Recruiting

Low Intensity Focused Ultrasound

Sponsor:

Washington D.C. Veterans Affairs Medical Center

Code:

NCT06906211

Conditions

Chronic Back Pain

Chronic Pain (Back / Neck)

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

low intensity focused ultrasound (LIFU)

Study Details

Brief summary:

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)

Study ID

NCT06906211

Start date

Jan 15, 2025

Status verified date

Aug, 2026

Completion date

Jan 26, 2028

Anticipated

Primary completion date

Jan 26, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: LIFU/Sham

double-blind, sham-controlled, crossover study in N=66 individuals with Chronic Back Pain

other: Sham/LIFU

double-blind, sham-controlled, crossover study in N=66 individuals with Chronic Back Pain

Interventions

low intensity focused ultrasound (LIFU)

Low-intensity focused ultrasound (LIFU) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. LIFU is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth. Much lower intensities of focused ultrasound (LIFU) are used so that tissue damage does not occur, but neural activity can be modulated. LIFU utilizes acoustic energy at much lower levels to affect tissue by mechanical effects.

Primary outcome measure

  • Measures of Central Sensitization - Thermal Pain Threshold [ Time Frame: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays ]
  • Measures of Central Sensitization - Temporal Summation of Pain [ Time Frame: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays ]
  • Measures of Central Sensitization - Conditioned Modulation of Pain [ Time Frame: immediately prior to 1 session LIFU and within 1 hour post LIFU; immediately prior to 1 session sham and with in 1 hour post shamdays ]

Central Contacts and Locations

Central contacts

Mary R Lee, MD

202-745-8000mary.lee3@va.gov

Evan Evan Lindeman, MS

evan.lindeman@va.gov

Locations

Washington DC Veterans Affairs Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20422

Contacts

Mary R Lee, MD

202-745-8000mary.lee3@va.gov

Evan Lindeman, MS

evan.lindeman@va.gov

Principal Investigator:

Mary R Lee, MD

More Information

Sponsor

Washington D.C. Veterans Affairs Medical Center

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington D.C. Veterans Affairs Medical Center on 2026-08-25.