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

Description

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.

Conditions

Chronic Back Pain, Chronic Pain (back / Neck)

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Back Pain
Intervention / Treatment

-

Contacts and Locations

Washington

Washington DC Veterans Affairs Medical Center, Washington, District of Columbia, United States, 20422

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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
  • * Opiate use daily
  • * Currently pregnant or breast feeding.
  • * Unable to understand the consent form.
  • * History of head injury with loss of consciousness for more than 5 minutes, seizures, history of stroke, brain surgery, brain tumor, multiple sclerosis.
  • * History of metastatic cancer, rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, or polymyositis
  • * Unintended weight loss of 20 pounds or more in the last year
  • * Cauda equina syndrome
  • * Ferromagnetic implants or other contraindications for MRI
  • * Uncompensated congestive heart failure, unstable angina, poorly controlled arrhythmia, active systemic infection end stage renal disease.

Ages Eligible for Study

21 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Washington D.C. Veterans Affairs Medical Center,

Mary R Lee, MD, PRINCIPAL_INVESTIGATOR, Washington D.C. Veterans Affairs Medical Center

Study Record Dates

2028-01-26