Chronic PainPhase 1/2DBTNCT05674903
Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain
A Phase 1/2 study testing Verum stimulation with Diadem prototype in people with Chronic Pain and Chronic Pain Syndrome, run by University of Utah at 1 site in United States.
Trial summary
This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Chronic Pain Syndrome, Widespread Chronic Pain
- What is being tested?
- Verum stimulation with Diadem prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to 28 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65, any gender
- Primary diagnosis of generalized chronic pain or widespread 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
- History of serious brain injury or other neurologic disorder
- Poorly managed general medical condition
- Pregnant or breast feeding
- Implanted device in the head or neck
- MRI intolerance or contraindication
- Brain stimulation (e.g., VNS, TMS) in the past month
- Lifetime history of a serious suicide attempt (Hooley et al., 2014)
- 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: Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain: A Pilot Study of Target Engagement and Analgesic Effects
This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound 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 trial will evaluate brain target engagement using magnetic resonance imaging and CVAS and PROMIS numerical rating scales of pain.
- Conditions
- Chronic Pain, Chronic Pain Syndrome, Widespread Chronic Pain
- Being tested
- Verum stimulation with Diadem prototype, Sham stimulation with Diadem prototype
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum stimulation with Diadem prototypeDevice
Diadem prototype device delivers focused low-intensity ultrasound stimulation
Sham stimulation with Diadem prototypeDevice
Diadem prototype device delivers active sham, unfocused low-intensity ultrasound stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in pain perception Intervention: Device: Diadem prototype Receives: Device: Verum stimulation with Diadem prototype |
| Sham stimulation | Sham comparator | Low-intensity transcranial focused ultrasound stimulation using unfocused wave Intervention: Device: Diadem prototype Receives: Device: Sham stimulation with Diadem prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target engagement: brain activation
MRI quantification of blood oxygenation level dependent (BOLD) activation.
Measured: 1 day At MRI study visit
Target engagement: brain connectivity
Pearson's correlation of BOLD signals between the stimulated target and connected regions.
Measured: 1 day At MRI study visit
Pain intensity: momentary change
Computerized Visual Analogue Scale. The scale is measured using a continuous slider. At its left boundary, the slider indicates no pain (score 0). At its right boundary, the slider indicates worst pain imaginable (score 100). A lower score indicates a better treatment outcome.
Measured: 1 day At stimulation visit
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: 1 day At stimulation visit
Depression scale: subjective state
PROMIS scale of depression. Scores range from 1 (not at all depressed) to 5 (severely depressed). A lower score indicates a better treatment outcome.
Measured: 1 day At stimulation visit
Anxiety scale: subjective state
PROMIS scale of anxiety. Scores range from 1 (not at all anxious) to 5 (severely anxious). A lower score indicates a better treatment outcome.
Measured: 1 day At stimulation visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start10 Jul 2023
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- 47 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674903
- Sponsor's protocol ID
- IRB_00162656
- Acronym
- DBT
- Status last verified
- Apr 2025
- First submitted
- 3 Jan 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riis TS, Feldman DA, Losser AJ, Okifuji A, Kubanek J. Noninvasive targeted modulation of pain circuits with focused ultrasonic waves. Pain. 2024 Dec 1;165(12):2829-2839. doi: 10.1097/j.pain.0000000000003322. Epub 2024 Jul 30.
PubMed 39073370
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain: A Pilot Study of Target Engagement and Analgesic Effects
- ClinicalTrials.gov ID
- NCT05674903
- Acronym / sponsor ID
- DBT / IRB_00162656
- Conditions
- Chronic Pain, Chronic Pain Syndrome, Widespread Chronic Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 9 Jan 2023 (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 evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound 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 trial will evaluate brain target engagement using magnetic resonance imaging and CVAS and 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 | Experimental | Device: Verum stimulation with Diadem prototypeLow-intensity transcranial focused ultrasound stimulation of deep brain targets involved in pain perception Intervention: Device: Diadem prototype |
| Sham stimulation | Sham comparator | Device: Sham stimulation with Diadem prototypeLow-intensity transcranial focused ultrasound stimulation using unfocused wave Intervention: Device: Diadem prototype |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65, any gender
- Primary diagnosis of generalized chronic pain or widespread 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
Key exclusion criteria (8 listed)
- History of serious brain injury or other neurologic disorder
- Poorly managed general medical condition
- Pregnant or breast feeding
- Implanted device in the head or neck
- MRI intolerance or contraindication
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 |
|---|---|---|
| Verum stimulation with Diadem prototypeDiadem prototype device delivers focused low-intensity ultrasound stimulation | Device | Active stimulation |
| Sham stimulation with Diadem prototypeDiadem prototype device delivers active sham, unfocused low-intensity ultrasound stimulation | Device | Sham stimulation |
Primary outcome
Target engagement: brain activation
Time frame: 1 day At MRI study visit
MRI quantification of blood oxygenation level dependent (BOLD) activation.
Target engagement: brain connectivity
Time frame: 1 day At MRI study visit
Pearson's correlation of BOLD signals between the stimulated target and connected regions.
Pain intensity: momentary change
Time frame: 1 day At stimulation visit
Computerized Visual Analogue Scale. The scale is measured using a continuous slider. At its left boundary, the slider indicates no pain (score 0). At its right boundary, the slider indicates worst pain imaginable (score 100). A lower score indicates a better treatment outcome.
Pain intensity: subjective state
Time frame: 1 day At stimulation visit
PROMIS scale of pain intensity. Scores range from 1 (no pain) to 5 (severe pain). A lower score indicates a better treatment outcome.
Depression scale: subjective state
Time frame: 1 day At stimulation visit
PROMIS scale of depression. Scores range from 1 (not at all depressed) to 5 (severely depressed). A lower score indicates a better treatment outcome.
Anxiety scale: subjective state
Time frame: 1 day At stimulation visit
PROMIS scale of anxiety. Scores range from 1 (not at all anxious) to 5 (severely anxious). A lower score indicates a better treatment outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 39073370Riis TS, Feldman DA, Losser AJ, Okifuji A, Kubanek J. Noninvasive targeted modulation of pain circuits with focused ultrasonic waves. Pain. 2024 Dec 1;165(12):2829-2839. doi: 10.1097/j.pain.0000000000003322. Epub 2024 Jul 30.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Verum stimulation with Diadem prototype in people with Chronic Pain and Chronic Pain Syndrome, 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 25 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Target engagement: brain activation (time frame: 1 day At MRI study visit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674903, which also lists 1 linked publication.
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 25 May 2025.