RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-15
Study Completion:2028-01-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06906211

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.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veterans aged 21 to 75 with Chronic Back Pain (CBP).
  2. * CBP duration daily for last 3 months or half of days for last 6 months
  3. * Endorse pain rating of 4/10 BPI-SF
  4. * 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.
  1. * Surgery recommended as primary treatment intervention for CBP
  2. * Current diagnosis of fibromyalgia
  3. * Current substance use disorder other than nicotine.
  4. * Psychiatric disorder and not on a stable pharmacologic regimen for ≥ 4 weeks prior to screening
  5. * Opiate use daily
  6. * Currently pregnant or breast feeding.
  7. * Unable to understand the consent form.
  8. * History of head injury with loss of consciousness for more than 5 minutes, seizures, history of stroke, brain surgery, brain tumor, multiple sclerosis.
  9. * History of metastatic cancer, rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus, or polymyositis
  10. * Unintended weight loss of 20 pounds or more in the last year
  11. * Cauda equina syndrome
  12. * Ferromagnetic implants or other contraindications for MRI
  13. * Uncompensated congestive heart failure, unstable angina, poorly controlled arrhythmia, active systemic infection end stage renal disease.

Contacts and Locations

Study Contact

Mary R Lee, MD
CONTACT
202-745-8000
mary.lee3@va.gov
Evan Evan Lindeman, MS
CONTACT
evan.lindeman@va.gov

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Washington D.C. Veterans Affairs Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-15
Study Completion Date2028-01-26

Study Record Updates

Study Start Date2025-01-15
Study Completion Date2028-01-26

Terms related to this study

Keywords Provided by Researchers

  • low intensity focused ultrasound
  • chronic back pain
  • chronic pain
  • functional magnetic resonance imaging

Additional Relevant MeSH Terms

  • Chronic Back Pain
  • Chronic Pain (back / Neck)