Deep Brain Stimulation for Chronic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new type of brain stimulation device for people with chronic pain that doesn't respond to other treatments. The device sends electrical signals to different parts of the brain and adjusts these signals based on real-time pain levels. The goal is to provide better and longer-lasting pain relief.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have stable doses of medications for 30 days prior to the baseline visit, which suggests you may need to maintain your current medication regimen.
Is deep brain stimulation generally safe for treating chronic pain?
What makes the Medtronic Summit RC+S treatment unique for chronic pain?
The Medtronic Summit RC+S is unique because it is the first FDA-approved deep brain stimulation device with sensing capabilities, allowing it to record brain signals during active stimulation. This feature may help tailor the treatment to individual patients' needs, potentially improving its effectiveness for chronic pain management.26789
What data supports the effectiveness of the treatment Medtronic Summit RC+S, Medtronic Activa PC+S, Medtronic Summit RC+S, Percept RC for chronic pain?
Research shows that deep brain stimulation (DBS) using Medtronic devices can help reduce chronic pain. In one study, patients experienced pain relief lasting up to seven hours with DBS, and another study showed improvements in pain and other symptoms in patients with complex regional pain syndrome.67101112
Who Is on the Research Team?
Edward Chang, M.D.
Principal Investigator
University of California, San Francisco
Philip Starr, MD
Principal Investigator
University of California, San Francisco
Prasad Shirvalkar, M.D., Ph.D
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for adults aged 22-80 with severe, treatment-resistant chronic pain from conditions like post-traumatic or postsurgical syndromes, nerve injuries, and more. Participants must have had this pain for over two years, failed at least two different pain medications, and not have a correctible cause for the pain. They should be able to understand English and consent to the study. Pregnant women or those with certain medical devices or major health issues can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Inpatient Trial Period
Subjects undergo bilateral surgical implant of temporary electrodes to identify candidate biomarkers of pain and optimal stimulation parameters
Chronic Implantation and Closed-loop DBS Testing
Subgroup of patients receive chronic implantation for long-term recording and stimulation, testing closed-loop DBS algorithms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Medtronic Summit RC+S
Medtronic Summit RC+S is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator