Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis

Part of paid clinical trials in Colleyville, Texas.

Sponsor
Surf Therapeutics
Study ID
NCT07293871
Status
Recruiting
Apply to this trial

Conditions

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 splenic ultrasound stimulation to activate immune-neuromodulation (SUSTAIN) in patients with rheumatoid arthritis (RA) and at least moderate disease activity. 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.

Key Dates

First listed
Dec 19, 2025
Start date
Mar 20, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Apr 30, 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

Incidence of Adverse Events [ Time Frame: 12 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Precision Comprehensive Clinical Research SolutionsColleyvilleTexas75034
Sri Lekha Gaddam
[email protected]
469-498-0417
Dhiman Basu, MD (PRINCIPAL_INVESTIGATOR)
Rheumatology AssociatesDallasTexas75231
Holly Hoefer
[email protected]
214-550-3029
Robert Jenkins, MD, PhD (PRINCIPAL_INVESTIGATOR)
Precision Comprehensive Clinical Research SolutionsIrvingTexas75061
Akshay Shetty
[email protected]
469-498-0420
Renuka Basavaraju, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Colleyville, TX

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Precision Comprehensive Clinical Research Solutions· Colleyville, TXRheumatology Associates· Dallas, TXPrecision Comprehensive Clinical Research Solutions· Irving, TX

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