# A staged, comprehensive investigation for developing insular deep brain stimulation to treat refractory chronic pain

> **NIH NIH UH3** · UNIVERSITY OF VIRGINIA · 2022 · $1,056,031

## Abstract

PROJECT SUMMARY
Patients with refractory chronic pain typically do not respond to traditional analgesics or weak opioids
as these agents do not directly address the cause for their pain. Many chronic pain patients do not
achieve satisfactory pain relief even with evidence-based treatment, or they do not tolerate effective
doses because of adverse side effects. Deep brain stimulation (DBS) is already an established
treatment for intractable movement disorders and epilepsy, and recent advancements in the fields of
pain neurophysiology and biotechnology may facilitate the use of DBS as a nonpharmacological
therapy for refractory chronic pain.
In the first stage of the proposed project, we will enroll 12 subjects with refractory neuropathic pain to
an inpatient clinical trial for insular brain mapping with acute stimulation and neurophysiological brain
monitoring. Electrodes for stimulating and recording will be implanted stereotactically along the
anterior-posterior axis of the insular cortex. Subjects with positive analgesic effects during acute insular
stimulation in the first stage of the proposed project will continue to the second stage, which will consist
of a randomized, sham-stimulation-controlled, double-blinded, cross-over clinical trial of chronic insular
DBS with the purpose of obtaining safety and efficacy data for this procedure. Furthermore, we aim to
develop neurophysiological biomarkers of pain by studying changes in neural activity.
Safety data, effect size, and insular stimulation parameters obtained from this research will be used in
the design of subsequent clinical trials. The neurophysiological pain biomarkers identified in this project
will also aid the development of a novel, closed-loop insular DBS system, as well as new
diagnostic/prognostic measures for managing chronic pain. If proven to be safe and effective, insular
DBS will offer a much needed non-pharmacological treatment option for patients suffering from
refractory chronic pain.

## Key facts

- **NIH application ID:** 10437978
- **Project number:** 1UH3NS123308-01A1
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** William Jeffrey Elias
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,056,031
- **Award type:** 1
- **Project period:** 2022-09-20 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10437978

## Citation

> US National Institutes of Health, RePORTER application 10437978, A staged, comprehensive investigation for developing insular deep brain stimulation to treat refractory chronic pain (1UH3NS123308-01A1). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10437978. Licensed CC0.

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