Neuropathic PainPhase 1/2NCT06249724
Noninvasive Modulation of Chronic Neuropathic Pain
A Phase 1/2 study testing Active stimulation using low-frequency ultrasonic transducer in people with Neuropathic Pain and Chronic Pain, run by University of Utah at 1 site in United States.
Trial summary
This study will apply low-intensity transcranial focused ultrasound to dorsal root ganglia in patients with chronic neuropathic pain. The target will be validated using magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathic Pain, Chronic Pain
- What is being tested?
- Active stimulation using low-frequency ultrasonic transducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2024to 10 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of chronic pain
- Moderate-to-severe chronic pain lasting at least 2 months
- Stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
- For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
- Capacity to provide informed consent; provision of a signed and dated consent form
Who cannot join
- Poorly managed general medical condition
- Pregnant or breast feeding
- Implanted device in the back
- Lifetime history of a serious suicide attempt
- Clinically inappropriate for participation in the study as determined by the study team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Modulation of Chronic Neuropathic Pain With Focused Ultrasonic Waves
This study will apply low-intensity transcranial focused ultrasound to dorsal root ganglia in patients with chronic neuropathic pain. The target will be validated using magnetic resonance imaging. The stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The level of pain will be evaluated using the Numerical Rating Scale (NSR-11) and the Patient-Reported Outcomes Measurement Information System (PROMIS) numerical rating scales of pain.
- Conditions
- Neuropathic Pain, Chronic Pain
- Being tested
- Active stimulation using low-frequency ultrasonic transducer, Sham stimulation using low-frequency ultrasonic transducer
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active stimulation using low-frequency ultrasonic transducerDevice
The ultrasonic transducer delivers focused low-intensity ultrasound stimulation
Sham stimulation using low-frequency ultrasonic transducerDevice
The ultrasonic transducer delivers focused zero-intensity ultrasound stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | Low-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction Receives: Device: Active stimulation using low-frequency ultrasonic transducer |
| Sham stimulation | Sham comparator | Zero-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction Receives: Device: Sham stimulation using low-frequency ultrasonic transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity: momentary change
Numerical Rating Scale (NRS-11) of pain. NRS-11 is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: During the intervention, and every day thereafter, for 7 days
Pain intensity: subjective state
PROMIS scale of pain intensity. Scores range from 1 (no pain) to 5 (severe pain). A lower score indicates a better treatment outcome.
Measured: Immediately after the intervention, and every day thereafter, for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start10 Feb 2024
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Why it stopped: Not activated at the site level
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Kubanek, University of Utah
- Investigators
- Jan Kubanek, PhD, Principal investigator, University of UtahDaniel Odell, MD, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249724
- Sponsor's protocol ID
- IRB_00175546
- Status last verified
- Apr 2025
- First submitted
- 31 Jan 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Modulation of Chronic Neuropathic Pain With Focused Ultrasonic Waves
- ClinicalTrials.gov ID
- NCT06249724
- Acronym / sponsor ID
- IRB_00175546
- Conditions
- Neuropathic Pain, Chronic Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not activated at the site level
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will apply low-intensity transcranial focused ultrasound to dorsal root ganglia in patients with chronic neuropathic pain. The target will be validated using magnetic resonance imaging. The stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The level of pain will be evaluated using the Numerical Rating Scale (NSR-11) and the Patient-Reported Outcomes Measurement Information System (PROMIS) numerical rating scales of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Device: Active stimulation using low-frequency ultrasonic transducerLow-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction |
| Sham stimulation | Sham comparator | Device: Sham stimulation using low-frequency ultrasonic transducerZero-intensity focused ultrasound stimulation of dorsal root ganglion involved in pain conduction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary diagnosis of chronic pain
- Moderate-to-severe chronic pain lasting at least 2 months
- Stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
- For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
- Capacity to provide informed consent; provision of a signed and dated consent form
Key exclusion criteria (5 listed)
- Poorly managed general medical condition
- Pregnant or breast feeding
- Implanted device in the back
- Lifetime history of a serious suicide attempt
- Clinically inappropriate for participation in the study as determined by the study team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active stimulation using low-frequency ultrasonic transducerThe ultrasonic transducer delivers focused low-intensity ultrasound stimulation | Device | Active stimulation |
| Sham stimulation using low-frequency ultrasonic transducerThe ultrasonic transducer delivers focused zero-intensity ultrasound stimulation | Device | Sham stimulation |
Primary outcome
Pain intensity: momentary change
Time frame: During the intervention, and every day thereafter, for 7 days
Numerical Rating Scale (NRS-11) of pain. NRS-11 is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Pain intensity: subjective state
Time frame: Immediately after the intervention, and every day thereafter, for 7 days
PROMIS scale of pain intensity. Scores range from 1 (no pain) to 5 (severe pain). A lower score indicates a better treatment outcome.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Kubanek, PhD principal investigator
University of Utah
Daniel Odell, MD study chair
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Active stimulation using low-frequency ultrasonic transducer in people with Neuropathic Pain and Chronic Pain, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity: momentary change (time frame: During the intervention, and every day thereafter, for 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.