Recruiting

Smart Brain Stimulation for Severe Chronic Pain

Plain-English translation of NCT04144972 on ClinicalTrials.gov ↗ · Source last updated July 2025 · Translation generated July 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing a new type of brain stimulation device called the Summit RC+S that works differently than older versions. Instead of constantly stimulating your brain, this device learns to recognize when your pain is worst and turns on only when it's needed — like a smart thermostat for pain. The goal is to help people with severe chronic pain that hasn't gotten better with medications or other treatments.

Many people with chronic pain conditions don't get relief from available medications and treatments, and older brain stimulation devices often stop working well over time. Researchers believe a smarter device that adapts to each person's unique pain patterns could work better and last longer.

Do you qualify?

You likely qualify if…

you are between 22 and 80 years old
you have had severe chronic pain for at least two years that hasn't improved with medications
your pain is rated 6 or higher on a 0-10 pain scale on most days
you have tried at least two different types of pain medications without success
you have been evaluated by surgeons who confirmed your pain cannot be fixed with surgery
you score 25 or higher on a memory and thinking test

You likely don't qualify if…

you have serious medical conditions that make surgery risky, such as uncontrolled high blood pressure, blood clotting problems, or active infections
you have a heart pacemaker, implanted pump, or other brain implants that would conflict with this device
you are pregnant or breastfeeding
you have untreated depression or active suicidal thoughts
you have used illegal drugs or misused medications in the past three years

What participation looks like

You would first stay in the hospital for a trial period where temporary electrodes are placed in your brain to test whether the approach works for you and to identify which brain areas control your pain. If successful, you would have surgery to implant the permanent Summit RC+S device, which records brain signals and delivers stimulation. After that, you would participate in both active (stimulation on) and inactive (stimulation off) periods while researchers collect data to build algorithms that learn your personal pain patterns, with follow-up visits to monitor how well the treatment works.

AI-generated summary from trial data · Jul 4, 2026 · Not medical advice

Trial locations(1 site)

United States

University of California, San Francisco, San Francisco, California