DBS for Chronic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but current technology is unable to reliably achieve long-term pain symptom relief. A "one-size-fits-all" approach of continuous, 24/7 brain stimulation has helped patients with some movement disorders, but the key to reducing pain may be the activation of stimulation only when needed, as this may help keep the brain from adapting to stimulation effects. By expanding the technological capabilities of an investigative brain stimulation device, the investigators will enable the delivery of stimulation only when pain signals in the brain are high, and then test whether this more personalized stimulation leads to reliable symptom relief for chronic pain patients over extended periods of time.
Will I have to stop taking my current medications?
The trial requires that participants have stable doses of their current pain medications, so you will not need to stop taking them. However, if you are on Coumadin or platelet anti-aggregation therapy, you may need to discuss with your doctor about stopping these for surgery.
Is spinal cord stimulation safe for treating chronic pain?
Research shows that spinal cord stimulation (SCS) is generally safe for treating chronic pain. Studies report no device failures or unexpected adverse events, and complications are consistent with other SCS literature. Patients often find the devices easy to use, though some experience issues like failed recharges or interruptions.12345
How does the treatment Medtronic Activa PC+S for chronic pain differ from other treatments?
The Medtronic Activa PC+S is a deep brain stimulation (DBS) device, which is unique because it involves implanting electrodes in specific brain areas to modulate pain signals, offering an option for chronic pain patients who have not found relief with other medical or surgical therapies. Unlike traditional pain medications, DBS targets the brain directly and can be adjusted to the patient's needs, providing a personalized approach to pain management.678910
What data supports the effectiveness of the treatment Medtronic Activa PC+S for chronic pain?
Deep brain stimulation (DBS) has shown success in treating chronic pain in selected patients, especially those with pain after amputation, stroke, or multiple sclerosis. Although DBS for pain fell out of favor due to past trial results, newer techniques and better patient selection have led to improved outcomes in some cases.67111213
Who Is on the Research Team?
Edward Chang, M.D.
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?
Adults over 21 with severe chronic pain from conditions like post-stroke pain, spinal cord injury, or phantom limb pain that hasn't improved after trying several medications. They must be able to speak/read English and women should use contraception. Excluded are those with incompatible implants, cognitive impairments, recent substance abuse, major medical issues increasing surgery risk, or who can't stop certain blood thinners.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Biomarker Identification
Identify biomarkers of low and high pain states to define optimal neural signals for pain prediction
Closed-loop Algorithm Development
Develop closed-loop algorithms for DBS and test feasibility and efficacy in a single-blinded, sham controlled trial
Efficacy Assessment
Assess the efficacy of closed-loop DBS algorithms against traditional open-loop DBS and mechanisms of DBS tolerance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Medtronic Activa PC+S
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Prasad Shirvalkar, MD, PhD
Lead Sponsor
United States Department of Defense
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator