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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Washington D.C. Veterans Affairs Medical Center
Study ID
NCT06906211
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • low intensity focused ultrasound (LIFU) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Jan 2025
Primary completion
Jan 26, 2028
Completion
Jan 26, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington DC Veterans Affairs Medical CenterWashington D.C.District of Columbia20422
Mary R Lee, MD
[email protected]
202-745-8000
Evan Lindeman, MS
[email protected]
Mary R Lee, MD (PRINCIPAL_INVESTIGATOR)

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Washington DC Veterans Affairs Medical Center· Washington D.C., DC

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