Psoriatic ArthritisNCT06555562
Activating the Cholinergic Anti-Inflammatory Pathway in Healthy Volunteers and People With Inflammatory Arthritis
A study testing Ultrasound Stimulation and Non-active ultrasound stimulation in people with Psoriatic Arthritis and Rheumatoid Arthritis, run by Surf Therapeutics at 2 sites in United States.
Trial summary
This study is designed to investigate whether non-invasive ultrasound (US) that is optimized for stimulation and can elicit an anti-inflammatory response in people with Inflammatory Arthritis as compared to a sham intervention. Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- What is being tested?
- Ultrasound Stimulation and Non-active ultrasound stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2025to 5 Jan 2026
- Phase
- Interventional
- 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 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 22-75 years of age
- Weigh at least 40 kg
- 22-75 years of age
- Weigh at least 40 kg
- Diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis of at least 6 months duration as defined by ACR guidelines
- Able to continue the same stable dose of immunomodulatory medication(s) while participating in the study
Who cannot join
- Any physical disabilities, conditions, or diseases that limit the capacity to participate in study procedures or increase the risk of harm as determined by the study PI
- Unable to provide informed consent
- Active bacterial or viral infection
- Class II obesity with a BMI of 35 or higher
- Pregnant women or those trying to become pregnant
- Active use of tobacco/nicotine products
Show all 30Show fewer
- History of substance use disorder or active regular use of substances (nicotine, marijuana, cocaine, psychedelics, stimulants, etc.)
- Splenomegaly, asplenia, or splenectomy
- Inflammatory Arthritis Population
- Unable to provide informed consent
- Took a JAK inhibitor within the last 4 weeks, or likely to start one while participating in this study
- Started a conventional synthetic DMARD (csDMARD) within the last 8 weeks or had a change in prescription within the last 4 week
- Started a Tumor Necrosis Factor (TNF) inhibitor within the last 5 months or had a change in prescription within the last 3 months
- Started any other biologic or targeted synthetic DMARD within the last 3 months, or likely to start one while participating in the study
- Started a corticosteroid, had a change in prescription, or on a stable dose = or > 10 mg of prednisone daily within the last 4 weeks
- Regular use of epinephrine like medications (cold, cough, congestion, or sinus medications, bronchodilators, appetite suppressants)
- Active use of tobacco/nicotine products
- History of substance use disorder or likely use of substances during the study period (marijuana, opioids/heroin, cocaine, psychedelics, methamphetamine, etc.)
- Active bacterial or viral infection
- Receiving chemotherapy or immunotherapy to treat malignancy
- Significant immunodeficiency due to underlying illness
- Class II obesity with a BMI of 35 or higher
- Pregnant women or those trying to become pregnant
- Wound, rash, infection, or traumatic injury over the target area
- Vagal nerve injury or vagotomy
- Surgery or major traumatic injury in the past 90 days
- Chronically-implanted medical devices (i.e. pacemaker, AICD, vagus nerve stimulator, spinal cord stimulator)
- Clinically significant cardiovascular disease
- CKD Stage 3 or higher
- Uncontrolled fibromyalgia or other diffuse pain syndromes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tekton Research
Austin, Texas, 78745
UT Health
Houston, Texas, 77030
About this study
Official title: Activating the Cholinergic Anti-Inflammatory Pathway With Focused Ultrasound Stimulation in Healthy Volunteers and People With Inflammatory Arthritis
This study is designed to investigate whether non-invasive ultrasound (US) that is optimized for stimulation and can elicit an anti-inflammatory response in people with Inflammatory Arthritis as compared to a sham intervention. The primary endpoint is the change in pro-inflammatory cytokines in blood drawn before and after US. Each participant receives 4 experimental US sessions, one of which is randomly assigned to be placebo.
Read the detailed description
The CAP has demonstrated potential as a treatment for various autoimmune and inflammatory disorders, including inflammatory arthritis (Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis) and Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease).
The target populations for this study include healthy volunteers and individuals aged 22-75 years diagnosed with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) by a board-certified rheumatologist.
Up to 20 healthy volunteers and 40 individuals with RA or PsA will be enrolled. After an initial blood draw, participants will receive either active or sham ultrasound during each visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. The visit in which the sham is administered will be determined according to the Randomization Table. To ensure participant safety, the ultrasound parameters used for the active sessions will not exceed the FDA's limits.
After the US is completed, participants should be asked to wait in the clinic for a few hours following the completion of the US intervention, after which they will have a second blood draw. Once the second blood draw is completed, participants may leave and resume their regular diet. Participants will be asked to return after 24 hours of their intervention for their third blood draw.
- Being tested
- Ultrasound Stimulation, Non-active ultrasound stimulation
- Medical subject headings
- Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound StimulationDevice
Ultrasound therapy will be administered to the appropriate target.
Non-active ultrasound stimulationDevice
Non-active ultrasound therapy will be administered to the appropriate target
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants will receive active treatment during the visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. Patient is blinded to the treatment. The visit in which the sham is administered will be determined according to the Randomization Table Receives: Device: Ultrasound Stimulation |
| Control | Sham comparator | Participants will receive a non-active treatment during the visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. Patient is blinded to the treatment. The visit in which the sham is administered will be determined according to the Randomization Table Receives: Device: Non-active ultrasound stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Necrosis Factor Alpha Concentration Differences
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Measured: Baseline to 2 hours post therapy
Secondary outcomes (3)
Interleuken 1b Concentration Difference
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Measured: Baseline to 2 hours and 24 hours post therapy
Interleuken IL-6 Concentration Difference
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Measured: Baseline to 2 hours and 24 hours post therapy
Tumor Necrosis Factor Alpha Concentration Differences
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
Measured: Baseline to 24 hours post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Oct 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surf Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555562
- Sponsor's protocol ID
- SURF_CLN_002
- Status last verified
- Nov 2025
- First submitted
- 3 Aug 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating the Cholinergic Anti-Inflammatory Pathway With Focused Ultrasound Stimulation in Healthy Volunteers and People With Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT06555562
- Acronym / sponsor ID
- SURF_CLN_002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Surf TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 15 Aug 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 is designed to investigate whether non-invasive ultrasound (US) that is optimized for stimulation and can elicit an anti-inflammatory response in people with Inflammatory Arthritis as compared to a sham intervention. The primary endpoint is the change in pro-inflammatory cytokines in blood drawn before and after US. Each participant receives 4 experimental US sessions, one of which is randomly assigned to be placebo.
Detailed description
The CAP has demonstrated potential as a treatment for various autoimmune and inflammatory disorders, including inflammatory arthritis (Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis) and Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease).
The target populations for this study include healthy volunteers and individuals aged 22-75 years diagnosed with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) by a board-certified rheumatologist.
Up to 20 healthy volunteers and 40 individuals with RA or PsA will be enrolled. After an initial blood draw, participants will receive either active or sham ultrasound during each visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. The visit in which the sham is administered will be determined according to the Randomization Table. To ensure participant safety, the ultrasound parameters used for the active sessions will not exceed the FDA's limits.
After the US is completed, participants should be asked to wait in the clinic for a few hours following the completion of the US intervention, after which they will have a second blood draw. Once the second blood draw is completed, participants may leave and resume their regular diet. Participants will be asked to return after 24 hours of their intervention for their third blood draw.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Ultrasound StimulationParticipants will receive active treatment during the visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. Patient is blinded to the treatment. The visit in which the sham is administered will be determined according to the Randomization Table |
| Control | Sham comparator | Device: Non-active ultrasound stimulationParticipants will receive a non-active treatment during the visit. There will be a total of 5 visits involving ultrasound, with 2 being a sham and 3 being active. Patient is blinded to the treatment. The visit in which the sham is administered will be determined according to the Randomization Table |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 22-75 years of age
- Weigh at least 40 kg
- 22-75 years of age
- Weigh at least 40 kg
- Diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis of at least 6 months duration as defined by ACR guidelines
Key exclusion criteria (30 listed)
- Any physical disabilities, conditions, or diseases that limit the capacity to participate in study procedures or increase the risk of harm as determined by the study PI
- Unable to provide informed consent
- Active bacterial or viral infection
- Class II obesity with a BMI of 35 or higher
- Pregnant women or those trying to become pregnant
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 |
|---|---|---|
| Ultrasound StimulationUltrasound therapy will be administered to the appropriate target. | Device | Treatment |
| Non-active ultrasound stimulationNon-active ultrasound therapy will be administered to the appropriate target | Device | Control |
Primary outcome
Tumor Necrosis Factor Alpha Concentration Differences
Time frame: Baseline to 2 hours post therapy
Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.
3 secondary outcomes
Interleuken 1b Concentration Difference
Time frame: Baseline to 2 hours and 24 hours post therapy
Interleuken IL-6 Concentration Difference
Time frame: Baseline to 2 hours and 24 hours post therapy
Tumor Necrosis Factor Alpha Concentration Differences
Time frame: Baseline to 24 hours post therapy
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 7 Jan 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Stimulation and Non-active ultrasound stimulation in people with Psoriatic Arthritis and Rheumatoid Arthritis, run by Surf Therapeutics at 2 sites 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 30 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Tumor Necrosis Factor Alpha Concentration Differences (time frame: Baseline to 2 hours post therapy). 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 7 Jan 2026.