Key Points
- This research will evaluate whether Surf Therapeutic’s neuromodulation device can be used to activate a known anti-inflammatory pathway to relieve the symptoms of rheumatoid arthritis.
- The trial is taking place at two sites in Texas, but the company ultimately intends for patients to use the device at home.
A new clinical trial (NCT07293871) has begun to test Surf Therapeutics’ noninvasive ultrasound neuromodulation device for the treatment of rheumatoid arthritis (RA). The trial – called SUSTAIN – aims to activate the spleen-brain neural reflex, a known anti-inflammatory pathway, without drugs, surgery, or implanted hardware.
RA is a chronic disease that causes inflammation around the body and pain in the joints. Left untreated, RA can cause severe damage to the joints and surrounding tissue as well as heart, lung, or nervous system problems. It affects approximately 1.5 million people in the US, most of whom are women.
The Surf Therapeutics device seeks to leverage a broad beam ultrasound platform and noninvasively stimulate nerves that signal the immune system to reduce inflammation, offering a potential alternative to traditional therapies. The company intends for the device to be used at home by patients, rather than in a clinical setting.
The clinical trial, which is enrolling participants at two clinical sites in Texas, is co-led by Dhiman Basu, MD, and Renuka Basavaraju, MD, both of whom are internal medicine physicians who specialize in rheumatology. Up to 40 participants will be enrolled in two phases: an initial open-label pilot of 10 patients followed by a 30-patient randomized, double-blinded, sham-controlled segment. Participants will be followed for 12 weeks to assess treatment safety and durability as well as immunologic effects.
“The launch of our trial represents an important step in building a rigorous clinical foundation for our ultrasound neuromodulation platform,” said Alex Sackeim, MD, co-founder and chief medical officer of Surf Therapeutics. “People living with rheumatoid arthritis continue to face safety and accessibility issues with existing therapies. Our goal is to deliver a noninvasive solution that is intended to explore an alternative approach to existing and emerging therapeutic modalities, while prioritizing patient safety and accessibility.”