Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorWashington D.C. Veterans Affairs Medical Center

About this trial

In this study, the research team will use low-intensity focused ultrasound (LIFU) to temporarily change brain activity in a brain region that is known to be involved in chronic pain. Through this, the research team hopes to learn about how the brain area works in response to pain. There are main questions this study aims to answer:

* The effect of LIFU to inhibit the posterior region of the insula (PI) compared to sham stimulation in individuals with chronic back pain (CBP) and widespread pain symptoms. * The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of the Neurologic Pain Signature (NPS) in response to evoked thermal pain. * The effect of LIFU to PI compared to sham stimulation to reduce pain intensity and magnitude of Tonic Pain Signature in response to tonic pain.

Eligibility criteria

Qualifiers

Veterans aged 21 to 75 with Chronic Back Pain (CBP).

CBP duration daily for last 3 months or half of days for last 6 months

Endorse pain rating of 4/10 BPI-SF

Evidence of widespread pain symptoms as determined by report of CBP and pain in a contralateral limb (pain in the upper, lower, left or right side of the body) in fewer than 11 sites. Upper body sites include hand, wrist, elbow or shoulder. Lower sites include hip, knee, ankle or foot.

Disqualifiers

Surgery recommended as primary treatment intervention for CBP

Current diagnosis of fibromyalgia

Current substance use disorder other than nicotine.

Psychiatric disorder and not on a stable pharmacologic regimen for ≥ 4 weeks prior to screening

Trial design

Treatments tested in this trial

  • low intensity focused ultrasound (LIFU)

Treatment groups

66 Participants
are divided into 2 treatment groups