NCT06555562

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2026

Completed
Last Updated

January 7, 2026

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

August 3, 2024

Last Update Submit

January 6, 2026

Conditions

Psoriatic ArthritisRheumatoid ArthritisAnkylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • Tumor Necrosis Factor Alpha Concentration Differences

    Measure the change before and after ultrasound stimulation by immunoassay of blood plasma after challenge with LPS.

    Baseline to 2 hours post therapy

Secondary Outcomes (3)

  • Interleuken 1b Concentration Difference

    Baseline to 2 hours and 24 hours post therapy

  • Interleuken IL-6 Concentration Difference

    Baseline to 2 hours and 24 hours post therapy

  • Tumor Necrosis Factor Alpha Concentration Differences

    Baseline to 24 hours post therapy

Study Arms (2)

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

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

Device: Non-active ultrasound stimulation

Interventions

Ultrasound StimulationDEVICE

Ultrasound therapy will be administered to the appropriate target.

Treatment
Non-active ultrasound stimulationDEVICE

Non-active ultrasound therapy will be administered to the appropriate target

Control

Eligibility Criteria

Age22 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Weigh at least 40 kg

You may not qualify if:

  • 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
  • History of substance use disorder or active regular use of substances (nicotine, marijuana, cocaine, psychedelics, stimulants, etc.)
  • Splenomegaly, asplenia, or splenectomy
  • Inflammatory Arthritis Population
  • 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
  • Unable to provide informed consent
  • Took a JAK inhibitor within the last 4 weeks, or likely to start one while participating in this study
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tekton Research

Austin, Texas, 78745, United States

Location

UT Health

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Arthritis, PsoriaticArthritis, RheumatoidSpondylitis, Ankylosing

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesRheumatic DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAxial SpondyloarthritisAnkylosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2024

First Posted

August 15, 2024

Study Start

October 1, 2025

Primary Completion

January 5, 2026

Study Completion

January 5, 2026

Last Updated

January 7, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)