Sound waves aimed at the brain could quiet chronic pain
NCT ID NCT06906211
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This study tests whether low-intensity focused ultrasound (LIFU) can temporarily change activity in a brain area called the insula, which is involved in chronic pain. Veterans with chronic back pain and widespread pain symptoms will receive either real or sham LIFU to see if it reduces pain intensity and changes how the brain responds to heat and other pain triggers. The goal is to learn whether this non-invasive technique could offer a new way to manage chronic pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-intensity focused ultrasound (LIFU), a non-invasive device that uses sound waves to temporarily change brain activity
- What this could lead to
- If it works, this could point toward a new non-invasive way to treat chronic back pain by calming the brain's pain response.
- What could go wrong
- This is an early-stage study with a small number of participants, so results may not apply broadly. The effect is temporary, and the approach may not lead to lasting pain relief.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Washington DC Veterans Affairs Medical Center
RECRUITINGWashington D.C., District of Columbia, 20422, United States
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Other studies related to the condition(s) this trial covers.
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