# Randomized Double-Blind Placebo-Controlled Trial: fMRI Assessment of Percutaneous  Electrical Neural Field Stimulation for Fibromyalgia in Veterans

> **NIH VA IK2** · VETERANS HEALTH ADMINISTRATION · 2020 · —

## Abstract

CANDIDATE: Dr. Woodbury is an 8/8 VA-paid employed double-board certified anesthesiologist and pain
management clinician who seeks protected time to develop advanced neuroimaging and clinical trials expertise
following successful completion of a CDA-1 feasibility study. ENVIRONMENT: The Center for Visual and
Neurocognitive Research (CVNR) is a VA RR&D Center of Excellence (COE) in research and provides a
robust clinical research environment in conjunction with nearby Emory University. RESEARCH PLAN: In the
setting of the opioid epidemic, it is crucial to develop non-pharmacologic treatments for pain and biomarkers to
accurately assess pain treatment outcomes. In the present investigation, we assess a novel non-
pharmacologic approach to chronic pain treatment in patients suffering from fibromyalgia (a notoriously difficult
to treat pain syndrome), utilizing neuroimaging as a biomarker. Resting state functional connectivity MRI (rs-
fcMRI), a specific neuroimaging technique, has emerged as a reliable research tool to objectively assess,
understand, and predict clinical pain in syndromes such as fibromyalgia. Preliminary results from our CDA-1
investigation reveal a trend towards improved pain and function with a FDA-approved, non-pharmacologic
therapy - auricular percutaneous electrical neural field stimulation (PENFS) - over standard therapy control,
correlating to altered network connectivity on rs-fcMRI. PENFS-related improvements continued through 12
weeks following the completion of treatment and correlated to changes in cross-network connectivity, which
differed between groups. OBJECTIVE: The proposed CDA-2, a randomized, sham-controlled trial of auricular
PENFS, evaluates 1) the clinical utility of PENFS for fibromyalgia as compared to sham placebo control, 2)
short- and long-term PENFS-related neural changes visualized on rs-fcMRI and 3) the ability of rs-fcMRI to
predict PENFS treatment response. HYPOTHESIS: True PENFS results in non-placebo-related short- and
long-term pain and functional improvements that can be correlated with altered connectivity and predicted by
baseline rs-fcMRI. METHODS: Fifty total subjects (male and female veterans, age 20-60 years old) will be
randomized to either sham (n=25) or true (n=25) auricular PENFS. Neuroimaging data, self-reported pain, and
function will be assessed at baseline and at 1 and 12 weeks post-treatment to evaluate neural correlates of
PENFS-related treatment. Subjects who meet study criteria will receive baseline assessments including rs-
fcMRI, Defense and Veterans Pain Rating Scale (DVPRS) measures, PROMIS measures, arm curl, 30-s chair
stand, handgrip strength tests, and baseline analgesic consumption. Subjects will be block-randomized,
stratified based on gender, to either true or sham PENFS (series of 4, weekly) treatments and assessed for rs-
fcMRI and functional changes at 1 and 12 weeks post-treatment. This study addresses the critical need to
identify and understand neural correlate...

## Key facts

- **NIH application ID:** 9835606
- **Project number:** 1IK2RX003227-01
- **Recipient organization:** VETERANS HEALTH ADMINISTRATION
- **Principal Investigator:** Anna Woodbury
- **Activity code:** IK2 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2020
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2019-10-01 → 2024-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9835606

## Citation

> US National Institutes of Health, RePORTER application 9835606, Randomized Double-Blind Placebo-Controlled Trial: fMRI Assessment of Percutaneous  Electrical Neural Field Stimulation for Fibromyalgia in Veterans (1IK2RX003227-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9835606. Licensed CC0.

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