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DBS for Chronic Pain
Study Summary
This trial is testing a new way to provide deep brain stimulation (DBS) for people with chronic pain that has not been relieved by other treatments. DBS involves surgically placing a small device in the brain that sends electrical signals to specific areas. The goal of this trial is to find out whether DBS is more effective when it is turned on only when needed, rather than continuously.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My pain medication doses have been stable.I cannot stop taking blood thinners for surgery.I have had severe pain for over a year that medicine hasn't helped.I need special treatments like ECT or TMS for a long-term condition.I haven't improved with antidepressants, anti-seizure meds, or narcotics.I am an adult with chronic nerve pain that hasn't improved with treatment.I have serious health issues that could make surgery risky.I had brain surgery to manage pain in my thalamus.I experience severe pain after a stroke, spinal injury, or amputation.My daily pain level has been above 5 for the last month.I haven't improved after trying an antidepressant, anti-seizure, and narcotic medication.You have severe depression or other untreated mental health conditions like anxiety, schizophrenia, or bipolar disorder.I have pain after a stroke, spinal injury, or amputated limb with sensitivity changes.I have had severe pain for over a year that hasn’t improved with treatment.I had a stroke caused by a blockage and recent MRI shows damage in specific brain areas.I do not have major neurological disorders like epilepsy or neurodegenerative conditions.My daily pain level has been over 5 for the last month.My recent MRI shows no issues that would prevent surgery for my spinal cord injury pain.My pain medication doses have been stable.I am unable to understand or sign the consent form.I have had severe pain for over a year that medicine doesn't help.You have had problems with drugs or alcohol in the last 3 years.Your recent MRI shows unusual findings not related to your chronic pain condition.You have trouble with memory or thinking, as measured by a test called the MoCA, and scored less than 25.You have a blood clotting problem, unless a hematologist says it's okay for you to participate.You are allergic to the materials used in the Activa PC+S system, such as titanium, polyurethane, silicone, polyetherimide, and stainless steel.My pain medication doses have been stable.If you have trouble speaking or understanding others because of a brain injury, you may not be able to join the study.I haven't improved with antidepressants, anti-seizure meds, or narcotics.I am 21 years old or older.You have tried to harm yourself in the past year, or you are at risk of trying to harm yourself soon.My recent MRI shows no issues that would prevent surgery for my phantom limb pain.I understand the study and can give my consent.
- Group 1: Open-Loop DBS and Closed-Loop DBS
- Group 2: Sham DBS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any open opportunities to participate in this research?
"According to information hosted on clinicaltrials.gov, this trial has ceased recruitment efforts; its last update was registered on May 5th 2022. Even though no new participants are being accepted for this study, there are still 896 other studies actively recruiting patients across the country."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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