pipeline If initial milestones are met the rigorous double-blind sham-controlled study in a larger group of Veterans will continue Veterans who are initially assigned to sham placebo PENFS and are not identified as placebo-responders will be offered the opportunity to test the true PENFS device This study addresses the critical need to clinically evaluate non-pharmacologic therapies for chronic pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I01RX005050 | OTHER_GRANT | VA RRD | None |