Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis

Part of paid clinical trials in Colleyville, Texas.

Sponsor
Surf Therapeutics
Study ID
NCT07293871
Phase
PHASE2
Status
Recruiting
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Conditions

  • Rheumatoid Arthritis (RA

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active treatment — DEVICE
    Daily active ultrasound stimulation
  • Sham (No Treatment) — DEVICE
    Daily sham ultrasound stimulation

Study Details

This two-stage, multicenter clinical trial is designed to evaluate the feasibility, safety, and preliminary efficacy of at-home ultrasound stimulation to activate immune-neuromodulation in patients with rheumatoid arthritis (RA) and at least moderate disease activity. The study will enroll up to 40 participants at up to 6 sites across 2 stages. The findings from this trial will directly inform the design and power calculations for a future pivotal trial by identifying an appropriate effect size and confirming protocol feasibility and safety for a daily home-use therapy.

Key Dates

Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Daily active stimulation for 8 weeks
  • Sham Comparator: Control
    Daily sham stimulation, for 8 weeks, which will look and feel the same as active stimulation, but with no ultrasound energy entering the body

Primary Outcome Measure

Change in high sensitivity CRP (hsCRP) [ Time Frame: 8 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Precision Comprehensive Clinical Research SolutionsColleyvilleTexas75034
Sri Lekha Gaddam
[email protected]
469-498-0417
Dhiman Basu, MD (PRINCIPAL_INVESTIGATOR)
Precision Comprehensive Clinical Research SolutionsIrvingTexas75061
Akshay Shetty
[email protected]
469-498-0420
Renuka Basavaraju, MD (PRINCIPAL_INVESTIGATOR)

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